Drug-Drug Interaction Study of Chiglitazar in Healthy Subjects.

Study Overview
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Brief Summary
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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.

Official Title
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A Phase I Study to Evaluate the Drug-Drug Interaction of Chiglitazar With Empagliflozin，Atorvastatin and Valsartan in Healthy Subjects.

Conditions
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T2DM

Intervention / Treatment
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* Drug: Chiglitazar
* Drug: Empagliflozin
* Drug: Atorvastatin
* Drug: Valsartan


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male and female subjects between the ages of 18 and 45 years, inclusive; 19.0≤BMI≤26.0 kg/m2. Weight of male ≥50 kg and Weight of female ≥ 45 kg. Exclusion Criteria: History of clinically significant allergy or atopic allergic disease, or allergy to the study drug; Previous surgery may affect drug absorption, distribution, metabolism and excretion; or have suffered from gastrointestinal, liver and kidney diseases that can affect drug absorption or metabolism in the past 6 months; History of tuberculosis; Frequent infection history in the past year, or serious infections leading to hospitalization within 3 months before administration; untreated diarrhea, or diarrhea within 7 days before administration; Any drugs, vitamin products or herbal medicine used within 1 month before administration; History of drug abuse; Participated in clinical trial within 3 months before administration; Blood donation or massive blood loss within 3 months before the first administration; Pregnant or lactating women; Regular drinking history; or took any alcoholic products within 48 hours before administration; or positive alcohol test; Regular smoking history within 3 months before administration or cannot quit smoking during the trial; GFR<80 mL/min; Abnormal results of laboratory examination,vital signs, 12 lead ECG, physical examination and chest X-ray; Systolic blood pressure<90 or ≥ 140 mmHg, diastolic blood pressure<60 or ≥ 90 mmHg; Other situations that are not suitable for participate the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>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. | Drug: Chiglitazar<br>* Chiglitazar 48mg<br>Drug: Empagliflozin<br>* Empagliflozin 10mg<br>|
| Experimental: Group B<br>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. | Drug: Chiglitazar<br>* Chiglitazar 48mg<br>Drug: Atorvastatin<br>* Atorvastatin 20mg<br>|
| Experimental: Group C<br>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. | Drug: Chiglitazar<br>* Chiglitazar 48mg<br>Drug: Valsartan<br>* Valsartan 160mg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 |