NCT01926652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 Amlodipine 10mg and Candesartan 32mg in Healthy Male Volunteers
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- AUC, Cmax
研究概览
简要总结
Clinical trial to evaluate the pharmacokinetic interactions and safety between single dose of amlodipine 10mg and candesartan 32mg and the combination dose amlodipine 10mg with candesartan 32mg in healthy male volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Male volunteers in the age between 20 and 55 years old(inclusive).
- •Body weight >= 55kg and Body mass index (BMI) in the range of calculated IBW ±20%.
- •Subjects without a hereditary problems or chronic desease.
- •Subjects whose clinical laboratory test values are inside the accepted normal range.
- •Understand the requirements of the study and voluntarily consent to participate in the study.
排除标准
- •Subjects with a history of gastrointestinal diseases which might significantly change ADME of medicines.
- •Systolic blood pressure range ≥150 mmHg or ≤ 100 mmHg or diastolic blood pressure range ≥ 95 mmHg or ≤ 60 mmHg.
- •Subject with symptoms of acute disease within 14days prior to study medication dosing.
- •Subjects with a history of clinically significant allergies of amlodipin or candesartan or CCB or other medicine (ex. aspirin or antibiotics).
- •Subjects with galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.
- •Serum creatinine > 1.2mg/dL.
- •smoking > 10 cigarettes/day.
- •alcohol > 210g/week.
- •Positive test results for drug test in urin or subject with history of substance abuse.
- •Participation in any clinical investigation within 2 months prior to study medication dosing.
- •Subjects with whole blood donation within 2 months, component blood donation within 1 month and blood transfusion within 1 month prior to study medication dosing.
- •Subjects considered as unsuitable based on medical judgement by investigators.
研究组 & 干预措施
candesartan
Experimental
Single administration : candesartan cilexetil 32mg, qd. Combination administration : candesartan cilexetil 32mg and amlodipine 10mg, qd
干预措施: candesartan cilexetil 32mg, amlodipine 10mg (Drug)
amlodipine
Experimental
Single administration : amlodipine 10mg, qd. Combination administration : candesartan cilexetil 32mg and amlodipine 10mg, qd
干预措施: candesartan cilexetil 32mg, amlodipine 10mg (Drug)
结局指标
主要结局
AUC, Cmax
时间窗: 7days, 10days
次要结局
- Cmin, tmax, CL/F(7days, 10days)
研究者
研究点 (1)
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