[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Haiphong University of Medicine and Pharmacy\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":213},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,51,90,125,161,194],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":15,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100642949","a-single-center-randomized-double-blind-placebo-controlled-intervention-clinical-trial-to-evaluate-the-efficacy-and-safety-of-koreaginseng-f-max-on-blood-circulation-improvement-in-adults-with-poor-peripheral-blood-flow-100642949",false,"NCT07643532","A Single-center, Randomized, Double-blind, Placebo-controlled, Intervention Clinical Trial to Evaluate the Efficacy and Safety of \"KoreaGinseng F Max\" on Blood Circulation Improvement in Adults With Poor Peripheral Blood Flow","Inclusion Criteria:\n\n* Men or women aged 20 to under 65 years\n* Platelet aggregation response above 55% (satisfied for both collagen and ADP)\n* Provides voluntary written informed consent to participate\n\nExclusion Criteria:\n\n* History of hypersensitivity or allergy to ginseng-containing products that may affect the results\n* Surgery under general anesthesia within 12 weeks before participation\n* Use of contraindicated products such as red ginseng or omega-3 fatty acids within 2 weeks before screening\n* Use of antiplatelet drugs such as aspirin within 2 weeks before screening (subjects on prophylactic aspirin \\\u003C100 mg with unchanged dose\u002Fmethod may participate)\n* Uncontrolled hypertension not managed by medication (systolic BP \\>160 mmHg or diastolic BP \\>97 mmHg)\n* Currently using study-indicated medications such as those for dyslipidemia or diabetes\n* On drug treatment with a history of peripheral atherosclerosis and coronary artery disease (peripheral vascular disease, abdominal aortic aneurysm, carotid artery disease)\n* Coronary artery bypass surgery, vascular anastomosis, pacemaker use, myocardial infarction, heart failure, arrhythmia, or other cardiac disease within 6 months\n* Infectious inflammatory disease, systemic infection, immune-resistance-related disease, or leukemia (blood cancer)\n* Irritable bowel syndrome, gastrointestinal resection surgery, or GI-related disease such as Crohn's disease\n* History of cerebral ischemia or cerebral hemorrhage such as cerebral infarction or stroke due to atherosclerosis\n* Concurrent symptoms of myocardial infarction, atherosclerosis, or congestive heart failure\n* Clinically significant liver dysfunction (ALT or AST ≥2.5x the upper limit of normal)\n* Clinically significant renal dysfunction (serum creatinine \\>2.0 mg\u002FdL)\n* TSH outside 0.27-5.07 microIU\u002FmL or thyroid disease\n* History of, or current treatment for, psychiatric\u002Fneurological disorders including schizophrenia, depression, or drug addiction\n* History of malignant tumor within 5 years before screening\n* Pregnant or breastfeeding women, women of childbearing potential not using medically reliable contraception, or women within 6 months postpartum\n* Alcohol consumption within the last 3 days (men 30 g\u002Fday, women 20 g\u002Fday)\n* Participation in another clinical trial within 4 weeks before participation\n* Subjects judged unsuitable by the investigator or other physicians",true,"ALL","20 Years","65 Years",{"count":20,"type":21},100,"ESTIMATED","INTERVENTIONAL",[24],"NA","This is a single-center, randomized, double-blind, placebo-controlled clinical trial evaluating the efficacy and safety of a white ginseng extract (KoreaGinseng F Max) for improving blood circulation in adults with poor peripheral blood flow.\n\nA total of 100 adults aged 20 to under 65 years with platelet aggregation above 55% will be enrolled and randomly assigned in a 1:1 ratio to receive either the white ginseng extract or a matching placebo for 8 weeks. Each participant takes 3 tablets after breakfast and 3 tablets after dinner (6 tablets per day).