An Open-label, Multiple-dose, Two-arm Clinical Study to Evaluate the Drug-drug Interaction and Safety of Telmisartan, Amlodipine and/or Chlorthalidone in Healthy Adult Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- AUCt ss, Cmax ss of telmisartan/amlodipine/chlorthalidone
研究概览
简要总结
To evaluate Drug-drug interaction
详细描述
The purpose of this study is to evaluate the Drug-Drug(telmisartan, amlodipine and/ or chlorthalidone) interaction and safety in healthy adult 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 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participant who has a body weight that is ≥55kg(male) or ≥50kg(female) with ideal body weight of 80-120% (ideal body weight)
- •Who has not suffered from clinically significant disease
- •Provision of signed written informed consent
排除标准
- •History of and clinically significant disease psychiatric, or malignancy.
- •A history of drug abuse or the presence of positive reactions to drugs that have abuse potential in urine screenings for drugs.
- •Administration of other investigational products within 3 months prior to the first dosing.
- •Administration of herbal medicine within 2 weeks or administration of ethical drugs within 2 weeks or administration of over-the-counter (OTC) drugs within 1 week prior to the first dosing of the investigational product (if the investigator (study doctor) determines that the person meets other criteria appropriately, the relevant person may participate in the study).
- •Volunteers considered not eligible for the clinical trial by the investigator (study doctor) due to reasons including laboratory test results, ECGs, or vital signs.
研究组 & 干预措施
Part A
Arm to evaluate influence of amlodipine and telmisartan on pharmacokinetics of Chlorthalidone.
干预措施: Chlorthalidone (Drug)
Part B
Arm to evaluate influence of Chlorthalidone on pharmacokinetics of amlodipine and telmisartan.
干预措施: Telmisartan (Drug)
Part B
Arm to evaluate influence of Chlorthalidone on pharmacokinetics of amlodipine and telmisartan.
干预措施: Amlodipine (Drug)
Part B
Arm to evaluate influence of Chlorthalidone on pharmacokinetics of amlodipine and telmisartan.
干预措施: Chlorthalidone (Drug)
Part A
Arm to evaluate influence of amlodipine and telmisartan on pharmacokinetics of Chlorthalidone.
干预措施: Telmisartan (Drug)
Part A
Arm to evaluate influence of amlodipine and telmisartan on pharmacokinetics of Chlorthalidone.
干预措施: Amlodipine (Drug)
结局指标
主要结局
AUCt ss, Cmax ss of telmisartan/amlodipine/chlorthalidone
时间窗: Totally 28points for 24 hours
次要结局
- Cmin ss, tmax ss, t1/2 of telmisartan/amlodipine/chlorthalidone(Totally 28points for 24 hours)