[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100632232":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":11,"centralContacts":11,"locations":11,"responsibleParty":36,"collaborators":11,"id":38,"slug":39,"hasResults":40,"nctId":41,"briefTitle":42,"officialTitle":43,"acronym":11,"eligibilityCriteria":44,"healthyVolunteers":45,"sex":46,"minAge":47,"maxAge":48,"enrollmentInfo":49,"targetDuration":11,"studyType":52,"phases":53,"briefSummary":55,"conditions":56,"keywords":11,"overallStatus":58,"whyStopped":11,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":11},{"fullName":5,"class":6},"Chipscreen Biosciences, Ltd.","INDUSTRY",[8,15,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Sequence 1 of FE study","EXPERIMENTAL",null,[13,14],"Drug: Chiglitazar\u002FMetformin extended-release tablets under fasting conditions","Drug: Chiglitazar\u002FMetformin extended-release tablets after a high-fat meal",{"label":16,"type":10,"description":11,"interventionNames":17},"Sequence 2 of FE study",[13,14],{"label":19,"type":10,"description":11,"interventionNames":20},"multiple-dose group",[21],"Drug: multiple-dose of Chiglitazar\u002FMetformin extended-release tablets",[23,28,32],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":11},"DRUG","Chiglitazar\u002FMetformin extended-release tablets under fasting conditions","a single dose of Chiglitazar\u002FMetformin extended-release tablets under fasting conditions",[9,16],{"type":24,"name":29,"description":30,"armGroupLabels":31,"otherNames":11},"Chiglitazar\u002FMetformin extended-release tablets after a high-fat meal","a single dose of Chiglitazar\u002FMetformin extended-release tablets after a high-fat meal",[9,16],{"type":24,"name":33,"description":34,"armGroupLabels":35,"otherNames":11},"multiple-dose of Chiglitazar\u002FMetformin extended-release tablets","a single dose on Day 1, once-daily consecutive doses from Day 4 to Day 10",[19],{"type":37,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100632232","phase-1-food-effect-and-multiple-dose-study-of-chiglitazarmetformin-extended-release-tablets-100632232",false,"NCT07511010","Food Effect and Multiple-Dose Study of Chiglitazar\u002FMetformin Extended-Release Tablets","A Phase I Clinical Study to Assess the Food Effect and Multiple Dose Pharmacokinetic of Chiglitazar\u002FMetformin Extended-Release Fixed Dose Combination Tablets","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* 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":50,"type":51},28,"ESTIMATED","INTERVENTIONAL",[54],"PHASE1","This trial includes two parts: a food effect (FE) study and a multiple-dose pharmacokinetic (PK) study.\n\nThe FE study is a randomized, open-label, two-period, two-sequence crossover study designed to evaluate the effect of a high-fat meal on the PK of a single oral dose of Chiglitazar\u002FMetformin extended-release tablets in healthy adult Chinese participants.\n\nThe multiple-dose PK study is an open-label study designed to evaluate the PK characteristics of Chiglitazar\u002FMetformin extended-release tablets in healthy adult Chinese participants following multiple oral doses.",[57],"T2DM (Type 2 Diabetes Mellitus)","NOT_YET_RECRUITING","2026-04-01",{"date":61,"type":62},"2026-04-06","ACTUAL",{"date":64,"type":51},"2026-10-08",{"date":66,"type":51},"2026-10-26",{"name":5,"class":6}]