\n\nThe main goal is to measure the change in ADP-induced platelet aggregation from baseline (Visit 2) to the end of treatment (Visit 4, Week 8). The study also assesses effects on coagulation measures, blood lipids, serotonin, blood pressure, white blood cell count, and overall safety.",[27,28,29],"Blood Circulation","Peripheral Blood Flow","Platelet Aggregation",[31,32,33,34,35,36,37],"White ginseng extract","KoreaGinseng F Max","Platelet aggregation","Blood circulation","Antiplatelet","Dietary supplement","Functional food","NOT_YET_RECRUITING","2026-06-08",{"date":41,"type":42},"2026-06-11","ACTUAL",{"date":44,"type":21},"2026-06-10",{"date":46,"type":21},"2028-06-10",{"name":48,"class":49},"Haiphong University of Medicine and Pharmacy","OTHER",1,{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":57,"eligibilityCriteria":58,"healthyVolunteers":11,"sex":16,"minAge":59,"maxAge":60,"enrollmentInfo":61,"targetDuration":4,"studyType":22,"phases":63,"briefSummary":64,"conditions":65,"keywords":69,"overallStatus":81,"whyStopped":4,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":50},"100604748","biolizin-for-improving-functional-poor-appetite-in-children-aged-6-to-36-months-ctbe2502-100604748","NCT07153549","Biolizin for Improving Functional Poor Appetite in Children Aged 6 to 36 Months (CTBE2502)","A Parallel-Group, Randomized, Open-Label, Controlled Study to Evaluate the Efficacy and Safety of a Zinc-Containing Dietary Supplement (Biolizin) in Improving Functional Poor Appetite in Children Aged 6 to 36 Months","CTBE2502","Inclusion Criteria:\n\n* Age 6 to 36 months at screening.\n* Functional poor appetite for ≥2 weeks with at least one of the following:\n\n  * Clearly reduced intake versus usual (lower amount of food and\u002For fewer meals per day);\n  * Prolonged meal duration (\\>30 minutes per meal);\n  * Refusal or avoidance of familiar foods previously accepted;\n  * Oppositional feeding behaviors (turning away, crying, gagging\u002Fretching, prolonged food holding, lack of cooperation during meals).\n* No obvious organic cause of poor appetite (e.g., acute infection, gastrointestinal\u002Fmetabolic disease).\n* Weight not below -2 SD compared with WHO growth standards.\n* Parent\u002Fguardian provides written informed consent.\n\nExclusion Criteria:\n\n* Ongoing acute or chronic illnesses that can affect intake or absorption, including but not limited to:\n\n  * Acute infections (e.g., tonsillitis, pneumonia, otitis media, viral febrile illness, acute diarrhea);\n  * Chronic conditions affecting digestion or metabolism (e.g., celiac disease, malabsorption syndromes, chronic liver disease, chronic kidney disease, diabetes).\n* Neurodevelopmental or neurological conditions that impair feeding (e.g., cerebral palsy, autism spectrum disorder, global developmental delay).\n* Current or recent use of medications known to alter appetite or digestion\u002Fabsorption (e.g., systemic corticosteroids, antiepileptics, prolonged antibiotics).\n* Use of zinc-containing products or other appetite stimulants within 7 days before screening.\n* Known hypersensitivity to any component of the study product.\n* Malabsorption, severe malnutrition, or requirement for specialized nutrition, including:\n\n  * Confirmed or suspected malabsorption (e.g., celiac disease, severe lactose intolerance, short bowel syndrome, inflammatory bowel disease);\n  * Severe malnutrition per WHO criteria (e.g., weight-for-length Z-score \\\u003C -3 SD, nutritional edema, marked loss of subcutaneous fat\u002Fmuscle);\n  * Physician-prescribed specialized nutrition plans (therapeutic formulas for cow's milk protein allergy, severe malnutrition, tube feeding, or individualized nutrition regimens beyond usual diet).