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

CGZ110

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.

2023-02-17

2023-03-21

2023-03-21

Completed

Early phase I

48

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'CROSSOVER', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 48, 'type': 'ACTUAL'}}

2023-06-15