[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Daewoong Pharmaceutical Co. LTD.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":456},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,20,0,[8,42,67,90,117,139,161,189,213,232,252,270,289,308,332,355,376,395,418,437],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100572693","phase-1-phase-1-clinical-trial-to-evaluate-safety-tolerability-pharmacokinetics-and-pharmacodynamics-of-dwp212525-in-healthy-volunteers-100572693",false,"NCT06736587","Phase 1 Clinical Trial to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of DWP212525 in Healthy Volunteers","A Randomized, Double-blind, Placebo-controlled, Single and Multiple Dose, Dose-escalation Phase 1 Clinical Trial to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of DWP212525 in Healthy Volunteers","Inclusion Criteria:\n\n1. Healthy adult volunteers aged 19 to 55 years\n2. Those with a body weight ≥ 50.0 kg to ≤ 90.0 kg with a body mass index (BMI) of ≥ 18.0 kg\u002Fm2 to ≤ 30.0 kg\u002Fm2\n3. Received a sufficient explanation on this study\n4. Eligible as subjects in the study\n\nExclusion Criteria:\n\n1. History of diseases such as clinically significant disease of hepatobiliary\n2. Following conditions applicable to clinically significant acute or chronic infections or the past history confirmed via an interview\n3. Hemato-oncologic diseases, including malignant tumor diagnosis\n4. Past history of tuberculosis infection or confirmed tuberculosis in the IGRA test and chest X-ray test",true,"ALL","19 Years","55 Years",{"count":21,"type":22},84,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","The safety and tolerability of single and multiple administration of DWP212525",[28],"Autoimmune Diseases","RECRUITING","2026-06-03",{"date":32,"type":33},"2026-06-08","ACTUAL",{"date":35,"type":33},"2024-12-10",{"date":37,"type":22},"2027-03-30",{"name":39,"class":40},"Daewoong Pharmaceutical Co. LTD.","INDUSTRY",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":17,"minAge":49,"maxAge":50,"enrollmentInfo":51,"targetDuration":4,"studyType":23,"phases":53,"briefSummary":55,"conditions":56,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":41},"100638351","phase-3-to-evaluate-the-efficacy-and-safety-of-initial-combination-therapy-with-dwp16001-and-dwc202518-compared-to-dwp16001-monotherapy-and-dwc202518-monotherapy-in-patients-with-type-2-diabetes-mellitus-100638351","NCT07619833","To Evaluate the Efficacy and Safety of Initial Combination Therapy With DWP16001 and DWC202518 Compared to DWP16001 Monotherapy and DWC202518 Monotherapy in Patients With Type 2 Diabetes Mellitus","A Multicenter, Randomized, Double-Blind, Active-Controlled, Parallel-Group, Phase III Study to Evaluate the Efficacy and Safety of Initial Combination Therapy With DWP16001 and DWC202518 Compared to DWP16001 Monotherapy and DWC202518 Monotherapy in Patients With Type 2 Diabetes Mellitus","Inclusion Criteria:\n\n1. Able and willing to cooperate and participate in this clinical study after understanding the study explanation, and capable of voluntarily signing the written informed consent form before any assessments are performed.\n2. Male or female adult aged ≥18 and ≤80 years. Note: The minimum legal age of adult dependent on local regulations. The legal age of adult in Korea is 19 years, while in Indonesia, it is 18 years.\n3. Have been diagnosed with T2DM based on American Diabetes Association (ADA) guidelines (2025) before screening.\n4. Participants must meet one of the following conditions at Visit 1 (Screening):\n\n   * Have an HbA1c ≥7.5% and ≤11% at Visit 1 (Screening) and either have never taken oral anti-diabetic medication since diagnosis or have not taken any oral anti-diabetic medication within 12 weeks prior to screening.\n   * Have an HbA1c ≥6.5% and ≤10.5% at Visit 1 (Screening) and are currently taking one type of oral anti-diabetic medication at screening.\n\n   Note: The HbA1c level at Visit 1 can be measured by the local laboratory.\n5. Have an FPG \\\u003C15 mmol\u002FL (270 mg\u002FdL), as measured by local laboratory at Visit 1.\n6. Participants must meet all the following conditions at Visit 2 (Baseline):\n\n   * Have an HbA1c ≥7.5% and ≤11%, as measured by the central laboratory at Visit 1-1.\n   * Have an FPG \\\u003C15 mmol\u002FL (270 mg\u002FdL), as measured by central laboratory at Visit 1-1.\n7. Have a BMI ≥20 kg\u002Fm2 and ≤45 kg\u002Fm2 at screening.\n8. Women of childbearing potential (WOCBP) must have a negative pregnancy test at screening. WOCBP and their partners must use highly effective, medically accepted contraception to prevent pregnancy and must not have pregnancy or fertility plans throughout the study and for at least 4 weeks after the last dose of study medication\n9. Male participants must agree to use highly effective, medically accepted contraception and refrain from donating sperm throughout the study and for at least 4 weeks after the last dose of study medication\n\nExclusion Criteria:\n\n* Type 1 diabetes mellitus, congenital diabetes, secondary diabetes, or history of diabetic ketoacidosis, diabetic coma, or precoma\n* Severe diabetes-related complications, including proliferative diabetic retinopathy, advanced nephropathy, or severe diabetic neuropathy\n* Clinically significant renal disease, severe gastrointestinal disease or surgery affecting gastrointestinal absorption, pancreatitis, clinically significant urinary\u002Fgenital infections, dehydration requiring treatment, or uncontrolled thyroid disease\n* Clinically significant cardiovascular or cerebrovascular disease within 6 months prior to screening, including myocardial infarction, unstable angina, stroke, clinically significant arrhythmia requiring treatment, or New York Heart Association (NYHA) class III-IV heart failure\n* Active or untreated malignancy, or clinically significant malignancy within the previous 5 years (except adequately treated localized skin cancers or in situ carcinomas)\n* Hematologic conditions that may interfere with HbA1c measurement\n* Clinically significant endocrine disorders affecting glucose metabolism\n* Known or suspected hypersensitivity to study treatment or related products\n* Screening laboratory abnormalities including:\n\nㆍ Fasting C-peptide ≤0.60 ng\u002FmL ㆍ Triglycerides \\>500 mg\u002FdL ㆍ eGFR \\\u003C60 mL\u002Fmin\u002F1.73m² ㆍ AST or ALT ≥3× upper limit of normal (ULN), or total bilirubin ≥2× ULN\n\n* Positive hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) infection meeting protocol-defined criteria\n* Uncontrolled hypertension (systolic blood pressure \\>180 mmHg and\u002For diastolic blood pressure \\>110 mmHg)\n* Prior use of prohibited antidiabetic therapies, including