A Phase I Study to Evaluate the Drug-Drug Interaction of Chiglitazar With Empagliflozin，Atorvastatin and Valsartan in Healthy Subjects.
Overview
- Phase
- Phase 1
- Intervention
- Empagliflozin
- Conditions
- T2DM
- Sponsor
- Chipscreen Biosciences, Ltd.
- Enrollment
- 48
- Locations
- 1
- Primary Endpoint
- Cmax
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Healthy male and female subjects between the ages of 18 and 45 years, inclusive;
- •19.0≤BMI≤26.0 kg/m
- •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;
Arms & Interventions
Group A
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.
Intervention: Empagliflozin
Group A
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.
Intervention: Chiglitazar
Group B
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.
Intervention: Chiglitazar
Group B
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.
Intervention: Atorvastatin
Group C
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.
Intervention: Chiglitazar
Group C
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.
Intervention: Valsartan
Outcomes
Primary Outcomes
Cmax
Time Frame: up to 72 hours
Maximum plasma concentration
AUC0-t and AUC0-inf
Time Frame: up to 72 hours
Area under of the curve (AUC0-t and AUC0-inf)