\n* Nonadherent caregiver or high risk of loss to follow-up as judged by the investigator.","6 Months","36 Months",{"count":62,"type":21},110,[24],"Functional poor appetite is common in young children and may be linked to suboptimal micronutrient intake and feeding behavior. This study evaluates whether a zinc-containing oral supplement (Biolizin syrup) can improve eating behavior in children aged 6 to 36 months who have poor appetite without an identifiable medical cause. Participants are followed for 42 days with clinic visits at Day 0, Day 7, Day 21, and Day 42. Caregivers complete validated questionnaires about feeding difficulties and eating behavior; the child's weight and length\u002Fheight are measured at each visit. Safety is assessed through review of adverse events and routine laboratory tests; serum zinc may be measured according to the protocol. The primary outcome is the change from baseline to Day 42 in the total score of a validated feeding-difficulty scale. Secondary outcomes include changes in Children's Eating Behaviour Questionnaire (CEBQ) subscales, WHO growth indices, serum zinc (if measured), and overall safety",[66,67,68],"Feeding and Eating Disorders of Childhood","Appetite Disorders","Functional Poor Appetite",[70,71,72,73,74,75,76,77,78,79,80],"functional poor appetite","pediatric feeding problems","feeding difficulty","loss of appetite","eating\u002Ffeeding behavior","Children's Eating Behaviour Questionnaire","toddler","infants","zinc supplement","dietary supplement","Biolizin","RECRUITING","2026-01-28",{"date":84,"type":42},"2026-01-30",{"date":86,"type":42},"2025-09-20",{"date":88,"type":21},"2026-04-30",{"name":48,"class":49},{"id":91,"slug":92,"hasResults":11,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":96,"eligibilityCriteria":97,"healthyVolunteers":11,"sex":16,"minAge":98,"maxAge":99,"enrollmentInfo":100,"targetDuration":4,"studyType":22,"phases":101,"briefSummary":102,"conditions":103,"keywords":109,"overallStatus":81,"whyStopped":4,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":118,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":50},"100604366","bioamicus-complete-for-functional-gastrointestinal-symptoms-in-infants-aged-0-to-24-months-100604366","NCT07148583","BioAmicus Complete for Functional Gastrointestinal Symptoms in Infants Aged 0 to 24 Months","Evaluation of the Efficacy and Safety of the Multistrain Probiotic \"BioAmicus Complete\" in Improving Gastrointestinal Symptoms in Children Aged 0-24 Months: A Randomized, Open-Label, Parallel-Group, Controlled Trial","CTBE2503","Inclusion Criteria:\n\n* Age 0-24 months at enrollment.\n* Infant has clinician-assessed functional gastrointestinal symptoms (e.g., colic\u002Firritability, regurgitation, constipation, loose stools), judged suitable for study participation.\n* Parent or legal guardian provides written informed consent and agrees to comply with study procedures (questionnaires\u002Fdiaries and sample collection, if applicable).\n* Caregivers agree to avoid other probiotic products during the study period, except as directed by the study team.\n\nExclusion Criteria:\n\n* Major congenital gastrointestinal anomalies or known chronic gastrointestinal diseases requiring ongoing prescription therapy (e.g., Hirschsprung disease, inflammatory bowel disease, short-bowel syndrome).\n* Clinically unstable condition or severe\u002Fcritical illness that could interfere with participation or safety in the opinion of the investigator.\n* Known or suspected primary or secondary immunodeficiency, or current immunosuppressive therapy.\n* History of severe allergy or hypersensitivity to components of the investigational product.\n* Recent use of systemic antibiotics within 14 days prior to baseline, or use of probiotic supplements within 14 days prior to baseline (per protocol).\n* Participation in another interventional clinical trial within 30 days prior to enrollment or during the study.\n* Any condition that, in the investigator's judgment, would make the participant unsuitable for the study or confound outcome assessments.","0 Days","24 Months",{"count":62,"type":21},[24],"Infants often experience functional gastrointestinal symptoms (e.g., colic, excessive gas, regurgitation, constipation, or loose stools) that distress families and may reflect an imbalance of the gut microbiome. This study evaluates whether the multistrain probiotic BioAmicus Complete can improve caregiver-reported gastrointestinal symptoms in infants 0-24 months and is safe for use in this population.