[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"bioequivalence\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:bioequivalence":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,41,67],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100600390","phase-1-bioequivalence-study-of-paclitaxel-protein-bound-particles-for-injectable-suspension-albumin-bound-in-breast-cancer-patients-100600390",false,"NCT07096869","Bioequivalence Study of Paclitaxel Protein-bound Particles for Injectable Suspension (Albumin-bound) in Breast Cancer Patients","A Randomized, Open-Label, Two-Period, Crossover Bioequivalence Study of Paclitaxel Protein-bound Particles for Injectable Suspension (Albumin-bound) and Abraxane® in Breast Cancer Patients","Inclusion Criteria:\n\n* 1\\) Subjects fully understand the purpose, nature, method and possible adverse reactions of the study, volunteer as subjects, and sign informed consent prior to the commencement of any study procedure;\n* 2\\) Male and female, ages 18-75 years both inclusive;\n* 3\\) Subjects with breast cancer confirmed by histopathology and\u002For cytology who meet one of the following conditions: ①Metastatic breast cancer, after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated; ②This treatment criteria (NCCN guidelines and CSCO guidelines - Breast cancer) is used to determine whether the subjects are suitable for paclitaxel for injection (albumin-bound) monotherapy. ③Subjects received standard treatment without conditions and were judged to benefit from injectable paclitaxel (albumin-binding) monotherapy;\n* 4\\) ECOG Score ≤ 2 points;\n* 5\\) The expecting life span ≥ 3months;\n* 6\\) The results of blood, liver and kidney function tests are within the following ranges: Absolute neutrophil counts (ANC) ≥ 1.5×10\\^9\u002FL Platelets (PLT) ≥ 100×10\\^9\u002FL Hemoglobin (Hb) ≥ 90 g\u002FL Total bilirubin (TBIL) ≤ 1.5×ULN Alanine transaminase (ALT), Aspartate aminotransferase (AST)≤×ULN (for patients with liver metastasis, ≤ 5×ULN) Creatinine clearance (CrCL)≥ 60 mL\u002Fmin\n* 7\\) The subject has no fertility plan (including sperm donation and egg donation) for at least 6 months from the signing of informed consent to the last dose and voluntarily takes non-drug effective contraceptive measures;\n* 8\\) Subjects can communicate well with the investigators, understand and comply with the requirements of the study.\n\nExclusion Criteria:\n\n* 1\\) A severe allergy or hypersensitivity to paclitaxel or human albumin;\n* 2\\) In addition to cancer, have any other serious liver, kidney\u002Fgenitourinary, gastrointestinal (e.g., abdominal inflammation), cardiovascular (e.g., congestive heart failure, ventricular arrhythmia, myocardial infarction, unstable angina), cerebrovascular, pulmonary (e.g., interstitial lung disease), endocrine, immune, musculoskeletal, neurological, psychiatric, skin, or blood (e.g., bleeding diathymia or clotting disorders) diseases Patients with a known or present history of the disease who are deemed unsuitable for enrollment by the investigators;\n* 3\\) Those who had undergone major surgery within 4 weeks prior to screening, or planned to undergo major surgery during the study period;\n* 4\\) Pregnant or lactating female subjects;\n* 5\\) Hepatitis B surface antigen positive and HBV DNA positive; HCV core antibody positive and HCV RNA positive; HIV antigen\u002Fantibody positive; treponema pallidum antibody positive and rapid plasma reaction hormone (RPR) positive;\n* 6\\) Those who used chemical small molecule anti-tumor drugs (including endocrine therapy), biological macromolecular anti-tumor drugs, biological therapy, radiotherapy or needed to combine other anti-tumor drugs for treatment during the study period within 4 weeks before the first dose;\n* 7\\) Electrocardiogram shows significant abnormality, and\u002For baseline QTcF interval is \\> 470 ms;\n* 8\\) Pre-screening sensory neuropathy\u002Fperipheral neuropathy are ≥ grade 2;\n* 9\\) Blood donation or significant blood loss (\\> 400 mL) within 90 days before - screening;\n* 10\\) Ingestion of an inhibitor or inducer of CYP2C8 or CYP3A4 within 28 days prior to dosing (acceptable drug use is stable in homeostasis, that is, the dosing regimen remains unchanged; However, the use of moderate-strong inhibitory agents\u002Fmoderate-strong inducers should be prohibited), or drugs (including Chinese herbs) that can affect the absorption, distribution, metabolism and excretion behavior of the study drugs or special diets (such as products containing caffeine or xanthine, grapefruit fruits and products containing grapefruit ingredients, etc.);\n* 11\\) Those who