prior antidiabetic combination therapy, thiazolidinediones within 12 weeks, or GLP-1 receptor agonists or insulin within 6 months before screening\n* Use of weight-loss medications within 3 months prior to screening or between screening and baseline\n* Use of systemic corticosteroids at pharmacologic doses within 1 month prior to screening or between screening and baseline","18 Years","80 Years",{"count":52,"type":22},510,[54],"PHASE3","This study aims to evaluate the efficacy and safety of initial combination therapy with DWP16001 and DWC202518 compared to DWP16001 monotherapy and DWC202518 monotherapy in patients with Type 2 Diabetes Mellitus",[57],"T2DM (Type 2 Diabetes Mellitus)","NOT_YET_RECRUITING","2026-05-26",{"date":61,"type":33},"2026-06-02",{"date":63,"type":22},"2026-06",{"date":65,"type":22},"2027-11",{"name":39,"class":40},{"id":68,"slug":69,"hasResults":11,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":4,"eligibilityCriteria":73,"healthyVolunteers":11,"sex":74,"minAge":18,"maxAge":4,"enrollmentInfo":75,"targetDuration":4,"studyType":23,"phases":77,"briefSummary":78,"conditions":79,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":41},"100621475","phase-1-bioequivalence-study-of-dwz2501-in-patients-with-advanced-brca-mutated-high-grade-ovarian-cancer-100621475","NCT07371104","Bioequivalence Study of DWZ2501 in Patients With Advanced BRCA-mutated High-grade Ovarian Cancer","A Multicenter, Open-label, Randomized, Multi-dose, 2-sequence, 2-period, Crossover Bioequivalence Study to Comparison of the Pharmacokinetics and Safety of DWZ2501 and DWC202510 in Patients With Advanced BRCA-mutated High-grade Ovarian Cancer","Inclusion Criteria:\n\n1\\. Female subjects aged 19 years or older at the time of obtaining written informed consent.\n\n2\\. Patients with advanced high-grade ovarian cancer harboring a BRCA mutation. 3. Subjects who meet at least one of the following criteria:\n\n1. Subjects who have been maintained on an olaparib dosing regimen of 300 mg (two 150 mg tablets) administered orally twice daily for at least 10 consecutive days.\n2. Subjects who, in the judgment of the principal investigator require a stable dose of olaparib 300 mg (two 150 mg tablets) administered orally twice daily 4. Subjects with an estimated life expectancy of at least 12 weeks. 5. Subjects with a body mass index(BMI) between 18.50 and 30.00 kg\u002Fm² at screening.\n\nExclusion Criteria:\n\n1. Subjects with a history of hypersensitivity to the investigational product or any of its components.\n2. Subjects with any of the following concomitant conditions:\n\n(1) Pneumonitis (2) Myelodysplastic syndrome or acute myeloid leukemia (3) Severe hepatic impairment(Child-Pugh class C). (4) Ongoing active infection or uncontrolled systemic disease (5) Active hepatitis B, hepatitis C, human immunodeficiency virus(HIV) infection, or syphilis.\n\n3\\. Subjects who have received the following drug and non-drug treatments at screening:\n\n1. Radiotherapy within 4 weeks prior to screening.\n2. Other anticancer therapies within 4 weeks prior to screening. 4. Subjects who have undergone major surgery within 4 weeks prior to screening or who have not adequately recovered from a previous major surgery.\n\n5\\. Subjects who have experienced blood loss of approximately 350 mL or more within 12 weeks prior to screening.","FEMALE",{"count":76,"type":22},40,[25],"A Multicenter, Open-label, Randomized, Multi-dose, 2-sequence, 2-period, Crossover Bioequivalence Study to Comparison of the Pharmacokinetics and Safety of DWZ2501 and DWC202510 in Patients with Advanced BRCA-mutated High-grade Ovarian Cancer",[80,81],"Cancer","Ovarian Cancer","2026-05-06",{"date":84,"type":33},"2026-05-08",{"date":86,"type":33},"2026-04-22",{"date":88,"type":22},"2027-03",{"name":39,"class":40},{"id":91,"slug":92,"hasResults":11,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":4,"eligibilityCriteria":96,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":97,"targetDuration":4,"studyType":99,"phases":4,"briefSummary":100,"conditions":101,"keywords":104,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":113,"completionDateStruct":114,"leadSponsor":116,"locationsCount":41},"100635901","fexuclue-for-prevention-of-nsaids-induced-peptic-ulcer-in-real-world-practice-100635901","NCT07558707","Fexuclue for Prevention of NSAIDs-Induced Peptic Ulcer in Real-World Practice","A Prospective, Multi-Center, Observational Study to Evaluate the Efficacy and Safety of Fexuclue Tablet 20 mg in Patients Requiring NSAIDs-Induced Peptic Ulcer Prevention","Inclusion Criteria:\n\n* Adults aged ≥19 years\n* Patients requiring NSAIDs therapy\n* Patients requiring prevention of NSAIDs-induced peptic ulcer\n* Patients prescribed Fexuclue Tablet 20 mg\n* Patients who provide written informed consent\n\nExclusion Criteria:\n\n* Hypersensitivity to Fexuclue or its components\n* Severe hepatic impairment\n* Pregnant or breastfeeding women\n* Patients considered inappropriate by investigator",{"count":98,"type":22},7000,"OBSERVATIONAL","This study is a prospective, multi-center, observational study to evaluate the efficacy and safety of Fexuclue Tablet 20 mg in patients requiring prevention of NSAIDs-induced peptic ulcer in real-world clinical practice in Korea.\n\nPatients receiving NSAIDs and requiring gastroprotective therapy will be enrolled and followed prospectively. The study will assess patient-reported outcomes (PROs) related to gastrointestinal symptoms, as well as safety outcomes.",[102,103],"Peptic Ulcer","NSAID-Induced Peptic Ulcer",[105,106,107,108,109],"NSAIDs","Fexuprazan","PRO","Real-World","Peptic Ulcer Prevention","2026-04-27",{"date":112,"type":33},"2026-04-30",{"date":112,"type":22},{"date":115,"type":22},"2027-12-31",{"name":39,"class":40},{"id":118,"slug":119,"hasResults":11,"nctId":120,"briefTitle":121,"officialTitle":122,"acronym":4,"eligibilityCriteria":123,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":124,"targetDuration":4,"studyType":23,"phases":126,"briefSummary":128,"conditions":129,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":132,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":41},"100633944","phase-4-study-to-evaluate-the-efficacy-and-safety-of-fexuprazan-in-prevention-of-nsaids-induced-peptic-ulcer-100633944","NCT07533266","Study to Evaluate the Efficacy and Safety of Fexuprazan in Prevention of NSAIDs Induced Peptic Ulcer","A Multi-center, Randomized, Double-blind, Parallel-group, Active-controlled, Phase IV Clinical Trial to Evaluate the Efficacy and Safety of Fexuclue Tab. in Prevention of NSAIDs-induced Peptic Ulcer","Inclusion Criteria:\n\n1. Male and female adults aged ≥ 19 years at the time of informed consent\n2. Subjects who are diagnosed with musculoskeletal disease at screening and require continued treatment with NSAIDs for at least 24 weeks\n3. Subjects with at least one of the following risk factors for ulcer development at screening.