Clinical Trial to Evaluate the Influence of Genotype of Drug Metabolizing Enzyme or Transporter and Drug-drug Interactions of Aspirin Co-administration on the PK/PD of Clopidogrel and PK of Digoxin in Healthy Volunteers
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- AUC and Cmax of Clopidogrel and Digoxin
研究概览
简要总结
Clinical trial to evaluate the influence of multiple aspirin administration on PK and PD of co-administered drugs
详细描述
Clinical trial to evaluate the influence of genotype of drug metabolizing enzyme or transporter and drug-drug interactions of aspirin co-administration on the pharmacokinetics / pharmacodynamics of clopidogrel and pharmacokinetics of digoxin in healthy volunteers
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male subjects aged 20 - 45 years.
- •A body weight in the range of 50 kg (inclusive) - 90 kg (exclusive) and a body mass index (BMI) in the range 18.5 kg/m2 (inclusive) - 27 kg/m2 (inclusive).
- •Sufficient ability to understand the nature of the study and any hazards of participating in it. Provide written informed consent after being fully. informed about the study procedures.
排除标准
- •Presence or history of hypersensitivity or allergic reactions to drugs including investigational product (clopidogrel, digoxin or aspirin)
- •Clinically relevant abnormal medical history that could interfere with the objectives of the study.
- •A subject with history of gastrointestinal disease or surgery (except simple appendectomy or repair of hernia), which can influence the absorption of the study drug.
- •A subject whose lab test results are as follows; Platelet count or PT, aPTT < 0.9 x lower limit of reference range of > 1.1 x upper limit of reference range.
- •A subject whose SBP is over 160 mmHg or below 90 mmHg and DBP is over 100 mmHg or below 50 mmHg.
- •Clinically significant abnormal findings of ECG during screening test.
- •Presence or history of drug abuse or positive result in urine drug screening test.
- •Participation in other clinical trial within 2 months before first dose.
- •Use of CYP inducer (ex. rifampin) within 4 weeks before first dose.
- •Use of a prescription medicine, herbal medicine within 2 weeks or over-the-counter medication or vitamin substances within 1 week before first dose.
- •Use of grapefruit juice within 1 week before first dose.
- •Blood donation during 2 months or apheresis during 1 month before the study.
- •Use of alcohol over 21 units/weeks
- •Smoking of more than 10 cigarettes/days within 3 months before first dose.
- •Subject judged not eligible for study participation by investigator.
研究组 & 干预措施
Aspirin+Clopidogrel/Digoxin(oral)
Aspirin: Day 1 ~ Day 59(~65; till the EGC) Clopidogrel: Day -3, 26, 54 Digoxin: Day -2, 27, 55
干预措施: Aspirin+Clopidogrel/Digoxin(oral) (Drug)
Aspirin+Clopidogrel/Digoxin(IV)
Aspirin: Day 1 ~ Day 59(~65; till the EGC) Clopidogrel: Day -3, 26, 54 Digoxin: Day -2, 27, 55
干预措施: Aspirin+Clopidogrel/Digoxin(IV) (Drug)
结局指标
主要结局
AUC and Cmax of Clopidogrel and Digoxin
时间窗: pre- and post dose of Clopidogrel, Digoxin administration
(Clopidogrel)Predose and 10, 20, 30, 40, 50 min, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 h postdose on Week 0, 4, 8 (Digoxin) Predose and 10, 20, 30, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 h postdose on Week 0, 4, 8
次要结局
未报告次要终点