A Two-cohort, Single-sequence, Parallel, Open Label, Multiple Oral Dosing Phase I Study to Evaluate the Safety and the Pharmacokinetic Drug-drug Interaction of Omega-3 and Atorvastatin in Healthy Male Volunteers
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Cohort A
研究概览
简要总结
This study evaluates the safety and pharmacokinetic drug-drug interactions of omega-3 and atorvastatin in healthy male volunteers. Half of the participants will receive omega-3 for 16 days to be steady state of omega-3 and followed by omega-3 and atorvastatin in combination for 7 days. The other half will receive Atorvastatin for 7 days to be steady state of Atorvastatin, and followed by Atorvastatin and Omega-3 in combination for 16 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •50kg or less of body weight and body mass index of 18 ~ 30kg/m²
- •No congenital or chronic disease requiring treatment, and no pathological symptoms or findings as a result of medical examination
- •Eligible for the clinical trial as a result of a clinical laboratory test, 12-lead ECG, V/S test at the screening
排除标准
- 未提供
研究组 & 干预措施
Cohort A
Administration of omacor soft capsule 4000mg for 16 days, and followed by omacor soft capsule 4000mg and Pritor tablet 40mg in combination for 7 days.
干预措施: Omacor (Drug)
Cohort A
Administration of omacor soft capsule 4000mg for 16 days, and followed by omacor soft capsule 4000mg and Pritor tablet 40mg in combination for 7 days.
干预措施: Omacor + Pritor (Drug)
Cohort B
Administration of Pritor tablet 40mg for 7 days, and followed by Pritor tablet 40mg and Omacor soft capsule 4000mg in combination for 16 days.
干预措施: Pritor (Drug)
Cohort B
Administration of Pritor tablet 40mg for 7 days, and followed by Pritor tablet 40mg and Omacor soft capsule 4000mg in combination for 16 days.
干预措施: Pritor + Omacor (Drug)
结局指标
主要结局
Cohort A
时间窗: Day 1 -20hours, -16hours, -12hours, 0hours, Day 13, 14, 15 0hours, Day 16 0, 1, 2, 3, 4, 6, 8, 12, 24hours, Day 23 0, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 14, 24hours
Area under curve(0-t) of EPA total lipid and Docosahexaenoic acid total lipid AUC t,ss and C max, ss of Atorvastatin
Cohort B
时间窗: Day 1 0hours, Day 5, 6 0hours, Day 7 0, 0.25 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12 ,24hours, Day 23 0, 0.25, 0.5, 0.75, 1, 1.25, 2, 3, 4, 6, 8, 12, 24hours
Area under curve(0-t) of Atorvastatin
次要结局
未报告次要终点