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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence 1 of FE study | Experimental |
| |
| Sequence 2 of FE study | Experimental |
| |
| multiple-dose group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chiglitazar/Metformin extended-release tablets under fasting conditions | Drug | a single dose of Chiglitazar/Metformin extended-release tablets under fasting conditions |
|
| Measure | Description | Time Frame |
|---|---|---|
| FE Study: Maximum plasma concentration (Cmax) | Pre-dose and at multiple timepoints post-dose up to 72 hours | |
| FE Study: Area Under the Plasma Concentration-Time Curve (AUC) | Pre-dose and at multiple timepoints post-dose up to 72 hours | |
| FE Study: Time to Maximum Plasma Concentration(Tmax) | Pre-dose and at multiple timepoints post-dose up to 72 hours | |
| FE Study: Elimination Half-life (t1/2) | Pre-dose and at multiple timepoints post-dose up to 72 hours | |
| FE Study: Apparent Total Clearance (CL/F) | Pre-dose and at multiple timepoints post-dose up to 72 hours | |
| FE Study: Apparent Volume of Distribution during the terminal phase (Vz/F) | Pre-dose and at multiple timepoints post-dose up to 72 hours | |
| Multiple-dose PK study: Maximum plasma concentration (Cmax) | predose to 72 hours after the last dose (7 consecutive days of dosing) | |
| Multiple-dose PK Study: Area Under the Plasma Concentration-Time Curve (AUC) | predose to 72 hours after the last dose (7 consecutive days of dosing) | |
| Multiple-dose PK Study: Time to Maximum Plasma Concentration(Tmax) | predose to 72 hours after the last dose (7 consecutive days of dosing) |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Events (AEs) | up to Day 16 | |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Chiglitazar/Metformin extended-release tablets after a high-fat meal | Drug | a single dose of Chiglitazar/Metformin extended-release tablets after a high-fat meal |
|
| multiple-dose of Chiglitazar/Metformin extended-release tablets | Drug | a single dose on Day 1, once-daily consecutive doses from Day 4 to Day 10 |
|
| Multiple-dose PK Study: steady-state peak concentration (Cmax,ss) | predose to 72 hours after the last dose (7 consecutive days of dosing) |
| Multiple-dose PK Study: steady-state time to peak concentration (Tmax,ss) | predose to 72 hours after the last dose (7 consecutive days of dosing) |
| Multiple-dose PK Study: under the plasma concentration-time curve at steady state (AUCss) | predose to 72 hours after the last dose (7 consecutive days of dosing) |
| Multiple-dose PK Study: trough concentration (Ctrough) | predose to 72 hours after the last dose (7 consecutive days of dosing) |
| Multiple-dose PK Study: accumulation ratio (Rac) | predose to 72 hours after the last dose (7 consecutive days of dosing) |
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)
| up to Day 13 |
| 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) | up to Day 13 |
| 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) | up to Day 13 |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C515629 | chiglitazar |
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