\n\nThe primary assessment is the change in the Infant Gastrointestinal Symptom Questionnaire (IGSQ) total score from the start to the end of the study period. Secondary assessments include symptom domains (colic\u002Fregurgitation, stool frequency and consistency), caregiver quality of life, growth parameters (weight and length), health care utilization and antibiotic exposure, and overall safety\u002Ftolerability (adverse events and serious adverse events). Stool samples will be analyzed to explore changes in the gut microbiome.",[104,105,106,107,108],"Infantile Colic","Gastroesophageal Reflux (GER)","Functional Constipation","Functional Diarrhea","Dysbiosis",[110,111,112,113,114,115,116,117],"BioAmicus Complete","probiotic","multistrain probiotic","infant","functional gastrointestinal symptoms","Infant Gastrointestinal Symptom Questionnaire","gut microbiome","stool microbiome",{"date":119,"type":42},"2026-01-29",{"date":121,"type":42},"2025-09-05",{"date":123,"type":21},"2026-05-30",{"name":48,"class":49},{"id":126,"slug":127,"hasResults":11,"nctId":128,"briefTitle":129,"officialTitle":130,"acronym":131,"eligibilityCriteria":132,"healthyVolunteers":15,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":133,"targetDuration":4,"studyType":22,"phases":135,"briefSummary":137,"conditions":138,"keywords":142,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":153,"lastUpdatePostDateStruct":154,"startDateStruct":156,"completionDateStruct":158,"leadSponsor":160,"locationsCount":4},"100621361","phase-4-hla-b5801-guided-therapy-for-gout-effectiveness-safety-and-cost-effectiveness-100621361","NCT07369622","HLA-B*58:01-Guided Therapy for Gout: Effectiveness, Safety, and Cost-Effectiveness","A Prospective Interventional Study Comparing Genotype-Guided Therapy Versus Usual Care to Prevent Severe Cutaneous Adverse Reactions Associated With Allopurinol and Carbamazepine in Vietnam","HLA-SCREEN","Inclusion Criteria:\n\n* Age ≥ 18 years.\n\nDiagnosis of gout according to the 2020 ACR\u002FEULAR classification criteria.\n\nIndicated for initiation of urate-lowering therapy (ULT) and allopurinol-naïve (no prior allopurinol exposure).\n\nAble and willing to comply with scheduled follow-up visits (baseline, Months 1, 3, 6, and 12).\n\nProvides written informed consent for participation.\n\nFor the genotyping arms: provides consent for blood sampling and HLA-B\\*58:01 genotyping.\n\nExclusion Criteria:\n\n* Prior use of allopurinol or history of hypersensitivity reaction to allopurinol.\n\nKnown hypersensitivity to febuxostat (for participants who would receive febuxostat).\n\nCurrent or recent severe skin reaction (suspected\u002Fconfirmed SCAR) from any cause.\n\nEnd-stage kidney disease requiring dialysis or kidney transplantation.\n\nSevere hepatic impairment or active severe liver disease (e.g., AST\u002FALT \\>3× ULN at baseline).\n\nSevere uncontrolled medical conditions that, in the investigator's judgment, could interfere with treatment or follow-up (e.g., decompensated heart failure, active malignancy requiring intensive treatment).\n\nUse of systemic immunosuppressive therapy (e.g., high-dose corticosteroids, biologics, chemotherapy) at enrollment.\n\nPregnancy or breastfeeding.\n\nParticipation in another interventional clinical study that could affect the outcomes of this study.\n\nInability to provide informed consent or inability to adhere to study procedures.",{"count":134,"type":21},228,[136],"PHASE4","Severe cutaneous adverse reactions (SCARs), such as Stevens-Johnson syndrome\u002Ftoxic epidermal necrolysis (SJS\u002FTEN) and drug reaction with eosinophilia and systemic symptoms (DRESS), are rare but life-threatening complications that can occur after starting allopurinol for gout. The HLA-B58:01 allele is a strong genetic risk factor for allopurinol-associated SCARs in Asian populations. This study evaluates the feasibility and clinical value of HLA-B58:01 screening before first-time allopurinol use in Vietnamese adults with gout.