NCT02064621已完成1 期
A Randomized, Open-label, Multiple Doses, Crossover Study to Evaluate a Pharmacokinetic Drug Interaction and Safety of Candesartan Between Free Combination of Candesartan and Amlodipine and Candesartan Monotherapy 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
- 24
- 试验地点
- 1
- 主要终点
- AUCτ,ss of Candesartan
研究概览
简要总结
The purpose of this study is to evaluate a pharmacokinetic drug interaction and safety of Candesartan between free combination of Candesartan and Amlodipine and Candesartan monotherapy.
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
- •Healthy male volunteer is between 20 and 45 years of age(inclusive) at the pre-study(screening).
- •Volunteer who has 19kg/m² ≤ BMI(Body Mass Index) ≤ 26kg/m²
- •When volunteer in screening, Must include under the items.
- •100 mmHg ≤ sitting SBP <140 mmHg
- •60 mmHg ≤ sitting DBP < 90 mmHg
- •45 bpm ≤ Pulse < 95 bpm
- •Those who decided to join the clinical trials by themselves and to comply with the precautions written consent.
排除标准
- •A previous history or present of clinically significant liver, renal, gastro-intestinal, pulmonary, musculoskeletal, endocrine, neuropsychiatric, hemato-oncological, cardiovascular disease.
- •Have a gastrointestinal disease history that can affect drug absorption(Crohn's disease, Ulcers, GERD, Gastritis, etc.) or surgery (except simple appendectomy or hernia surgery).
- •The history of clinically significant hypersensitivity reaction about Investigational drugs and foods.
- •The history of drug abuse or drug abuse showed a positive for urine drug test.
- •Taking drugs have received any other investigational drug within 90 days prior to the first dosing and metabolizing enzyme inducers or inhibitors such as barbitals within 30 days prior to the first dosing.
- •Whole blood donation within 60 days prior to the first dosing or plasma donation within 30 days prior to the first dosing.
- •Taking drugs that clinical trials expected to affect within 14days or taking food containing caffeine, grapefruit within 7days before the first dosing.
- •A heavy alcohol consumer(alcohol>3cup/day or 3times/week within last 1month)
- •A heavy smoker(cigarette>10cigarettes/day)
- •The subject has positive results of serum tests(Hepatitis B, C, HIV Test, Syphilis).
- •Have the Liver enzyme levels(AST, ALT) or Bilirubin, total results greater than 1.5 times the UNL.
- •Have the result of Creatinine clearance is less than 80mL/min(Cockcroft-Gault equation applicable).
- •The result of 12-lead ECG in screening test is QTc>450msec.
- •An impossible one who participants in clinical trial by investigator's decision including laboratory test result or another reason.
研究组 & 干预措施
C(Candesartan 32mg)
Experimental
Candesartan 32mg 1T, PO, QD for 9days
干预措施: Candesartan 32mg/Amlodipine 10mg (Drug)
B(Candesartan 32mg/Amlodipine 10mg)
Experimental
Candesartan 32mg 1T, PO, QD for 9days/Amlodipine 10mg 1T, PO, QD for 9days
干预措施: Candesartan 32mg (Drug)
结局指标
主要结局
AUCτ,ss of Candesartan
时间窗: 1D 0h, 8D 0h, 9D 0h, 1h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 10h, 12h, 10D 0h, 11D 0h
Cmax,ss of Candesartan
时间窗: 1D 0h, 8D 0h, 9D 0h, 1h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 10h, 12h, 10D 0h, 11D 0h
次要结局
- Tmax,ss of Candesartan(1D 0h, 8D 0h, 9D 0h, 1h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 10h, 12h, 10D 0h, 11D 0h)
研究者
研究点 (1)
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