\n4. Subjects who have no gastric or duodenal mucosal break or have ulcer in the scarring stage based on the EGD result at screening.\n\nExclusion Criteria:\n\n1. Subjects with esophagitis, gastroesophageal varix, esophagus, Barrett's esophagus, acute gastrointestinal bleeding and else based on the screening EGD results.\n2. Subjects who have undergone gastroduodenal surgery or total small bowel resection\n3. Subjects with history of clinically significant disease of hepatic, renal, nervous, pulmonary, endocrine, hemato-oncologic, cardiovascular or urinary system\n4. Subjects who have had a malignant tumor in the last 5 years\n5. Subjects who history of hypersensitivity to the IP ingredients, aspirin and NSAIDs",{"count":125,"type":22},360,[127],"PHASE4","The study aims to demonstrate the preventive effect of Fexuprazan 20 mg for peptic ulcer is non-inferior to that of Lansoprazole 15 mg in terms of prevention of peptic ulcer and confirm the safety of Fexuprazan 20 mg.",[130],"NSAID (Non-Steroidal Anti-Inflammatory Drug)","2026-04-14",{"date":133,"type":33},"2026-04-16",{"date":135,"type":22},"2026-04",{"date":137,"type":22},"2027-12",{"name":39,"class":40},{"id":140,"slug":141,"hasResults":11,"nctId":142,"briefTitle":143,"officialTitle":143,"acronym":4,"eligibilityCriteria":144,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":145,"enrollmentInfo":146,"targetDuration":4,"studyType":23,"phases":148,"briefSummary":149,"conditions":150,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":153,"lastUpdatePostDateStruct":154,"startDateStruct":156,"completionDateStruct":158,"leadSponsor":160,"locationsCount":41},"100634417","phase-1-a-phase-1-clinical-trial-to-assess-the-safety-of-dwrx5003-and-relative-bioavailability-to-dwc202502-and-dwc202503-in-healthy-adult-volunteers-100634417","NCT07539415","A Phase 1 Clinical Trial to Assess the Safety of DWRX5003 and Relative Bioavailability to DWC202502 and DWC202503 in Healthy Adult Volunteers","Inclusion Criteria:\n\n1. Healthy adult volunteers aged ≥ 19 and ≤ 65 years at screening\n2. Subjects with a body weight ≥ 50.0 kg to ≤ 100.0 kg and a BMI of ≥ 20.0 kg\u002Fm2 to ≤ 29.9 kg\u002Fm2 at screening\n3. Subjects with no congenital disease or chronic disease requiring treatment as well as no pathologic symptoms or findings based on medical examination\n4. Subjects who are determined to be eligible for this study based on results of laboratory tests, vital signs, physical examination, 12-lead electrocardiogram (ECG), etc. set and performed according to the nature of the IP at screening\n5. Subjects who voluntarily decided to participate in the study and provided written consent to follow subject compliance requirements during the study after receiving a detailed explanation on this study and fully understanding the information\n\nExclusion Criteria:\n\n1. Subjects with past or current medical history of clinically significant hepatic, renal, neurological, psychiatric, respiratory, endocrine, hematologic, oncologic, genitourinary, cardiovascular, digestive, and musculoskeletal diseases:\n2. Females who are pregnant (serum-HCG positive) or breast-feeding\n3. Subjects with a history of hypersensitivity (e.g., anaphylaxis or angioedema) or clinically significant hypersensitivity to the active ingredient of the IP, pharmaceutical excipients, or other drugs (e.g., GLP-1 receptor agonists)\n4. Subjects with a history of skin disease (e.g., burns, skin cancer, etc.) or skin transplant surgery that could affect the absorption of the investigational product\n5. Subjects with a history of acute or chronic pancreatitis\n6. Subjects with a personal or family history of medullary thyroid cancer or multiple endocrine neoplasia type 2 (MEN2)\n7. Subjects who are deemed ineligible for participation in the study by the investigator for reasons other than the above inclusion\u002Fexclusion criteria etc.","64 Years",{"count":147,"type":22},72,[25],"Phase 1 Safety and Relative Bioavailability Study of DWRX5003 in Healthy Adults",[151,152],"Obesity & Overweight","Type 2 Diabetes","2026-04-13",{"date":155,"type":33},"2026-04-20",{"date":157,"type":22},"2026-03-30",{"date":159,"type":22},"2026-08-30",{"name":39,"class":40},{"id":162,"slug":163,"hasResults":11,"nctId":164,"briefTitle":165,"officialTitle":166,"acronym":4,"eligibilityCriteria":167,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":168,"targetDuration":4,"studyType":23,"phases":170,"briefSummary":172,"conditions":173,"keywords":177,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":182,"lastUpdatePostDateStruct":183,"startDateStruct":185,"completionDateStruct":186,"leadSponsor":188,"locationsCount":41},"100632691","noseguard-for-prevention-of-respiratory-infections-in-real-world-use-100632691","NCT07516977","Noseguard for Prevention of Respiratory Infections in Real-World Use","A Clinical Study to Evaluate the Effectiveness of Combined Use of Two Nasal Protective Medical Devices (Noseguard and Noseguard Night) for Reducing Respiratory Infection Rates and Assessing Usability","Inclusion Criteria:\n\n* Adults aged ≥19 years\n* Able to provide informed consent\n\nExclusion Criteria:\n\n* Hypersensitivity to device components\n* Current COVID-19 or influenza infection\n* Severe nasal disease\n* Pregnant or breastfeeding women",{"count":169,"type":22},2000,[171],"NA","This study is a prospective clinical study to evaluate the effectiveness of combined use of two nasal protective medical devices (Noseguard and Noseguard Night) in reducing respiratory infection rates, including COVID-19 and influenza, in real-world conditions.