Evaluation of the Pharmacokinetic Interaction Between Candesartan and Felodipine in a Combination Package Compared to the Separate Intake of the Reference Brands Atacand and Splendil After a Fasting Period.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Kinetic interaction evaluation of two test formulations of 16 mg of candesartan and 5 mg of felodipine after a fasting period and the comparison with the intake of both reference medicaments: Atacand® and Splendil®.
研究概览
简要总结
The purpose of this study is to evaluate the pharmacokinetic interaction of test formulations of candesartan and felodipine in a combination package comparing with the fasting intake of commercial formulations of both Atacand ® and Splendil®
研究设计
- 研究类型
- Interventional
- 干预模型
- Crossover
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers
- •BMI > or = 19 and < or = 28 (Dietary Guidelines Advisory Committee, 2005)
排除标准
- •Not healthy
- •Chronic drug intake
研究组 & 干预措施
Single-arm
3 treatments, 6 sequences, 3 periods, cross-over, single dose arm (Willians' Plan)
干预措施: Candesartan (test) (Drug)
Single-arm
3 treatments, 6 sequences, 3 periods, cross-over, single dose arm (Willians' Plan)
干预措施: Felodipine (test) (Drug)
Single-arm
3 treatments, 6 sequences, 3 periods, cross-over, single dose arm (Willians' Plan)
干预措施: Candesartan Cilexetil (Drug)
Single-arm
3 treatments, 6 sequences, 3 periods, cross-over, single dose arm (Willians' Plan)
干预措施: Felodipine (Drug)
结局指标
主要结局
Kinetic interaction evaluation of two test formulations of 16 mg of candesartan and 5 mg of felodipine after a fasting period and the comparison with the intake of both reference medicaments: Atacand® and Splendil®.
时间窗: 76 blood samples per subject
次要结局
未报告次要终点