Drug-Drug Interaction Study of Chiglitazar in Healthy Subjects.

• Status: Not yet recruiting
• Trial end date: 2023-03-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Chipscreen Biosciences, Ltd.
• Treatments: Atorvastatin; Empagliflozin; Valsartan

Criteria

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 infection history 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.