A Randomized, Open-label, Multiple Dose, Three-treatment, Three-period, Six-sequence Crossover Clinical Trial to Investigate the Pharmacokinetic Drug Interaction Between CKD-501 and Amlodipine After Oral Administration in Healthy Male Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- CKD-501 AUC
研究概览
简要总结
The purpose of this study is to assess the pharmacokinetic drug interaction between CKD-501 and amlodipine after oral administration in healthy male volunteers.
详细描述
Volunteers doses three times over the period of CKD-501 0.5mg or Amlodipine 10mg alone/co-administrate, repeated doses are 10 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Between 20 aged and 45 years old in healthy males
- •Body weight ≥ 55kg and 18.5 ≤ IBW < 25
- •Agreement with written informed consent
排除标准
- •Subject has a history affects the ADME of drug
- •Hypersensitivity reactions to drugs or clinically significant hypersensitivity reactions in the history of party
- •Inadequate subject by medical examination(medical history, physical examination, ECG, laboratory test)
- •AST,ALT > UNL * 1.25 or Total bilirubin > UNL * 1.5
- •Estimated GFR(MDRD) < 80
- •SBP >150 mmHg, SBP < 100 mmHg or DBP > 100 mmHg, DBP < 60 mmHg or Pulse > 100 per/min, Pulse < 50 per/min
- •Substance abuse, or a history of drug abuse showed a positive for the party
- •Continued to be taking caffeine (caffeine > 5 cup/day), drinking (alcohol > 210 g/week) or cannot stop drinking or severe heavy smoker(cigarette > 10 cigarettes per day)during clinical trials
- •Medication with drug-mediated induction/inhibition metabolic enzyme within 30 days or with may affect the clinical trial
- •Medication within 2 weeks in the first professional medical, medicine, OTC, vitamins taking
- •Subject takes grapefruit within 1 month
- •Previously participated in other trial within 60 days
- •Previously donate whole blood within 60 days or component blood within 30 days
- •An impossible one who participates in clinical trial by investigator's decision including laboratory test result
研究组 & 干预措施
CKD-501 0.5mg
Subjects received CKD-501 0.5mg once daily for 10 days. Subjects received amlodipine 10mg once daily for 10 days. Subjects received CKD-501 0.5mg and amlodipine 10mg for 10 days.
干预措施: CKD-501 (Drug)
CKD-501 Amlodipine
Subjects received CKD-501 0.5mg once daily for 10 days. Subjects received amlodipine 10mg once daily for 10 days. Subjects received CKD-501 0.5mg and amlodipine 10mg for 10 days.
干预措施: CKD-501 amlodipine (Drug)
Amlodipine 10mg
Subjects received CKD-501 0.5mg once daily for 10 days. Subjects received amlodipine 10mg once daily for 10 days. Subjects received CKD-501 0.5mg and amlodipine 10mg for 10 days.
干预措施: amlodiopine (Drug)
结局指标
主要结局
CKD-501 AUC
时间窗: Pre dose(D8-9, D29-30, D50-51), 0, 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24hr
Amlodipine AUC
时间窗: Pre dose(D8-9, D29-30, D50-51), 0, 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 48, 72hr
次要结局
- CKD-5011 Tmax(Pre dose(D8-9, D29-30, D50-51), 0, 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24hr)
- Amlodipine Tmax(Pre dose(D8-9, D29-30, D50-51), 0, 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 48, 72hr)