Pilot Bioequivalence Study of Chiglitazar/Metformin Extended-Release Tablets

Exclusion Criteria

• •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/metabolic disorders;
• •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;
• •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;
• •Surgery within 3 months prior to screening or planned surgery during the study period;
• •Received any vaccination within 1 month prior to screening or plan to receive any vaccination during the study period;
• •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;
• •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;
• •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;
• •History of drug or substance abuse, or a positive alcohol or urine drug screening test;
• •Intolerance to venipuncture, or a history of fainting in response to needles or blood;
• •Fasting blood glucose \> 6.1 mmol/L or \< 3.9 mmol/L at screening, and/or a history of hypoglycemia/syncope;
• •Participation in any interventional clinical trial within 3 months prior to screening;
• •Blood donation or significant blood loss (\> 200 mL) within 3 months prior to screening;
• •Pregnant or lactating women;
• •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;
• •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;
• •Excessive daily consumption of tea, coffee, and/or caffeinated beverages within 3 months prior to screening, or consumption of such beverages within 48 hours before the first dose;
• •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;
• •Glomerular Filtration Rate (GFR) \< 90 mL/min/1.73 m²;
• •Systolic blood pressure \< 90 mmHg or ≥ 140 mmHg, or diastolic blood pressure \< 60 mmHg or ≥ 90 mmHg at screening;
• •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;
• •Inability to comply with the standardized diet (e.g., intolerance to the high-fat meal, lactose intolerance) or has difficulty swallowing;
• •Plans to or is required to engage in strenuous physical activity or exercise during the study period;
• •Any other condition that, in the opinion of the investigator, makes the participant unsuitable for inclusion in the study.