\n\nThe study will also assess usability, satisfaction, and safety using electronic patient-reported outcomes (ePRO).",[174,175,176],"Respiratory Infection Virus","COVID-19","Influenza",[178,179,180,181,108],"Nasal Spray","Medical Device","Infection prevention","ePRO","2026-04-01",{"date":184,"type":33},"2026-04-08",{"date":155,"type":22},{"date":187,"type":22},"2026-12-31",{"name":39,"class":40},{"id":190,"slug":191,"hasResults":11,"nctId":192,"briefTitle":193,"officialTitle":194,"acronym":4,"eligibilityCriteria":195,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":196,"targetDuration":4,"studyType":99,"phases":4,"briefSummary":198,"conditions":199,"keywords":201,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":207,"lastUpdatePostDateStruct":208,"startDateStruct":210,"completionDateStruct":211,"leadSponsor":212,"locationsCount":41},"100632582","efficacy-and-safety-of-baroezet-tablet-in-korean-patients-with-dyslipidemia-a-prospective-observational-study-100632582","NCT07515560","Efficacy and Safety of Baroezet Tablet in Korean Patients With Dyslipidemia: A Prospective Observational Study","A Prospective, Non-interventional, Multi-center Observational Study to Evaluate the Efficacy and Safety of Baroezet Tablet 1\u002F10 mg in Korean Patients With Dyslipidemia","Inclusion Criteria:\n\n* Adults aged ≥19 years\n* Patients diagnosed with dyslipidemia\n* Patients who require treatment with Baroezet Tablet\n* Patients who provide written informed consent\n\nExclusion Criteria:\n\n* Hypersensitivity to study drug components\n* Active liver disease\n* Pregnant or breastfeeding women\n* Patients considered inappropriate by investigator",{"count":197,"type":22},12000,"This study is a prospective, non-interventional, multi-center observational study to evaluate the efficacy and safety of Baroezet Tablet 1\u002F10 mg in Korean patients with dyslipidemia in real-world clinical practice.\n\nPatients who are prescribed Baroezet Tablet according to the physician's clinical judgment will be followed for approximately 24 weeks. The study will assess changes in lipid profiles, including LDL-C, as well as safety outcomes such as adverse events.",[200],"Dyslipidemia",[200,202,203,204,205,206],"LDL-C","Statin","Ezetimibe","Observational Study","Real-world","2026-03-31",{"date":209,"type":33},"2026-04-07",{"date":112,"type":22},{"date":115,"type":22},{"name":39,"class":40},{"id":214,"slug":215,"hasResults":11,"nctId":216,"briefTitle":217,"officialTitle":218,"acronym":4,"eligibilityCriteria":219,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":220,"targetDuration":4,"studyType":99,"phases":4,"briefSummary":221,"conditions":222,"keywords":224,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":207,"lastUpdatePostDateStruct":226,"startDateStruct":227,"completionDateStruct":229,"leadSponsor":231,"locationsCount":41},"100632585","observational-study-to-evaluate-the-efficacy-of-olmetec-tab-on-nocturnal-blood-pressure-control-in-patients-with-stage--hypertension-100632585","NCT07515599","Observational Study to Evaluate the Efficacy of OLMETEC Tab on Nocturnal Blood Pressure Control in Patients With Stage Ⅰ Hypertension","A Prospective, Multi-Center, Observational Study to Evaluate the Efficacy of OLMETEC Tab. (or OLMETEC Plus Tab.) on Nocturnal Blood Pressure Control in Korean Patients With Stage Ⅰ Hypertension","Inclusion Criteria:\n\n* Adults aged ≥19 years\n* Patients diagnosed with stage 1 hypertension according to clinical guidelines\n* Patients who are newly prescribed Olmetec® or Olmetec Plus® in routine -clinical practice\n* Patients who are able to undergo ambulatory blood pressure monitoring (ABPM)\n* Patients who voluntarily agree to participate and provide written informed consent\n\nExclusion Criteria:\n\n* Patients with secondary hypertension\n* Patients with severe hypertension requiring immediate pharmacological i-ntervention\n* Patients with known hypersensitivity to olmesartan medoxomil, hydrochlorothiazide, or any component of the study drugs\n* Patients who are pregnant, planning to become pregnant, or breastfeeding\n* Patients with severe renal impairment or severe hepatic impairment\n* Patients who are unable to comply with study procedures, including ABPM\n* Patients who are deemed inappropriate for participation by the investigator",{"count":197,"type":22},"This is a prospective, multicenter, observational study to evaluate the effectiveness of Olmetec® or Olmetec Plus® on nocturnal blood pressure control in Korean patients with stage 1 hypertension. Patients receiving Olmetec-based therapy in routine clinical practice will be followed to assess changes in ambulatory blood pressure, including nocturnal blood pressure and blood pressure variability.",[223],"Stage 1 Hypertension",[225],"hypertension",{"date":209,"type":33},{"date":228,"type":33},"2025-09-17",{"date":230,"type":22},"2027-01-31",{"name":39,"class":40},{"id":233,"slug":234,"hasResults":11,"nctId":235,"briefTitle":236,"officialTitle":237,"acronym":4,"eligibilityCriteria":238,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":239,"targetDuration":4,"studyType":23,"phases":240,"briefSummary":241,"conditions":242,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":244,"lastUpdatePostDateStruct":245,"startDateStruct":247,"completionDateStruct":249,"leadSponsor":251,"locationsCount":41},"100612997","phase-1-bioequivalence-study-for-the-safety-and-the-pharmacokinetics-of-dwj1622-dwc202313-and-dwc202314-in-healthy-volunteers-under-fasting-conditions-100612997","NCT07260851","Bioequivalence Study for the Safety and the Pharmacokinetics of DWJ1622, DWC202313, and DWC202314 in Healthy Volunteers Under Fasting Conditions","An Open-label, Randomized, Fasting, Single-dose, 2-sequence, 2-period, Crossover Phase 1 Study to Evaluate the Pharmacokinetics and the Safety After Administration of \"DWJ1622\" and Co-administration of \"DWC202313\" and \"DWC202314\" in Healthy Volunteers","Inclusion Criteria:\n\n* Over 19 year old\n* Healthy adult volunteers\n\nExclusion Criteria:\n\n* with a history of mental disorder\n* For female volunteers, those who are suspected of being pregnant or lactating",{"count":76,"type":22},[25],"This study aims to evaluate the safety and pharmacokinetic characteristics of DWJ1622, DWC202313, and DWC202314 in healthy adult volunteers under fasting conditions.",[243],"Healthy Volunteers","2025-12-09",{"date":246,"type":33},"2025-12-17",{"date":248,"type":33},"2025-11-05",{"date":250,"type":22},"2026-05-30",{"name":39,"class":40},{"id":253,"slug":254,"hasResults":11,"nctId":255,"briefTitle":256,"officialTitle":257,"acronym":4,"eligibilityCriteria":238,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":258,"targetDuration":4,"studyType":23,"phases":260,"briefSummary":261,"conditions":262,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":263,"lastUpdatePostDateStruct":264,"startDateStruct":266,"completionDateStruct":268,"leadSponsor":269,"locationsCount":41},"100613486","phase-1-bioequivalence-study-for-the-safety-and-the-pharmacokinetics-of-dwc202313-dwc202314-and-dwj1622-in-healthy-volunteers-under-fed-condition-100613486","NCT07267221","Bioequivalence Study for the Safety and the Pharmacokinetics of DWC202313, DWC202314, and DWJ1622 in Healthy Volunteers Under Fed Condition.","An Open-label, Randomized, Fed, Single-dose, 2-sequence, 2-period, Crossover Phase 1 Study to Evaluate the Pharmacokinetics and the Safety After Administration of \"DWJ1622\" and Co-administration of \"DWC202313\" and \"DWC202314\" in Healthy Volunteers",{"count":259,"type":22},36,[25],"This study aims to evaluate the safety and pharmacokinetic characteristics of DWJ1622, DWC202313, and DWC202314 