\n\nAdults (≥18 years) diagnosed with gout (ACR\u002FEULAR 2020 criteria) and initiating urate-lowering therapy will be enrolled at Hai Phong International General Hospital (January 2025-June 2027). Participants who undergo HLA-B58:01 genotyping (PCR-based assay) will be treated according to test results: HLA-B58:01 negative participants receive allopurinol; HLA-B58:01 positive participants receive febuxostat. A comparison group consists of patients treated with febuxostat without HLA testing. Participants will be followed for 12 months with assessments at baseline, 1, 3, 6, and 12 months to monitor serum uric acid, gout flares, and safety outcomes (SCARs and other adverse events, including liver and kidney function). The study also includes an economic evaluation to estimate the cost-effectiveness of HLA-B58:01 screening for preventing SCARs and optimizing gout treatment.",[139,140,141],"Gout Initiating Urate-loweringUrate-lowering Therapy","Gout Arthritis","Gout and Hyperuricemia",[143,144,145,146,147,148,149,150,151,152],"HLA-B*58:01","HLA genotyping","Pharmacogenomics","Allopurinol","febuxostat","Pharmacogenetic screening","Severe cutaneous adverse reactions (SCARs)","Stevens-Johnson syndrome (SJS)","Toxic epidermal necrolysis (TEN)","Cost-effectiveness analysis","2026-01-18",{"date":155,"type":42},"2026-01-27",{"date":157,"type":21},"2026-01-20",{"date":159,"type":21},"2028-12-30",{"name":48,"class":49},{"id":162,"slug":163,"hasResults":11,"nctId":164,"briefTitle":165,"officialTitle":166,"acronym":167,"eligibilityCriteria":168,"healthyVolunteers":15,"sex":169,"minAge":170,"maxAge":171,"enrollmentInfo":172,"targetDuration":4,"studyType":22,"phases":174,"briefSummary":176,"conditions":177,"keywords":181,"overallStatus":81,"whyStopped":4,"lastUpdateSubmitDate":186,"lastUpdatePostDateStruct":187,"startDateStruct":189,"completionDateStruct":190,"leadSponsor":192,"locationsCount":193},"100597570","phase-1-food-effect-on-pk-of-dw-1021-pelubiprofen-45-mg--tramadol-459-mg-in-healthy-adults-100597570","NCT07060209","Food Effect on PK of DW-1021 (Pelubiprofen 45 mg \u002F Tramadol 45.9 mg) in Healthy Adults","A Randomized, Open-label, Single Oral Dose Clinical Trial to Evaluate the Food Effect on the Pharmacokinetics of Pelubiprofen-Tramadol (DW-1021) Controlled Release Film Coated Tablet (Pelubiprofen 45mg \u002F Tramadol 45.9mg) After Oral Administration in 14 Healthy Adult Vietnamese Male Subjects Under Fed and Fasting Conditions","DW-1021F","Inclusion Criteria:\n\n1. Healthy male subjects aged 20 to 40 years at screening visit\n2. Body Mass Index (BMI) between 18.5 and 24.9 kg\u002Fm²\n3. Body weight greater than 50 kg\n4. Systolic blood pressure between 100 mmHg and 129 mmHg; diastolic blood pressure less than 84 mmHg\n5. Regular heart rate ranging from 60 to 90 beats per minute\n6. No clinically significant medical history or evidence of congenital or chronic diseases, including but not limited to: hypertension, orthostatic hypotension, hypoglycemia when fasting, swallowing difficulties, diabetes, cardiovascular diseases, pulmonary diseases, gastrointestinal diseases, liver insufficiency, renal insufficiency, endocrine disorders, neurological or psychiatric disorders, immunological, hematological, or hereditary diseases, tuberculosis, or infectious diseases\n7. Suitable laboratory test results (hematology, urinalysis, blood chemistry, HCV\u002FAIDS, HBsAg, anti-HCV) and electrocardiogram (ECG) at screening: no pathological findings; clinical laboratory parameters within the normal range or, if outside the normal range, not clinically significant as judged by the investigator\n8. Willing and able to provide written informed consent after being fully informed about the study objectives and possible adverse effects\n9. Agree to use effective contraception from initial administration until 7 days after the last dose of test or reference drugs\n\nExclusion Criteria:\n\n1. Use of drugs that induce or inhibit drug-metabolizing enzymes (e.g., barbiturates) within 30 days prior to administration, or use of any medication that might affect the study within 10 days prior to administration\n2. Participation in any other clinical trial within 3 months prior to screening\n3. Blood donation