NCT01845272Unknown1 期
Open-label, Randomized, Single-dose, Crossover Study to Evaluate the Pharmacokinetic Interactions of Candesartan Cilexetil and Amlodipine Besylate in Healthy Male Volunteers.
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 入组人数
- 40
- 主要终点
- Assessment of the drug-drug interactions of candesartan and amlodipine
研究概览
简要总结
This study is designated to evaluate the pharmacokinetic interactions of candesartan cilexetil and amlodipine besylate 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
- Basic Science
- 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 mass index (BMI) in the range of 18.5 to 27 kg/m2(inclusive)
- •Available for the entire study period
- •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 outside the range of 100 to 150 mmHg or diastolic blood pressure outside the range of 60 to 1000 mmHg for male subjects. when screening period
- •Subject with symptoms of acute disease within 14days prior to study medication dosing
- •Subjects with a history of clinically significant allergies
- •Subjects with a hereditary problems, for example, galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
- •Subjects whose clinical laboratory test values are outside the accepted normal range(Especially,AST or ALT >1.5 times to normal range or total bilirubin > 1.5times to normal range)
- •History of drug abuse
- •History of caffeine, alcohol, smoking abuse
- •caffeine(coffee,tea,coke) or grapefruit juice > 4cups/day
- •smoking > 20 cigarettes/day
- •alcohol > 140g/week
- •Positive test results for HBs Ab, HCV Ab, Syphilis regain test
- •Participation in any clinical investigation within 30days prior to study medication dosing
- •Subjects with whole blood donation within 60days, component blood donation within 30days and blood transfusion within 30days prior to study medication dosing
- •Subjects considered as unsuitable based on medical judgement by investigators
研究组 & 干预措施
Part 1
Experimental
single administration : candesartan cilexetil 32mg, qd, 10days(oral).
combination administration : candesartan cilexetil 32mg and amlodipine 10mg, qd, 10days(oral).
干预措施: candesartan cilexetil 32mg, amlodipine 10mg (Drug)
Part 2
Experimental
single administration : amlodipine 10mg, qd, 10days(oral).
combination administration : candesartan cilexetil 32mg and amlodipine 10mg, qd, 10days(oral).
干预措施: candesartan cilexetil 32mg, amlodipine 10mg (Drug)
结局指标
主要结局
Assessment of the drug-drug interactions of candesartan and amlodipine
时间窗: 10 days
次要结局
未报告次要终点
研究者
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