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NCT05681273
Drug-Drug Interaction Study of Chiglitazar in Healthy Subjects.
Conditions: T2DM
Sex: All
Ages: 18 Years – 45 Years
Healthy volunteers: 1
Phase: PHASE1
Enrollment: 48
Sponsor: Chipscreen Biosciences, Ltd.
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.
Eligibility 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.
Source: ClinicalTrials.gov (NCT05681273). StuddyBuddy aggregates publicly available trial information.