consumed more than 14 units of alcohol per week in the 3 months before screening (1 unit ≈ 360 mL for beer, or 45 mL for spirits, or 150 mL for wine) or who could not stop drinking during the study period or who are breath-positive for alcohol;\n* 12\\) Smoking \\> 5 cigarettes per day within 3 months prior to screening or smoking cannot be stopped during the study period;\n* 13\\) Any clinically significant abnormal results in the subjects' vital signs, physical examination, clinical laboratory examination (unless otherwise specified in the protocol), 12-lead electrocardiogram (ECG) and other examination results that the investigator deems unsuitable for enrollment;\n* 14\\) Within 6 months prior to screening, there is a history of drug abuse (except regular use of pain medications due to cancer pain) or positive drug abuse screening;\n* 15\\) Toxicity caused by using of anti-tumor drugs prior to enrolment do not return to ≤ grade 1 or baseline levels, except for alopecia;\n* 16\\) Subjects receiving granulocyte-stimulating growth factor treatment within 2 weeks before dosing;\n* 17\\) Subjects who have participated in any clinical trial within 1 month before screening (start from the time of the last dose);\n* 18\\) Any other circumstances determined by the investigator to be inappropriate are not suitable for participation in this study","ALL","18 Years","75 Years",{"count":20,"type":21},28,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","The main purpose of this study is to evaluate the bioequivalence of paclitaxel protein-bound particles for injectable suspension (albumin-bound) (100 mg, test product) and Abraxane® (100 mg, reference product) in breast cancer patients.",[27],"Bioequivalence","RECRUITING","2025-07-24",{"date":31,"type":32},"2025-07-31","ACTUAL",{"date":34,"type":32},"2025-06-26",{"date":36,"type":21},"2026-02-25",{"name":38,"class":39},"CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.","INDUSTRY",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":47,"sex":16,"minAge":17,"maxAge":48,"enrollmentInfo":49,"targetDuration":4,"studyType":22,"phases":51,"briefSummary":52,"conditions":53,"keywords":54,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":4},"100579950","phase-1-bioequivalence-study-of-fluvastatin-sodium-extended-release-tablets-in-healthy-participants-100579950","NCT06830954","Bioequivalence Study of Fluvastatin Sodium Extended Release Tablets in Healthy Participants","Inclusion Criteria:\n\n* Participants have fully understood the trial's objectives, procedures, and potential adverse effects, and voluntarily signed informed consent form prior to the trial.\n* Participants are able to communicate effectively with the investigator and comply with the protocol requirements to complete the trial.\n* Healthy male or female adults aged 18 to 65 years (inclusive).\n* Body weight ≥50 kg for male participants and ≥45 kg for female participants at screening, with a body mass index (BMI) between 19.0 and 26.0 kg\u002Fm2 (inclusive; BMI = body weight ÷ height2).\n* No abnormalities or only slight abnormalities not clinically significant of tests\u002Fexaminations as judged by the investigator. Alanine aminotransferase (ALT), aspartate aminotransferase (AST), and creatine kinase (CK) must not exceed the upper limit of the normal reference range.\n\nParticipants or their partners must not have any pregnancy plans during the study and for three months after the last administration of the investigational drug. They must voluntarily take effective contraceptive measures (the use of contraceptive medications is prohibited during the study) to avoid pregnancy for themselves or their partners, and participants must not donate sperm or eggs (ovum and oocytes) for reproductive or assisted reproductive purposes.\n\nExclusion Criteria:\n\n* Pregnant or lactating women, or women of child-bearing potential (WOCBP) with a positive pregnancy test at screening.\n* Participants who have a history of clinically significant acute allergy to drug or food within two weeks prior to screening, or have an allergic constitution (e.g., allergy to two or more drugs, food, or pollens), or have a history of allergic diseases (e.g., asthma, urticaria, eczematous dermatitis, etc.), or have possible or definite allergy, hypersensitivity or clinically significant reactions to investigational drugs or excipients judged by the investigator.\n* Participants with any disease (e.g., acute gastritis, peptic ulcer, anaphylactoid purpura, lupus erythematosus, etc.) or history (e.g., haemorrhage intracranial, hemorrhage intraocular, haemophilia, angiohaemophilia, etc.) that may change or aggravate haemorrhagic diathesis as judged by the investigator.