Pharmacokinetic Interactions of Losartan and Hydrochlorothiazide
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 主要终点
- Pharmacokinetic parameter such as Cmax of losartan and hydrochlorothiazide
研究概览
简要总结
This study was conducted to investigate any potential reaction between losartan and hydrochlorothiazide.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •At least 18 years old and not more than 45 healthy male volunteers
- •Who had passed all the screening parameters
排除标准
- •A clinically significant abnormal physical exam, medical history, or laboratory studies
- •If they showed a sitting SBP of >140 or <100 mmHg, DBP > 90 or <60mm Hg, or a pulse rate of > 95 or < 50 beats/min at screening
- •The use of any prescription drug within the previous month or use of any over-the-counter medication within the past 14 days
- •A history of blood dyscrasias
- •A history of alcohol or drug abuse within the past year
- •Donation of blood during the 8 weeks prior to the study or plans to donate blood during or within 8 weeks of completing the study
- •Unable to tolerate vein puncture and multiple blood samplings
- •Any surgical/medical condition that might alter drug absorption, distribution, metabolism, or excretion
研究组 & 干预措施
Losartan / Hydrochlorothiazide100 mg/25mg
Losartan / Hydrochlorothiazide100 mg/25mg fixed dose combination
干预措施: Losartan/hydrochlorothiazide (Drug)
Losartan 100 mg
Losartan 100 mg alone
干预措施: Losartan (Drug)
hydrochlorothiazide 25 mg
hydrochlorothiazide 25 mg alone
干预措施: Hydrochlorothiazide (Drug)
结局指标
主要结局
Pharmacokinetic parameter such as Cmax of losartan and hydrochlorothiazide
时间窗: At the end of the study, after collection of all blood samples, an expected average of 4 weeks
Heart rate
时间窗: Participants will be followed for the duration of study, an expected average of 5 weeks.
Blood pressure
时间窗: Participants will be monitored for the duration of study, an expected average of 5 weeks.
Pharmacokinetic parameter such as AUC of losartan and hydrochlorothiazide
时间窗: At the end of the study, after collection of all blood samples, an expected average of 4 weeks
次要结局
未报告次要终点
研究者
Sally Helmy, PhD, CPHQ
Lecturer of Pharmaceutics, Faculty of Pharmacy
Damanhour University