in healthy adult volunteers under fed conditions.",[243],"2025-12-03",{"date":265,"type":33},"2025-12-05",{"date":267,"type":22},"2025-12-01",{"date":250,"type":22},{"name":39,"class":40},{"id":271,"slug":272,"hasResults":11,"nctId":273,"briefTitle":274,"officialTitle":275,"acronym":4,"eligibilityCriteria":276,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":277,"targetDuration":4,"studyType":99,"phases":4,"briefSummary":279,"conditions":280,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":228,"lastUpdatePostDateStruct":282,"startDateStruct":284,"completionDateStruct":286,"leadSponsor":288,"locationsCount":4},"100607579","phase-4-multicenter-open-label-study-on-efficacy-and-safety-of-apremilast-in-moderate-to-severe-psoriasis-100607579","NCT07190391","Phase 4 Multicenter, Open-label Study on Efficacy and Safety of Apremilast in Moderate-to-severe Psoriasis","A Multi-center, Single-arm, Open-label, Phase 4 Clinical Study to Evaluate the Efficacy and Safety of Apremilast in Patients With Moderate-to-severe Psoriasis","Inclusion Criteria:\n\n* Male or female patients aged ≥19 years at the time of enrollment.\n* Patients with moderate to severe psoriasis persisting for ≥6 months.\n* Patients with a PASI (Psoriasis Area and Severity Index) score between 5 and 10, requiring pharmacological treatment.\n* Patients who have been fully informed about the study, have understood the explanation, and have voluntarily signed the informed consent form.\n* Patients who are considered cooperative and able to participate until the end of the study.\n\nExclusion Criteria:\n\n* Patients with a history of hypersensitivity to apremilast.\n* Patients with genetic disorders such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.\n* Pregnant or breastfeeding women.\n* Patients (or their spouse\u002Fpartner) who do not agree to use medically acceptable and appropriate methods of contraception\\* during the study period.\n\n  \\* Medically acceptable and appropriate methods of contraception include: hormonal contraception (implants, injectables, oral contraceptives, etc.), intrauterine devices (copper IUD, hormone-releasing intrauterine system), salpingectomy, tubal ligation, hysterectomy, vasectomy, dual barrier methods (male condom and female condom, cervical cap, diaphragm, contraceptive sponge used in combination), or single barrier method combined with spermicide.\n* Patients receiving strong CYP3A4 enzyme inducers (e.g., rifampicin, phenobarbital, carbamazepine, phenytoin, St. John's Wort).\n* Patients with severe renal impairment requiring hemodialysis or peritoneal dialysis.\n* Patients who have previously received Apremilast (ApsoLla®) prior to enrollment, or those currently participating in another clinical trial involving an investigational medicinal product or medical device.\n\n(However, patients enrolled in non-interventional studies or who have completed participation in another clinical trial are eligible.)\n\n* Patients with a history of psychiatric disorders (e.g., substance abuse, depression).\n* Patients who, in the opinion of the investigator, are otherwise considered unsuitable for participation in this study.",{"count":278,"type":22},425,"This study aims to evaluate the efficacy and safety of Apremilast tablets in patients with psoriasis over 32 weeks, through a multicenter, single-arm, open-label, phase 4 clinical trial.",[281],"Psoriasis",{"date":283,"type":33},"2025-09-24",{"date":285,"type":22},"2025-09-30",{"date":287,"type":22},"2027-10-31",{"name":39,"class":40},{"id":290,"slug":291,"hasResults":11,"nctId":292,"briefTitle":293,"officialTitle":294,"acronym":4,"eligibilityCriteria":295,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":145,"enrollmentInfo":296,"targetDuration":4,"studyType":23,"phases":298,"briefSummary":293,"conditions":299,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":301,"lastUpdatePostDateStruct":302,"startDateStruct":304,"completionDateStruct":306,"leadSponsor":307,"locationsCount":41},"100604027","phase-1-pk-and-safety-comparison-of-dwj1511-and-dwc202501-in-healthy-volunteers-100604027","NCT07144176","PK and Safety Comparison of DWJ1511 and DWC202501 in Healthy Volunteers","An Open-label, Randomized, Fasting, Single-dose, Two-treatment, Two-period, Crossover, Phase 1 Clinical Trial to Compare and Evaluate the Pharmacokinetics and Safety of \"DWJ1511\" and \"DWC202501\" in Healthy Adult Volunteers","Inclusion Criteria:\n\n* Male or female participants aged ≥19 years and \\\u003C65 years at the time of screening\n* Body mass index (BMI) between 18 and 30 kg\u002Fm² (BMI = weight \\[kg\\] \u002F height \\[m\\]²)\n\nExclusion Criteria:\n\n* Subjects who have participated in a bioequivalence study or any other clinical trial and have received an investigational product within 6 months prior to the first administration.\n* Subjects who have donated whole blood within 8 weeks prior to the first administration, donated blood components within 2 weeks prior to the first administration, or received a blood transfusion within 4 weeks prior to the first administration.\n* Subjects with a history of gastrointestinal surgery that may affect drug absorption (appendectomy and hernia repair are not exclusionary).",{"count":297,"type":22},60,[25],[300],"Healthy Subjects","2025-08-27",{"date":303,"type":33},"2025-08-28",{"date":305,"type":22},"2025-09",{"date":305,"type":22},{"name":39,"class":40},{"id":309,"slug":310,"hasResults":11,"nctId":311,"briefTitle":312,"officialTitle":313,"acronym":4,"eligibilityCriteria":314,"healthyVolunteers":11,"sex":17,"minAge":315,"maxAge":4,"enrollmentInfo":316,"targetDuration":4,"studyType":23,"phases":318,"briefSummary":320,"conditions":321,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":323,"lastUpdatePostDateStruct":324,"startDateStruct":326,"completionDateStruct":328,"leadSponsor":330,"locationsCount":331},"100469162","phase-2-clinical-trial-to-evaluate-the-safety-and-efficacy-of-dwn12088-in-patients-with-ipf-100469162","NCT05389215","Clinical Trial to Evaluate the Safety and Efficacy of DWN12088 in Patients With IPF","A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of DWN12088 in Patients With Idiopathic Pulmonary Fibrosis","Inclusion Criteria:\n\n* Male or female patients aged ≥40 years based on the date of the written informed consent form\n* Diagnosis of IPF as defined by American Thoracic Society\u002FEuropean Respiratory Society\u002FJapanese Respiratory Society\u002FLatin American Thoracic Association guidelines\n* In a stable condition and suitable for study participation based on the results of medical history, physical examination, vital signs, 12-lead ECG, and laboratory evaluation\n* Patients receiving local standard-of-care for IPF, defined as either pirfenidone or nintedanib, at a stable dose for at least 3 months prior to screening, or neither pirfenidone nor nintedanib. If the patients were on pirfenidone or nintedanib previously and have been off for at least 3 months prior to screening, they will be considered as not on any treatment for IPF\n* Meeting all of the following criteria during the screening period:\n\n  * FVC ≥40% predicted of normal\n  * DLCO corrected for Hgb ≥25% and ≤80% predicted of normal.