\n* Participants with a positive result for any of the following tests: hepatitis B surface antigen test, hepatitis C antibody test, HIV antibody test, and treponema pallidum antibody test.\n* Drug abuse, alcohol abuse, or tobacco addiction:\n\nParticipants with a history of drug abuse, or a positive result for drug abuse test at screening; Participants with an average alcohol consumption of more than 14 units per week (1 unit ≈ 17.7 mL of ethanol, i.e., 1 unit ≈ 360 mL of beer with 5% alcohol content or 45 mL of spirit with 40% alcohol content or 150 mL of wine with 12% alcohol content) within 3 months prior to screening, or with a positive result for breath alcohol test at screening, or those who could not completely stop consuming alcohol-containing food or beverages during the study; Participants with an average tobacco consumption of more than 5 cigarettes per day within 3 months prior to screening, or those who could not completely stop consuming tobacco products during the study.\n\n•Subjects who used any of the following food, medications, or treatments prior to the first dose: Used any drugs that inhibit or induce liver drug metabolism (e.g., inducers such as barbiturates, carbamazepine, phenytoin, rifampicin; inhibitors such as SSRI antidepressants, cimetidine, diltiazem, macrolides, nitroimidazoles, sedative-hypnotics, verapamil, fluoroquinolones, antihistamines) within four weeks prior to the first dose.; Female participants who have used long-acting estrogen or progestin injections or implants within six months prior to screening; Used any prescription drugs, Chinese herbal medicines, or food supplements (including vitamins, health-care food, etc.) within 2 weeks prior to the first dose; Habitual consumption of grapefruit or grapefruit juice-containing products within 1 week prior to screening, or unwillingness to abstain from grapefruit-containing foods or beverages from 48 hours before dosing of the first period to 48 hours after dosing of the fourth period; Consumption of xanthine-rich foods or beverages (e.g., chocolate, cocoa beans, coffee) within 48 hours prior to the first dose, or unwillingness to abstain from xanthine-rich foods or beverages from 48 hours before the dosing of first period to 48 hours after dosing of the fourth period.\n\nConsumed tea, coffee, and\u002For foods or beverages containing caffeine within 48 hours prior to the first dose, or do not agree to refrain from consuming tea, coffee, and\u002For foods or beverages containing caffeine from 48 hours before dosing of the first period until 48 hours after dosing of the fourth period.\n\n* Participants who participated or are participating in any interventional clinical study (including investigational drug or vaccine, and other clinical studies of fluvastatin or other cohorts of this study) and received drugs within 3 months prior to screening.\n* Participants with dysphagia or special dietary requirements who cannot adhere to a standardized diet.\n* Participants who received live vaccines, attenuated vaccines, or vaccines containing any live viral components within 3 months prior to screening, or those who plan to receive any of these vaccines during the study.\n* Participants who experienced blood donation (including component blood donation) or blood loss ≥ 400 mL within 3 months prior to screening; or blood donation (including component blood donation) or blood loss ≥ 200 mL or blood transfusion within 1 month prior to screening; or those who plan to donate blood or blood components during the study or within 1 month after the end of study.\n* Participants who experienced major trauma or had a major surgery (e.g., surgery requiring general anesthesia) within 3 months prior to screening, or those who plan to undergo a surgery (except for surgery requiring local anesthesia) during the study or within 3 months after the end of study.\n* Participants who have difficulty veins or cannot bear multiple venipunctures, or those with a history of clinically significant fear of needles or hemophobia as judged by the investigator.\n* Participants with other diseases or medical history that are clinically significant or may prevent the subjects from completing this study as judged by the investigator (including various systems such as respiratory, cardiovascular, digestive, genitourinary, hematologic, endocrine, neurological, and psychiatric systems, and malignant tumors), or other diseases or medical history that may significantly alter drug absorption, metabolism, or elimination (e.g., history of gastrointestinal surgery, renal surgery, or cholecystectomy, which may affect the in vivo disposition of the drug), or infectious diseases.