This trial includes two parts: a food effect (FE) study and a multiple-dose pharmacokinetic (PK) study.
The 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/Metformin extended-release tablets in healthy adult Chinese participants.
The multiple-dose PK study is an open-label study designed to evaluate the PK characteristics of Chiglitazar/Metformin extended-release tablets in healthy adult Chinese participants following multiple oral doses.
Healthy male or female participants；
Age from 18 to 45 years, inclusive；
Body Mass Index (BMI) between 19.0 and 26.0 kg/m² (inclusive). Male participants must weigh at least 50.0 kg, and female participants must weigh at least 45.0 kg；
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；
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;
Crossover
Chiglitazar/Metformin extended-release tablets under fasting conditions
Druga single dose of Chiglitazar/Metformin extended-release tablets under fasting conditions
Chiglitazar/Metformin extended-release tablets after a high-fat meal
Druga single dose of Chiglitazar/Metformin extended-release tablets after a high-fat meal
multiple-dose of Chiglitazar/Metformin extended-release tablets
Druga single dose on Day 1, once-daily consecutive doses from Day 4 to Day 10
FE Study: Maximum plasma concentration (Cmax)
FE Study: Area Under the Plasma Concentration-Time Curve (AUC)
FE Study: Time to Maximum Plasma Concentration（Tmax）
FE Study: Elimination Half-life （t1/2）
Incidence of Adverse Events (AEs)
Change from baseline in hematology parameters: white blood cell count, neutrophil count, lymphocyte count, monocyte count, eosinophil count, basophil count, red blood cell count , hemoglobin, hematocrit, platelet count
Change from baseline in hematology parameters: white blood cell count (WBC), neutrophil count, lymphocyte count, monocyte count, eosinophil count, basophil count, red blood cell count (RBC), hemoglobin (Hb), hematocrit (HCT), platelet count (PLT)
Changes from baseline in serum chemistry parameters
Changes from baseline in serum chemistry parameters: fasting blood glucose (FBG), total protein, albumin, total bilirubin, direct bilirubin, alanine aminotransferase (ALT), aspartate aminotransferase (AST), total cholesterol, triglycerides, high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), blood urea nitrogen (BUN) or urea, uric acid, creatinine, potassium (K⁺), sodium (Na⁺), chloride (Cl-), creatine kinase (CK)
Changes from baseline in urinalysis parameters: urine protein, urine ketones, urine glucose, urine pH, urine leukocytes, urine red blood cells
Changes from baseline in urinalysis parameters: urine protein, urine ketones, urine glucose, urine pH, urine leukocytes, urine red blood cells (RBCs)
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