within 8 weeks prior to drug administration\n4. History of gastrointestinal surgery that may affect drug absorption\n5. History of drug abuse, or use of alcohol, drugs, or tobacco products within 1 year before participation\n6. Known hypersensitivity or allergy to the test or reference drug or their components\n7. Known genetic disorders such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption, which are characterized by symptoms like diarrhea and bloating after consuming dairy products\n8. Suffering from dysphagia","MALE","18 Years","45 Years",{"count":173,"type":21},14,[175],"PHASE1","This is a Phase 1, open-label, single-dose crossover study designed to evaluate the effect of food on the pharmacokinetics of DW-1021, a fixed-dose combination tablet containing pelubiprofen 45 mg and tramadol 45.9 mg. Fourteen healthy adult Vietnamese males will each receive DW-1021 once under fasting conditions and once under fed conditions, with a 14-day washout period in between. Blood samples will be collected to assess how food intake affects the absorption and exposure levels of both active ingredients. Safety, including adverse events, laboratory results, vital signs, and ECGs, will be closely monitored throughout the study.",[178,179,180],"Healthy Volunteers","Pharmacokinetics","Food Effect in Healthy Volunteers",[182,183,184,185],"Pelubiprofen","DW-1021","Tramadol","Food effect","2025-08-22",{"date":188,"type":42},"2025-08-28",{"date":86,"type":21},{"date":191,"type":21},"2025-11-25",{"name":48,"class":49},2,{"id":195,"slug":196,"hasResults":11,"nctId":197,"briefTitle":198,"officialTitle":199,"acronym":183,"eligibilityCriteria":168,"healthyVolunteers":15,"sex":169,"minAge":170,"maxAge":171,"enrollmentInfo":200,"targetDuration":4,"studyType":22,"phases":201,"briefSummary":202,"conditions":203,"keywords":205,"overallStatus":81,"whyStopped":4,"lastUpdateSubmitDate":186,"lastUpdatePostDateStruct":208,"startDateStruct":209,"completionDateStruct":210,"leadSponsor":212,"locationsCount":193},"100595446","phase-1-comparison-of-dw-1021-and-separate-doses-of-pelubi-cr-and-zytram-cr-under-fasting-conditions-100595446","NCT07032558","Comparison of DW-1021 and Separate Doses of Pelubi CR and Zytram CR Under Fasting Conditions","A Randomized, Open-label, Single Oral Dose, Two-period, Cross-over Trial to Evaluate the Pharmacokinetics of Pelubiprofen-Tramadol (DW-1021) Controlled Release Film Coated Tablets (Pelubiprofen 45mg-Tramadol 45.9mg Salt) (Test Drug) in Comparison With the Co-administration of Each of Pelubi CR 45mg Controlled Release Film Coated Tablets (Pelubiprofen 45mg) and Zytram CR 75mg Controlled Release Film Coated Tablets (Tramadol HCl 75mg) in Healthy Adult Vietnamese Male Subjects Under Fasting Condition",{"count":173,"type":21},[175],"This is a Phase 1, randomized, open-label, single-dose, two-period, cross-over study to evaluate the pharmacokinetics (PK) of DW-1021, a fixed-dose combination tablet containing Pelubiprofen 45 mg and Tramadol 45.9 mg (as a salt), in healthy adult Vietnamese male volunteers. The study compares DW-1021 with the co-administration of two reference drugs: Pelubi CR 45 mg (Pelubiprofen) and Zytram CR 75 mg (Tramadol HCl), under fasting conditions.\n\nA total of 14 eligible participants will be randomly assigned to receive either the test drug followed by the reference drugs, or vice versa, with a 14-day washout period between the two dosing periods. Blood samples will be collected over a 48-hour period after each administration to evaluate drug concentrations. The main purpose is to assess and compare the rate and extent of absorption (Cmax, AUC) of the test and reference products.\n\nThe study is sponsored by Haiphong University of Medicine and Pharmacy in collaboration with Daewon Pharmaceutical Co., Ltd. It is conducted under ethical approval by the National Ethics Committee in Biomedical Research of Vietnam.",[204],"Healthy Volunteer",[182,184,183,179,206,207],"Fixed-Dose Combination","Bioavailability",{"date":188,"type":42},{"date":86,"type":21},{"date":211,"type":21},"2025-10-25",{"name":48,"class":49},""]