\n* Participants with a history of musculoskeletal and connective tissue disorders (e.g., myalgia, myopathy) or a history of hereditary muscle diseases or rhabdomyolysis.\n\nParticipants who are not suitable for participating in this study for any other reasons as judged by the investigator.",true,"65 Years",{"count":50,"type":21},110,[24],"The purpose of this study is to evaluate the bioequivalence of the test preparation (Fluvastatin sodium extended release tablet, 80 mg) manufactured by Shenzhen Salubris Pharmaceuticals Co., Ltd. and the reference preparation (80 mg) manufactured by Beijing Novartis Pharma Co., Ltd. in healthy participants under fasting and fed conditions.",[27],[55,56,27],"Fluvastatin","Pharmacokinetics","NOT_YET_RECRUITING","2025-02-13",{"date":60,"type":32},"2025-02-17",{"date":62,"type":21},"2025-02",{"date":64,"type":21},"2025-12",{"name":66,"class":39},"Shenzhen Salubris Pharmaceuticals Co., Ltd.",{"id":68,"slug":69,"hasResults":11,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":4,"eligibilityCriteria":73,"healthyVolunteers":47,"sex":16,"minAge":17,"maxAge":74,"enrollmentInfo":75,"targetDuration":4,"studyType":22,"phases":77,"briefSummary":79,"conditions":80,"keywords":84,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":40},"100574380","coffee-bioequivalence-trial-100574380","NCT06758531","Coffee Bioequivalence Trial","Coffee Bioequivalence Trial: Comparing the Pharmacokinetics of Bioactive Components and Physiological Effects of Consuming Encapsulated Instant Coffee Versus Traditional Instant Coffee Brewed in Water","Inclusion Criteria:\n\n* Healthy males and pre-menopausal females (must have regular menstrual cycles)\n* Aged between 18 to 45 years\n* Body mass index (BMI) between 18.5-30 kg\u002Fm2\n\nExclusion Criteria:\n\n* Sensitivity to coffee and caffeine\n* Food allergies relating to the test meals provided (such as gluten or lactose intolerance)\n* Current smoking and vaping use.\n* Medical history of chronic diseases (cancer, high blood pressure (hypertension), type 2 diabetes, heart attack and\u002For any other heart disease related diseases, gastrointestinal disorders, hyperlipidaemia, kidney or liver disease).\n* Diagnosed with anaemia\n* Prescribed any medication relating to the study outcome measures (such as blood pressure lowering, anti-inflammatories or blood thinners).\n* Drinking more than the recommended intake for alcohol (\\> 14 units\u002Fweek)\n* Taking any supplements (vitamins, minerals, probiotics).\n* Any other unusual medical history or diet and lifestyle habits or practices that would preclude volunteers from participating in a dietary intervention and metabolic study (e.g. pacemaker)\n* Planning on a weight-reducing regimen (lost \\>3 kg in the last 6 months)\n* Parallel participation in another intervention study\n* Pregnancy, planning a pregnancy in the next 6 months or breastfeeding\n* NHS blood donation in the last 3 months","45 Years",{"count":76,"type":21},16,[78],"NA","The goal of this clinical trial is to test if coffee consumed as a tablet is biologically equivalent to that consumed traditionally as a drink. It will also learn about the impact of the short-term intake of coffee on markers of cardiovascular and liver health. The main questions it aims to answer are:\n\n* Do coffee bioactive compounds produce the same levels in blood and urine regardless of how the coffee is consumed (tablet or drink)?\n* How does coffee as a tablet or drink impact cardiovascular risk and liver health versus a non-coffee control?\n\nParticipants will:\n\n* Visit the clinical unit for three phases; each phase is 1x 480 minute (eight hour) acute postprandial visit and 1 x one hour visit the following day. During each phase they will be randomly assigned to take a different intervention (coffee drink, coffee tablet, coffee-free control)\n* Be cannulated during the 480 minute (8 hour) acute visits and have regular blood draws as well as basic clinical assessments\n* Return on day two for a fasting blood sample and basic clinical assessment\n* Collect their urine for 24 h\n* Be asked to record their intake of foods and drinks for 3 days to assess their usual diet (dietary assessment).",[81,27,82,83],"Liver Functions","Cardiovascular Risk","Cardiometabolic Risk Markers",[85,27,86,87,88,89,90,91],"Coffee","Caffeine","Liver function","Polyphenols","Blood pressure","Cardiovascular disease","Chlorogenic acids","2025-01-02",{"date":94,"type":32},"2025-01-03",{"date":96,"type":21},"2025-01",{"date":98,"type":21},"2025-12-30",{"name":100,"class":101},"University of Reading","OTHER"]