[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100632867":3},{"organization":4,"armGroups":7,"interventions":31,"overallOfficials":37,"centralContacts":37,"locations":37,"responsibleParty":58,"collaborators":37,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":37,"eligibilityCriteria":66,"healthyVolunteers":67,"sex":68,"minAge":69,"maxAge":70,"enrollmentInfo":71,"targetDuration":37,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":37,"overallStatus":80,"whyStopped":37,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":37},{"fullName":5,"class":6},"Chipscreen Biosciences, Ltd.","INDUSTRY",[8,16,20,27],{"label":9,"type":10,"description":11,"interventionNames":12},"Sequence T-R (dose 1)","EXPERIMENTAL","Participants will receive Chiglitazar\u002FMetformin extended-release fixed dose combination tablets at dose level 1 in Period 1 on Day 1, followed by Chiglitazar tablets and Metformin extended-release tablets at dose level 1 in Period 2 on Day 1.",[13,14,15],"Drug: Chiglitazar\u002FMetformin extended-release fixed-dose combination tablet, dose 1","Drug: Chiglitazar tablet, dose 1","Drug: Metformin extended-release tablet, dose 1",{"label":17,"type":10,"description":18,"interventionNames":19},"Sequence R-T (dose 1)","Participants receive chiglitazar tablet and metformin extended-release tablet at dose level 1 in Period 1 on Day 1, followed by chiglitazar\u002Fmetformin extended-release fixed-dose combination tablet at dose level 1 in Period 2 on Day 1.",[13,14,15],{"label":21,"type":10,"description":22,"interventionNames":23},"Sequence T-R (dose 2)","Participants receive chiglitazar\u002Fmetformin extended-release fixed-dose combination tablet at dose level 2 in Period 1 on Day 1, followed by chiglitazar tablet and metformin extended-release tablet at dose level 2 in Period 2 on Day 1.",[24,25,26],"Drug: Chiglitazar\u002FMetformin extended-release fixed-dose combination tablet, dose 2","Drug: Chiglitazar tablet, dose 2","Drug: Metformin extended-release tablet, dose 2",{"label":28,"type":10,"description":29,"interventionNames":30},"Sequence R-T (dose 2)","Participants receive chiglitazar tablet and metformin extended-release tablet at dose level 2 in Period 1 on Day 1, followed by chiglitazar\u002Fmetformin extended-release fixed-dose combination tablet at dose level 2 in Period 2 on Day 1.",[24,25,26],[32,38,42,46,50,54],{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":37},"DRUG","Chiglitazar\u002FMetformin extended-release fixed-dose combination tablet, dose 1","Fixed-dose combination tablet containing chiglitazar and metformin extended-release, administered at dose level 1.",[17,9],null,{"type":33,"name":39,"description":40,"armGroupLabels":41,"otherNames":37},"Chiglitazar tablet, dose 1","Chiglitazar tablet administered as one of the reference treatment at dose level 1.",[17,9],{"type":33,"name":43,"description":44,"armGroupLabels":45,"otherNames":37},"Metformin extended-release tablet, dose 1","Metformin extended-release tablet administered as one of the reference treatment at dose level 1.",[17,9],{"type":33,"name":47,"description":48,"armGroupLabels":49,"otherNames":37},"Chiglitazar\u002FMetformin extended-release fixed-dose combination tablet, dose 2","Fixed-dose combination tablet containing chiglitazar and metformin extended-release, administered at dose level 2.",[28,21],{"type":33,"name":51,"description":52,"armGroupLabels":53,"otherNames":37},"Chiglitazar tablet, dose 2","Chiglitazar tablet administered as one of the reference treatment at dose level 2.",[28,21],{"type":33,"name":55,"description":56,"armGroupLabels":57,"otherNames":37},"Metformin extended-release tablet, dose 2","Metformin extended-release tablet administered as one of the reference treatment at dose level 2.",[28,21],{"type":59,"investigatorFullName":37,"investigatorTitle":37,"investigatorAffiliation":37,"oldNameTitle":37,"oldOrganization":37},"SPONSOR","100632867","bioequivalence-study-of-chiglitazarmetformin-extended-release-tablets-100632867",false,"NCT07519265","Bioequivalence Study of Chiglitazar\u002FMetformin Extended-Release Tablets","Bioequivalence Study of Chiglitazar\u002FMetformin Extended-Release Fixed Dose Combination Tablets in Healthy Subjects: A Randomized, Open-Label, Two-Period, Single-dose, Crossover Trial Under Fed Conditions","Inclusion Criteria:\n\n* Healthy male or female participants；\n* Age from 18 to 45 years, inclusive；\n* Body Mass Index (BMI) between 19.0 and 26.0 kg\u002Fm² (inclusive). Male participants must weigh at least 50.0 kg, and female participants must weigh at least 45.0 kg；\n* From the time of signing the informed consent form until 3 months after the last dose, participants must have no plans for pregnancy or sperm donation and must be willing to use effective contraceptive measures；\n* Voluntarily agrees to participate in the study and signs the informed consent form.