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This is a pilot bioequivalence study. It is a randomized, open-label, single-dose, crossover study. The primary objective of this study is to preliminarily evaluate the pharmacokinetic parameters and their variability of the test formulation versus the reference formulation following a single oral dose under fed conditions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Sequence T-R (dose 1) | Experimental | Participants will receive treatment T (Chiglitazar/Metformin extended-release fixed dose combination tablets) on Day 1 followed by treatment R (Chiglitazar tablets and Metformin extended-release tablets) on Day 8. |
|
| Treatment Sequence R-T (dose 1) | Experimental | Participants will receive treatment R (Chiglitazar tablets and Metformin extended-release tablets) on Day 1 followed by treatment T (Chiglitazar/Metformin extended-release fixed dose combination tablets) on Day 8. |
|
| Treatment Sequence T-R (dose 2) | Experimental | Participants will receive treatment T (Chiglitazar/Metformin extended-release fixed dose combination tablets) on Day 1 followed by treatment R (Chiglitazar tablets and Metformin extended-release tablets) on Day 8. |
|
| Treatment Sequence R-T (dose 2) | Experimental | Participants will receive treatment R (Chiglitazar tablets and Metformin extended-release tablets) on Day 1 followed by treatment T (Chiglitazar/Metformin extended-release fixed dose combination tablets) on Day 8. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| treatment T (dose 1) | Drug | Chiglitazar/Metformin extended-release fixed dose combination tablets (dose 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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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| treatment T (dose 2) | Drug | Chiglitazar/Metformin extended-release fixed dose combination tablets (dose 2) |
|
| treatment R (dose 1) | Drug | Chiglitazar tablets and Metformin extended release tablets (dose 1) |
|
| treatment R (dose 2) | Drug | Chiglitazar tablets and Metformin extended release tablets (dose 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 |
| safety assessments: Incidence of Adverse Events (AEs) | up to Day 13 |
| Changes from baseline in laboratory safety parameters (including hematology, serum chemistry, coagulation, and urinalysis) | up to Day 11 |
| D004700 | Endocrine System Diseases |