A Phase I Study to Evaluate the Drug-Drug Interaction of Chiglitazar With Empagliflozin，Atorvastatin and Valsartan in Healthy Subjects.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Cmax
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Empagliflozin (Drug)
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.
干预措施: Chiglitazar (Drug)
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.
干预措施: Chiglitazar (Drug)
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.
干预措施: Atorvastatin (Drug)
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.
干预措施: Chiglitazar (Drug)
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.
干预措施: Valsartan (Drug)
结局指标
主要结局
Cmax
时间窗: up to 72 hours
Maximum plasma concentration
AUC0-t and AUC0-inf
时间窗: up to 72 hours
Area under of the curve (AUC0-t and AUC0-inf)
次要结局
未报告次要终点