\n  * forced expiratory volume in the first second\u002FFVC (FEV1\u002FFVC) ratio ≥0.7 based on pre-bronchodilator value\n\nExclusion Criteria:\n\n* Acute IPF exacerbation within 6 months prior to screening and\u002For during the screening period\n* Patients who are unwilling to refrain from smoking within 3 months prior to screening and until the end of the study\n* Female patients who are pregnant or nursing\n* Abnormal ECG findings\n* Use of any investigational drugs for IPF within 4 weeks prior to screening","40 Years",{"count":317,"type":22},102,[319],"PHASE2","This is a randomized, double-blinded, placebo-controlled multicenter study to evaluate the safety and efficacy of DWN12088 in patients with Idiopathic Pulmonary Fibrosis.",[322],"Idiopathic Pulmonary Fibrosis","2025-07-31",{"date":325,"type":33},"2025-08-05",{"date":327,"type":33},"2022-07-29",{"date":329,"type":22},"2027-01-30",{"name":39,"class":40},30,{"id":333,"slug":334,"hasResults":11,"nctId":335,"briefTitle":336,"officialTitle":337,"acronym":4,"eligibilityCriteria":338,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":339,"enrollmentInfo":340,"targetDuration":4,"studyType":99,"phases":4,"briefSummary":341,"conditions":342,"keywords":344,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":347,"lastUpdatePostDateStruct":348,"startDateStruct":350,"completionDateStruct":352,"leadSponsor":354,"locationsCount":41},"100588982","efficacy-and-safety-of-fexuclue-tab-in-patients-with-acute-or-chronic-gastritis-100588982","NCT06948487","Efficacy and Safety of FEXUCLUE Tab. In Patients With Acute or Chronic Gastritis","A Prospective, Multi-center, Observational Study on the Efficacy and Safety of FEXUCLUE Tab. In Patients With Acute or Chronic Gastritis","Inclusion Criteria:\n\n* Adult subjects between the ages of 19 and 75 years at the time of obtaining written informed consent.\n* Subjects who are scheduled to receive Fexuclu tablets (fexuprazan) in accordance with the approved indication.\n* Subjects who present with at least one subjective symptom requiring medical treatment\n* Subjects who are capable of understanding the information provided, have voluntarily decided to participate in this observational study, and have provided written informed consent for the use of their personal data.\n\nExclusion Criteria:\n\n* Individuals who fall under any contraindications for the administration of Fexuclu tablets (fexuprazan) as specified in the approved labeling.\n* Individuals who are deemed by the investigator (attending physician) to be inappropriate for participation in this observational study for any reason not otherwise specified.","75 Years",{"count":197,"type":22},"This study aims to evaluate the efficacy of Fexuclue tablets in improving gastrointestinal symptoms based on patient-reported outcomes (PROs), by comparing assessments before and after treatment.",[343],"Gastritis",[345,346],"Acute","Chronic","2025-07-14",{"date":349,"type":33},"2025-07-17",{"date":351,"type":33},"2025-06-17",{"date":353,"type":22},"2027-06-03",{"name":39,"class":40},{"id":356,"slug":357,"hasResults":11,"nctId":358,"briefTitle":359,"officialTitle":360,"acronym":4,"eligibilityCriteria":361,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":362,"enrollmentInfo":363,"targetDuration":4,"studyType":23,"phases":365,"briefSummary":366,"conditions":367,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":369,"lastUpdatePostDateStruct":370,"startDateStruct":372,"completionDateStruct":374,"leadSponsor":375,"locationsCount":41},"100593964","phase-3-evaluate-the-efficacy-and-safety-of-dwp712-with-moderate-to-severe-glabellar-lines-100593964","NCT07013279","Evaluate the Efficacy and Safety of DWP712 With Moderate to Severe Glabellar Lines","A Double-blind, Randomized, Active-controlled, Multi-center, Phase III Study to Evaluate the Efficacy and Safety of DWP712 Inj. in Subjects With Moderate to Severe Glabellar Lines","Inclusion Criteria:\n\n\\- Subjects with a facial wrinkle scale (FWS) score of ≥2 (moderate) for glabellar lines at maximum frown in the investigator's on-site assessment at screening\n\nExclusion Criteria:\n\n\\- Subjects with glabellar lines that cannot sufficiently be improved by physical attempts, e.g., glabellar lines not flattened by hand, in the judgment of the investigator","65 Years",{"count":364,"type":22},324,[54],"To evaluate the efficacy and safety of DWP712 Inj. in Subjects with Moderate to Severe Glabellar Lines",[368],"Glabellar Lines","2025-06-02",{"date":371,"type":33},"2025-06-10",{"date":373,"type":22},"2025-07-15",{"date":207,"type":22},{"name":39,"class":40},{"id":377,"slug":378,"hasResults":11,"nctId":379,"briefTitle":380,"officialTitle":381,"acronym":4,"eligibilityCriteria":382,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":383,"targetDuration":4,"studyType":99,"phases":4,"briefSummary":384,"conditions":385,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":387,"lastUpdatePostDateStruct":388,"startDateStruct":390,"completionDateStruct":392,"leadSponsor":394,"locationsCount":41},"100565877","evaluation-of-enavogliflozins-efficacy-and-safety-in-type-ii-diabetes-with-hypertension-or-dyslipidemia-100565877","NCT06647888","Evaluation of Enavogliflozin's Efficacy and Safety in Type II Diabetes With Hypertension or Dyslipidemia","A Multi-Center, Observational Study to Evaluate the Efficacy and Safety of Enavogliflozin in Patients With Type II Diabetes Mellitus Accompanied by Hypertension or Dyslipidemia","Inclusion Criteria:\n\n1. An adult male and female over 19 years of age\n2. A patient diagnosed with type 2 diabetes who have hypertension or dyslipidemia and are currently receiving Envlo Tab\u002F Envlomet SR Tab or are scheduled to receive Envlo Tab\u002F Envlomet SR Tab\n3. A person who voluntarily participates in the observational study and agrees in writing to comply with the subject's precautions during the study period after hearing and understanding the detailed explanation of the characteristics of the observational study and the drug to be studied 4 ) A person who understands the content of this observational study, are cooperative with the research process, and are considered capable of participating until the study's completion\n\nExclusion Criteria:\n\n1. Among patients who begin treatment with Envlo Tab\u002F Envlomet Tab at the time of registration, those with an estimated glomerular filtration rate (eGFR) of less than 60 ml\u002Fmin\u002F1.73m²\n2. A patient with diabetes other than type 2 diabetes (type 1 diabetes, diabetic ketoacidosis, gestational diabetes, etc.)