\n\nExclusion Criteria:\n\n* Any clinically significant abnormalities in laboratory tests or a history of clinically significant diseases, including but not limited to cardiovascular, cerebrovascular, hepatic, renal, respiratory, gastrointestinal, neurological, hematological, immune, oncological, psychiatric, or endocrine\u002Fmetabolic disorders;\n* Known history of severe allergies (e.g., allergy to more than 3 allergens, allergies affecting the lower respiratory tract such as allergic asthma, allergies requiring glucocorticoid treatment) or a known history of allergy to any component of the investigational products;\n* Previous surgery that could affect drug absorption, distribution, metabolism, or excretion (e.g., subtotal gastrectomy), or a history of gastrointestinal, hepatic, or renal disease within the last 6 months that could affect drug absorption or metabolism;\n* Surgery within 3 months prior to screening or planned surgery during the study period;\n* Received any vaccination within 1 month prior to screening or plan to receive any vaccination during the study period;\n* History of infectious disease treated with significant use of antibiotics within 3 months before the first dose, or any infectious disease within 7 days before the first dose;\n* Presence of gastrointestinal symptoms (e.g., diarrhea, constipation, nausea, vomiting) within 7 days before the first dose, which the investigator deems unsuitable for study participation;\n* Use of any prescription drugs, over-the-counter drugs, or Chinese herbal medicines within 1 month before the first dose; or use of vitamin products within 2 weeks before enrollment;\n* History of drug or substance abuse, or a positive alcohol or urine drug screening test;\n* Intolerance to venipuncture, or a history of fainting in response to needles or blood;\n* Fasting blood glucose \\> 6.1 mmol\u002FL or \\\u003C 3.9 mmol\u002FL at screening, and\u002For a history of hypoglycemia\u002Fsyncope;\n* Participation in any interventional clinical trial within 3 months prior to screening;\n* Blood donation or significant blood loss (\\> 200 mL) within 3 months prior to screening;\n* Pregnant or lactating women;\n* Weekly alcohol consumption of more than 14 units within 3 months prior to screening, consumption of alcohol within 48 hours before the first dose, or inability to abstain from alcohol during the study;\n* Smokes more than 5 cigarettes per day within 3 months prior to screening, has smoked within 48 hours before the first dose, or is unable to abstain from smoking during the study;\n* Excessive daily consumption of tea, coffee, and\u002For caffeinated beverages within 3 months prior to screening, or consumption of such beverages within 48 hours before the first dose;\n* Consumption of grapefruit or grapefruit-related citrus fruits (e.g., Seville oranges, pomelos), star fruit, papaya, pomegranate, or their products within 14 days before the first dose;\n* Glomerular Filtration Rate (GFR) \\\u003C 90 mL\u002Fmin\u002F1.73 m²;\n* Systolic blood pressure \\\u003C 90 mmHg or ≥ 140 mmHg, or diastolic blood pressure \\\u003C 50 mmHg or ≥ 90 mmHg at screening;\n* A positive test result at screening for any of the following: Human Immunodeficiency Virus antibody, Treponema pallidum antibody, Hepatitis B surface antigen, or Hepatitis C virus antibody;\n* Inability to comply with the standardized diet (e.g., intolerance to the high-fat meal, lactose intolerance) or has difficulty swallowing;\n* Plans to or is required to engage in strenuous physical activity or exercise during the study period;\n* Any other condition that, in the opinion of the investigator, makes the participant unsuitable for inclusion in the study.",true,"ALL","18 Years","45 Years",{"count":72,"type":73},64,"ESTIMATED","INTERVENTIONAL",[76],"NA","This is a single-center, randomized, open-label, two-period, two-sequence crossover bioequivalence study under fed conditions. The primary objective is to evaluate the bioequivalence of a single oral dose of the test formulation compared with the reference formulation in the fed state.",[79],"T2DM (Type 2 Diabetes Mellitus)","NOT_YET_RECRUITING","2026-04-07",{"date":83,"type":84},"2026-04-09","ACTUAL",{"date":86,"type":73},"2026-07-09",{"date":88,"type":73},"2026-08-10",{"name":5,"class":6}]