NCT02079506已完成1 期
An Open-label, Multiple-dosing, Two-arm, One-sequence, Crossover Study to Evaluate the Safety and Pharmacokinetics After Oral Concurrent Administration of Candesartan 32 mg and Rosuvastatin 20 mg in Healthy Male Volunteers
Alvogen Korea1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2014年2月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- AUCτ,ss of candesartan
研究概览
简要总结
The objective of this study is to compare pharmacokinetics after single oral administration of candesartan and rosuvastatin each separately versus coadministration of candesartan and rosuvastatin in healthy male volunteers.
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
- 20 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male volunteers af aged between 20 years to 45 years
- •Have a weight above 55kg and Ideal body weight (IBW) between -20% and +20% inclusive
- •Eligible subjects with acceptable medical history and physical examination
排除标准
- •Have a known hypersensitivity or history of clinically significant hypersensitivity to drugs including the same class drugs with candesartan or rosuvastatin, or other drugs
研究组 & 干预措施
Treatment A
Experimental
干预措施: Candesartan (Drug)
Treatment B
Experimental
干预措施: Rosuvastatin (Drug)
结局指标
主要结局
AUCτ,ss of candesartan
时间窗: 22 points
0h(pre-dose), 1, 2, 3, 4, 5, 6, 7, 8, 12 and 24 h
Cmax,ss of candesartan
时间窗: 22 points
0h(pre-dose), 1, 2, 3, 4, 5, 6, 7, 8, 12 and 24 h
AUCτ,ss of rosuvastatin
时间窗: 28 points
0(pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 9, 12 and 24 h
Cmax,ss of rosuvastatin
时间窗: 28 points
0(pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 9, 12 and 24 h
次要结局
- tmax,ss of candesartan(22 points)
- CLss/F of candesartan(22 points)
- tmax,ss of rosuvastatin(28 points)
- CLss/F of rosuvastatin(28 points)
- Cmin,ss of candesartan(22 points)
- Cmin,ss of rosuvastatin(28 points)
研究者
研究点 (1)
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