\n3. A person who is prohibited from administering in accordance with the permission of Envlo Tab's\n\n   * Patients who overreact to Envlo Tab or Envlomet Tab components and have a history of it\n   * Patients with an estimated glomerular filtration rate (eGFR) of less than 60 ml\u002Fmin\u002F1.73m², end-stage renal disease, or on dialysis\n   * Patients with moderate and severe liver failure (AST or ALT \\> 3x normal upper limit, Total Bilirubin \\> 2x normal upper limit, hepatitis or liver failure)\n   * Class III or IV by classification of the New York Heart Association (NYHA)\n4. Patients with unstable weight due to treatment or other treatments (surgery, diet, etc.) with obesity or weight loss medication within 3 months of Enrollment\n5. Pregnant women and lactating women\n6. A person who participates in another clinical trial and is administering (applying) clinical trial drugs or clinical trial medical devices\n7. A person who is considered inappropriate to participate in this observational study based on the judgment of investigators",{"count":197,"type":22},"This observational study is a non-interventional, multi-center, prospective observational study aimed at tracking the efficacy and safety of Envlo or Envlomet SR tablets for 24 weeks in patients with type 2 diabetes and hypertension or dyslipidemia who are currently taking or are scheduled to take Envlo or Envlomet SR tablets in an actual clinical setting.",[386],"Diabetes Mellitus, Type 2","2025-01-21",{"date":389,"type":33},"2025-01-23",{"date":391,"type":33},"2024-12-03",{"date":393,"type":22},"2026-06-30",{"name":39,"class":40},{"id":396,"slug":397,"hasResults":11,"nctId":398,"briefTitle":399,"officialTitle":400,"acronym":401,"eligibilityCriteria":402,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":403,"enrollmentInfo":404,"targetDuration":4,"studyType":23,"phases":406,"briefSummary":407,"conditions":408,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":410,"lastUpdatePostDateStruct":411,"startDateStruct":413,"completionDateStruct":415,"leadSponsor":417,"locationsCount":41},"100565609","phase-1-phase-1-study-of-drug-drug-interactions-between-dwp16001-dwc202407-and-dwc202408-in-healthy-adults-100565609","NCT06644404","Phase 1 Study of Drug-Drug Interactions Between DWP16001, DWC202407, and DWC202408 in Healthy Adults","A Randomized, Open, Two-sequence, Crossover, Multiple Oral Administrations, Phase 1 Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetic\u002FPharmacodynamic Drug-drug Interaction Between DWP16001, DWC202407, and DWC202408 in Healthy Adults","DW_DWP16001112","Inclusion Criteria:\n\n1. Healthy adult volunteers aged 19 to 50 years at the time of screening.\n2. Individuals with a body weight between 50.0 kg and 90.0 kg and a Body Mass Index (BMI) between 18.5 kg\u002Fm² and 29.9 kg\u002Fm² at the time of screening.\n3. Female volunteers must be neither pregnant nor breastfeeding, or must be in a surgically sterile state (e.g., bilateral tubal occlusion, hysterectomy, bilateral salpingectomy, bilateral oophorectomy).\n4. Individuals who have been fully informed about the clinical trial, have fully understood the details, voluntarily decided to participate, and provided written consent to comply with the precautions.","50 Years",{"count":405,"type":22},34,[25],"This study aims to evaluate the pharmacokinetic\u002Fpharmacodynamic drug-drug interactions between DWP16001, DWC202407, and DWC202408 in healthy adults",[409],"Healthy","2024-10-14",{"date":412,"type":33},"2024-10-16",{"date":414,"type":22},"2024-10-26",{"date":416,"type":22},"2025-04-01",{"name":39,"class":40},{"id":419,"slug":420,"hasResults":11,"nctId":421,"briefTitle":422,"officialTitle":423,"acronym":4,"eligibilityCriteria":238,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":424,"targetDuration":4,"studyType":23,"phases":426,"briefSummary":427,"conditions":428,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":429,"lastUpdatePostDateStruct":430,"startDateStruct":432,"completionDateStruct":434,"leadSponsor":436,"locationsCount":4},"100561617","phase-1-bioepuivalence-study-for-the-safety-and-the-pharmacokinetics-of-dwj1589-and-dwc202315-100561617","NCT06592495","Bioepuivalence Study for the Safety and the Pharmacokinetics of DWJ1589 and DWC202315","Bioepuivalence Study for the Safety and the Pharmacokinetics of DWJ1589 and DWC202315 in Healthy Adult Volunteers Under Fasting Conditions",{"count":425,"type":22},52,[25],"This study aims to evaluate the safety and pharmacokinetic characteristics after administration of DWJ1589 and DWC202315 in healty adult volunteers.",[243],"2024-09-19",{"date":431,"type":33},"2024-09-23",{"date":433,"type":22},"2024-10",{"date":435,"type":22},"2025-10",{"name":39,"class":40},{"id":438,"slug":439,"hasResults":11,"nctId":440,"briefTitle":441,"officialTitle":442,"acronym":4,"eligibilityCriteria":443,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":444,"targetDuration":4,"studyType":23,"phases":446,"briefSummary":447,"conditions":448,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":450,"lastUpdatePostDateStruct":451,"startDateStruct":453,"completionDateStruct":454,"leadSponsor":455,"locationsCount":41},"100562663","phase-3-evaluate-the-efficacy-and-safety-of-dwp16001-in-type-2-diabetic-nephropathy-with-moderate-renal-impairment-patients-100562663","NCT06606093","Evaluate the Efficacy and Safety of DWP16001 in Type 2 Diabetic Nephropathy with Moderate Renal Impairment Patients","A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multi-center, Phase 3 Clinical Trial and Open-label Extension Clinical Trial to Evaluate the Efficacy and Safety of DWP16001 in Type 2 Diabetic Nephropathy with Moderate Renal Impairment Patients (CKD Stage 3)","Inclusion Criteria:\n\n1. Men and women aged 19 years or older as of the date of written consent.\n2. Patients with type 2 diabetes who have been on up to 3 antidiabetic medications at a stable dosage and regimen for at least 8 weeks prior to the Pre-Baseline Visit (Visit 1-1). For insulin, a fluctuation of within 10% during the 8 weeks prior to the Pre-Baseline Visit (Visit 1-1) is allowed.\n3. Patients with a BMI of 18 to 45 kg\u002Fm² at the Screening Visit (Visit 1).\n4. Patients whose test results from the investigational site\\'s laboratory at the Screening Visit (Visit 1) meet all of the following criteria:\n\n   * HbA1c: 7.0% ≤ HbA1c ≤ 10.0%\n   * eGFR: 30 ≤ eGFR \\< 60 ml\u002Fmin\u002F1.73 m² (using the CKD-EPI formula)\n5. Patients who are willing to cooperate and participate in this clinical trial after understanding the explanation of the trial and who can voluntarily sign the informed consent form.