Drug-Drug Interaction Study to Investigate the Effect of Ketoconazole on the Pharmacokinetic Properties of CKD-501 in Healthy Male Volunteer: Open, Randomised, 2-way Crossover, Clinical Trial
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 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 effect of Ketoconazole on the pharmacokinetic characteristics of CKD-501 in healthy subject.
详细描述
From day 1 to day 5, Ketoconazole 200mg is administered twice daily to Group 1 patients during period 1. Then on day 5,CKD-501 0.5mg is co-administered Group 1 patients at period 1. After 28 day-break, period 2 will CKD-501 0.5mg administered on day 5. Period 2 will not Ketoconazole administered.
Group 2 is administered in reverse order.
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 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
- •18.5 ≤ IBW < 25
- •Agreement with written informed consent
排除标准
- •Hypersensitivity reactions to drugs or clinically significant hypersensitivity reactions in the history of party
- •Medication with drug-mediated induction/inhibition metabolic enzyme such as Midazolam within 1 month or with may affect the clinical trial
- •Subject has taken abnormal meals which affects the ADME of drug
- •Subject has a history(such as gastric or duodenal ulcer, gastrointestinal surgical histories except for an appendectomy) affects the ADME of drug
- •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
- •Previously participated in other trial within 60 days
- •Previously donate whole blood within 60 days or component blood within 30 days
- •Inadequate subject by medical examination(medical history, physical examination, ECG, laboratory test) within 28 days of starting administration of investigational drug
- •SBP >140 mmHg, SBP < 90 mmHg or DBP > 90 mmHg, DBP < 50 mmHg or Pulse > 100 per/min, Pulse < 50 per/min
- •12-lead ECG, QTc > 450 msec
- •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
Subjects received Ketoconazole 200 mg twice daily for 5 days in one period and in the other period, Subjects don't receive Ketoconazole.
In addition, The CKD-501 is administered on day 5
干预措施: CKD-501, Ketoconazole (Drug)
ketoconazole
Subjects received Ketoconazole 200 mg twice daily for 5 days in one period and in the other period, Subjects don't receive Ketoconazole.
In addition, The CKD-501 is administered on day 5
干预措施: CKD-501, Ketoconazole (Drug)
结局指标
主要结局
CKD-501 AUC
时间窗: 0(Day 5), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48hr
次要结局
- CKD-501 Cmax(0(Day 5), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48hr)
- CKD-501 Tmax(0(Day 5), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48hr)