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This is a single-center, randomized, open-label, two-period, two-sequence crossover bioequivalence study under fed conditions. The primary objective is to evaluate the bioequivalence of a single oral dose of the test formulation compared with the reference formulation in the fed state.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence T-R (dose 1) | Experimental | Participants will receive Chiglitazar/Metformin extended-release fixed dose combination tablets at dose level 1 in Period 1 on Day 1, followed by Chiglitazar tablets and Metformin extended-release tablets at dose level 1 in Period 2 on Day 1. |
|
| Sequence R-T (dose 1) | Experimental | Participants receive chiglitazar tablet and metformin extended-release tablet at dose level 1 in Period 1 on Day 1, followed by chiglitazar/metformin extended-release fixed-dose combination tablet at dose level 1 in Period 2 on Day 1. |
|
| Sequence T-R (dose 2) | Experimental | Participants receive chiglitazar/metformin extended-release fixed-dose combination tablet at dose level 2 in Period 1 on Day 1, followed by chiglitazar tablet and metformin extended-release tablet at dose level 2 in Period 2 on Day 1. |
|
| Sequence R-T (dose 2) | Experimental | Participants receive chiglitazar tablet and metformin extended-release tablet at dose level 2 in Period 1 on Day 1, followed by chiglitazar/metformin extended-release fixed-dose combination tablet at dose level 2 in Period 2 on Day 1. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chiglitazar/Metformin extended-release fixed-dose combination tablet, dose 1 | Drug | Fixed-dose combination tablet containing chiglitazar and metformin extended-release, administered at dose level 1. |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum plasma concentration (Cmax) | Pre-dose and at multiple timepoints post-dose up to 72 hours | |
| Area Under the Plasma Concentration-Time Curve from time zero to the last measurable concentration (AUC0-last) | Pre-dose and at multiple timepoints post-dose up to 72 hours | |
| Area Under the Plasma Concentration-Time Curve from time zero to infinity (AUC0-∞) | Pre-dose and at multiple timepoints post-dose up to 72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Maximum Plasma Concentration(Tmax) | Pre-dose and at multiple timepoints post-dose up to 72 hours | |
| Elimination Half-life (t1/2) | Pre-dose and at multiple timepoints post-dose up to 72 hours |
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Inclusion Criteria:
Exclusion Criteria:
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|
| Chiglitazar tablet, dose 1 | Drug | Chiglitazar tablet administered as one of the reference treatment at dose level 1. |
|
| Metformin extended-release tablet, dose 1 | Drug | Metformin extended-release tablet administered as one of the reference treatment at dose level 1. |
|
| Chiglitazar/Metformin extended-release fixed-dose combination tablet, dose 2 | Drug | Fixed-dose combination tablet containing chiglitazar and metformin extended-release, administered at dose level 2. |
|
| Chiglitazar tablet, dose 2 | Drug | Chiglitazar tablet administered as one of the reference treatment at dose level 2. |
|
| Metformin extended-release tablet, dose 2 | Drug | Metformin extended-release tablet administered as one of the reference treatment at dose level 2. |
|
| Apparent Total Clearance (CL/F) | Pre-dose and at multiple timepoints post-dose up to 72 hours |
| Apparent Volume of Distribution during the terminal phase (Vz/F) | Pre-dose and at multiple timepoints post-dose up to 72 hours |
| Incidence of Adverse Events (AEs) | up to Day 11 |
| 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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