[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100624621":3},{"organization":4,"armGroups":7,"interventions":27,"overallOfficials":33,"centralContacts":33,"locations":33,"responsibleParty":46,"collaborators":33,"id":48,"slug":49,"hasResults":50,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":33,"eligibilityCriteria":54,"healthyVolunteers":55,"sex":56,"minAge":57,"maxAge":58,"enrollmentInfo":59,"targetDuration":33,"studyType":62,"phases":63,"briefSummary":65,"conditions":66,"keywords":33,"overallStatus":68,"whyStopped":33,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":33},{"fullName":5,"class":6},"Chipscreen Biosciences, Ltd.","INDUSTRY",[8,15,19,24],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment Sequence T-R (dose 1)","EXPERIMENTAL","Participants will receive treatment T (Chiglitazar\u002FMetformin extended-release fixed dose combination tablets) on Day 1 followed by treatment R (Chiglitazar tablets and Metformin extended-release tablets) on Day 8.",[13,14],"Drug: treatment T (dose 1)","Drug: treatment R (dose 1)",{"label":16,"type":10,"description":17,"interventionNames":18},"Treatment Sequence R-T (dose 1)","Participants will receive treatment R (Chiglitazar tablets and Metformin extended-release tablets) on Day 1 followed by treatment T (Chiglitazar\u002FMetformin extended-release fixed dose combination tablets) on Day 8.",[13,14],{"label":20,"type":10,"description":11,"interventionNames":21},"Treatment Sequence T-R (dose 2)",[22,23],"Drug: treatment T (dose 2)","Drug: treatment R (dose 2)",{"label":25,"type":10,"description":17,"interventionNames":26},"Treatment Sequence R-T (dose 2)",[22,23],[28,34,38,42],{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"DRUG","treatment T (dose 1)","Chiglitazar\u002FMetformin extended-release fixed dose combination tablets (dose 1)",[16,9],null,{"type":29,"name":35,"description":36,"armGroupLabels":37,"otherNames":33},"treatment T (dose 2)","Chiglitazar\u002FMetformin extended-release fixed dose combination tablets (dose 2)",[25,20],{"type":29,"name":39,"description":40,"armGroupLabels":41,"otherNames":33},"treatment R (dose 1)","Chiglitazar tablets and Metformin extended release tablets (dose 1)",[16,9],{"type":29,"name":43,"description":44,"armGroupLabels":45,"otherNames":33},"treatment R (dose 2)","Chiglitazar tablets and Metformin extended release tablets (dose 2)",[25,20],{"type":47,"investigatorFullName":33,"investigatorTitle":33,"investigatorAffiliation":33,"oldNameTitle":33,"oldOrganization":33},"SPONSOR","100624621","pilot-bioequivalence-study-of-chiglitazarmetformin-extended-release-tablets-100624621",false,"NCT07412015","Pilot Bioequivalence Study of Chiglitazar\u002FMetformin Extended-Release Tablets","Pilot 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 60 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":60,"type":61},24,"ESTIMATED","INTERVENTIONAL",[64],"NA","This is a pilot bioequivalence study. It is a randomized, open-label, single-dose, crossover study. The primary objective of this study is to preliminarily evaluate the pharmacokinetic parameters and their variability of the test formulation versus the reference formulation following a single oral dose under fed conditions.",[67],"T2DM (Type 2 Diabetes Mellitus)","NOT_YET_RECRUITING","2026-02-09",{"date":71,"type":72},"2026-02-17","ACTUAL",{"date":74,"type":61},"2026-05-27",{"date":76,"type":61},"2026-06-29",{"name":5,"class":6}]