NCT02358824已完成1 期
A Phase I Clinical Trial to Compare the Pharmacokinetics and Safety of CKD-828(Telmisartan 80mg/S-amlodipine 5mg Combination Tablet) to Coadministration of Telmisartan 80mg and S-amlodipine 5mg 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
- 48
- 试验地点
- 1
- 主要终点
- Cmax after administration of CKD-828(Fixed Dose Combination) tablet and coadministration of corresponding dose of telmisartan and s-amlodipine.
研究概览
简要总结
A randomized, open-label, single-dose, four-period, two-way, crossover study,
详细描述
A randomized, open-label, single-dose, four-period, two-way, crossover study to compare the pharmacokinetics and safety CKD-828 (Fixed Dose Combination Tablet) to coadministration telmisartan and s-amlodipine in health 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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •A healthy volunteer over 20 years old
- •More than 50kg and within 20% of ideal body weight
- •No any congenital or chronic diseases and medical symptom
- •Appropriate for the study from examination(laboratory test, ECG etc.) within 4weeks prior to the first IP administration
- •Signed the informed consent form prior to the study participation.
排除标准
- •History of relevant hypersensitivity against drug
- •Clinical significant disease or medical history (ex. hepato/cholangio, cardio, endo, hemato, onco, CNS etc.)
- •Active liver disease or abnormal laboratory result (AST or ALT or Total bilirubin > 1.5*ULN)
- •SBP <90mmHg or SBP >150mmHg
- •DBP <50mmHg or DBP >100mmHg
- •Creatinine clearance <80mL/min
- •A Disease(ex.inflammatory intestinal disease, gastric or duodenal ulcer ,hepatic disease history , gastro-intestinal surgery except for appendectomy)that may influence on the absorption, distribution, metabolism and excretion of the drug
- •The evidence of severe attack or acute disease or surgical intervention within 28 days prior to the first IP administration.
- •A drug abuse or a heavy caffeine consumer (more than 5 cups per a day) or regular alcohol consumer(more than 21 units/week) or a heavy smoker(more than 10 cigarettes per a day)
- •Taking ETC medicine or oriental medicine within 14days or Taking OTC medicine within 7days prior to the first IP administration
- •Abnormal diet(Especially, grapefruit juice within 7 days prior to the first IP administration) that may influence on the absorption, distribution, metabolism and excretion of the drug
研究组 & 干预措施
CKD-828(Fixed Dose Combination)
Experimental
FDC tablet consisting of Telmisartan 80mg/S-Amlodipine 5mg
干预措施: CKD-828 (Drug)
Combination Therapy
Active Comparator
Coadministration of Telmisartan 80mg and S-amlodipine 5mg
干预措施: Telmisartan (Drug)
Combination Therapy
Active Comparator
Coadministration of Telmisartan 80mg and S-amlodipine 5mg
干预措施: S-amlodipine (Drug)
结局指标
主要结局
Cmax after administration of CKD-828(Fixed Dose Combination) tablet and coadministration of corresponding dose of telmisartan and s-amlodipine.
时间窗: up to 144 hours post dose
AUClast after administration of CKD-828(Fixed Dose Combination) tablet and coadministration of corresponding dose of telmisartan and s-amlodipine.
时间窗: up to 144 hours post dose
次要结局
- Tmax after administration of CKD-828(Fixed Dose Combination) tablet and coadministration of corresponding dose of telmisartan and s-amlodipine.(up to 144 hours post dose)
- t1/2 after administration of CKD-828(Fixed Dose Combination) tablet and coadministration of corresponding dose of telmisartan and s-amlodipine.(up to 144 hours post dose)
- AUCinf after administration of CKD-828(Fixed Dose Combination) tablet and coadministration of corresponding dose of telmisartan and s-amlodipine.(up to 144 hours post dose)
- Number of participants with adverse events(up to 59days post dose)
研究者
研究点 (1)
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