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This Phase 1 open label study is being conducted to characterize the pharmacokinetic (PK) and safety profiles of Chiglitazar with Empagliflozin,Atorvastatin and Valsartan in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | D1: Oral single dose of Empagliflozin 10 mg; D5~9: Oral multiple doses of Chiglitazar 48 mg; D10: Oral single dose of Empagliflozin 10 mg and Chiglitazar 48 mg. |
|
| Group B | Experimental | D1: Oral single dose of Atorvastatin 20 mg; D5~9: Oral multiple doses of Chiglitazar 48 mg; D10: Oral single dose of Atorvastatin 20 mg and Chiglitazar 48 mg. |
|
| Group C | Experimental | D1: Oral single dose of Valsartan 160 mg; D5~9: Oral multiple doses of Chiglitazar 48 mg; D10: Oral single dose of Valsartan 160 mg and Chiglitazar 48 mg. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chiglitazar | Drug | Chiglitazar 48mg |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | Maximum plasma concentration | up to 72 hours |
| AUC0-t and AUC0-inf | Area under of the curve (AUC0-t and AUC0-inf) | up to 72 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hongrong Xu | Shanghai Zhongshan Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan hospital | Shanghai | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42148367 | Derived | Sheng L, Li X, Yu J, Yang X, Li H, Xu H. Drug-Drug Interaction of Chiglitazar with Empagliflozin, Atorvastatin, and Valsartan: An Open-Label, Single-Center, Self-Control, 3-Period Study. Drug Des Devel Ther. 2026 May 8;20:588573. doi: 10.2147/DDDT.S588573. eCollection 2026. |
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| ID | Term |
|---|---|
| C515629 | chiglitazar |
| C570240 | empagliflozin |
| D000069059 | Atorvastatin |
| D000068756 | Valsartan |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Empagliflozin |
| Drug |
Empagliflozin 10mg |
|
| Atorvastatin | Drug | Atorvastatin 20mg |
|
| Valsartan | Drug | Valsartan 160mg |
|
| D006538 |
| Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D013777 | Tetrazoles |
| D014633 | Valine |
| D000597 | Amino Acids, Branched-Chain |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000601 | Amino Acids, Essential |