\n6. Patients whose central laboratory results from the sample collected at the Pre-Baseline Visit (Visit 1-1) show an eGFR of 30 ≤ eGFR \\< 60 ml\u002Fmin\u002F1.73 m² (using the CKD-EPI formula).\n7. Patients whose central laboratory results from the sample collected at the Pre-Baseline Visit (Visit 1-1) show an HbA1c of 7.0% ≤ HbA1c ≤ 10.0%.\n8. Patients with a medication compliance rate of 70-130% during the Run-in Period, as confirmed at the Baseline Visit (Visit 2).\n\nExclusion Criteria:\n\n1. Individuals diagnosed with renal diseases other than diabetic chronic kidney disease\n2. Patients with uncontrolled hypertension (SBP ≥ 180 mmHg or DBP ≥ 110 mmHg)\n3. Individuals diagnosed with type 1 diabetes (insulin-dependent diabetes) or diabetic ketoacidosis\n4. Individuals who are undergoing dialysis at the time of the Screening Visit (Visit 1) or have a history of renal transplantation or medically significant renal disease\u002Fsurgery (e.g., renal vascular occlusive disease, nephrectomy)\n5. Individuals who have received cytotoxic treatment, immunosuppressive therapy, or immunotherapy for renal disease within 6 months of the Baseline Visit (Visit 2)\n6. Individuals diagnosed with or treated for any of the following diseases within 3 months of the Screening Visit (Visit 1), as determined by the investigator to be clinically significant:\n\n   * Severe heart disease \\[heart failure (NYHA class III and IV), ischemic heart disease (angina, myocardial infarction), peripheral vascular disease, individuals who have undergone percutaneous transluminal coronary angioplasty or coronary artery bypass grafting\\]\n\n     \\* NYHA class:\n     * Class I: No limitation on physical activity; no symptoms during ordinary activities\n     * Class II: Slight limitation on physical activity; no symptoms at rest, but symptoms occur during ordinary activities\n     * Class III: Marked limitation on physical activity; no symptoms at rest, but symptoms occur with less than ordinary activities\n     * Class IV: Symptoms present even at rest, and worsened by any physical activity\n   * Hypertrophic obstructive cardiomyopathy, severe obstructive coronary artery disease, aortic stenosis, hemodynamically significant aortic or mitral valve stenosis\n   * Clinically significant ventricular tachycardia, atrial fibrillation, atrial flutter, arrhythmia\n   * Transient ischemic attack\n   * Severe cerebrovascular diseases (e.g., stroke, cerebral infarction, cerebral hemorrhage)\n7. Individuals requiring treatment due to dehydration from continuous diarrhea or vomiting, or those at risk of fluid volume depletion\n8. Individuals unable to take medications orally, or with major gastrointestinal diseases or surgeries (e.g., gastrectomy, gastrointestinal bypass) that may affect drug absorption, distribution, metabolism, or excretion\n9. Individuals with positive results from the serology tests at the Screening Visit (Visit 1):\n\n   * Positive for HIV\n   * Positive for HBsAg with HBV DNA ≥ 2000 IU\u002FmL\n   * Positive for Anti-HCV\n10. Individuals with severe liver dysfunction at the Screening Visit (Visit 1) as follows:\n\n    * AST or ALT \\> 3 times the upper limit of normal\n    * Total bilirubin \\> 2 times the upper limit of normal\n11. Individuals with more than a 25% change in eGFR between the Screening Visit (Visit 1) and the Baseline Visit (Visit 2)\n12. Individuals with clinically significant severe infections (e.g., those requiring continuous antibiotic or immunotherapy) or severe trauma, as determined by the investigator\n13. Individuals with a past or present diagnosis of malignant tumors (participation allowed if cured or if there has been no recurrence in the past 5 years)\n14. Individuals with a history of hypersensitivity to the active ingredient or components of the investigational drug\n15. Individuals with a history of alcohol or drug abuse within 12 months of the Screening Visit (Visit 1)\n16. Individuals taking ACE inhibitors, ARBs, or renin inhibitors (allowed if taken at a stable dose and regimen for more than 8 weeks prior to the Pre-Baseline Visit (Visit 1-1))\n17. Individuals requiring continuous systemic corticosteroid treatment (use of topical corticosteroids for joint, nasal, ocular, or inhalation administration, or temporary systemic corticosteroid use for contrast agent allergies or adverse event treatment\u002Fprevention is allowed)\n18. Women of childbearing potential who do not agree to use appropriate contraception\\* during the trial A. Women over 50 years of age who have been amenorrheic for at least 12 months after discontinuing exogenous hormone therapy B. Women with a history of irreversible surgical infertility (e.g., hysterectomy, bilateral oophorectomy, or bilateral salpingectomy) (tubal ligation not allowed) C. Women under 50 years of age who have been amenorrheic for at least 12 months after discontinuing exogenous hormone therapy and whose luteinizing hormone (LH) and follicle-stimulating hormone (FSH) levels are within postmenopausal ranges according to the investigational site\\'s standards Appropriate contraception: Complete abstinence, tubal ligation, hormonal contraceptives with no known drug interactions \\[levonorgestrel intrauterine system (IUS) (Mirena), medroxyprogesterone injection\\], copper intrauterine devices, and partner's vasectomy. Periodic abstinence (e.g., calendar methods, basal body temperature method, or post-ovulation method) and withdrawal are not considered acceptable contraceptive methods.\n19. Men who have not undergone vasectomy and who do not agree to use barrier contraception (e.g., condoms), or whose partners do not agree to use appropriate contraception during the trial\n20. Pregnant or breastfeeding women, or women with a positive pregnancy test result at the Screening Visit (Visit 1) or Baseline Visit (Visit 2)\n21. Individuals who received investigational drugs within 8 weeks prior to the Screening Visit (Visit 1) (participation allowed if no investigational drug was administered or if involved in a non-interventional observational study)\n22. Other individuals deemed inappropriate for trial participation at the discretion of the investigator",{"count":445,"type":22},348,[54],"This study aims to evaluate the efficacy and safety of DWP16001 in type 2 diabetic nephropathy with moderate renal impairment patients (CKD stage 3)",[449],"Type 2 Diabetic Nephropathy","2024-09-18",{"date":452,"type":33},"2024-09-20",{"date":431,"type":22},{"date":230,"type":22},{"name":39,"class":40},""]