Drug Interaction Between Irbesartan and Hydrochlorothiazide
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Blood pressure (systolic/diastolic)
研究概览
简要总结
This study was conducted to investigate any potential reaction between irbesartan 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 normotensive 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
Irbesartan alone
Irbesartan 300 mg alone
干预措施: Irbesartan (Drug)
Hydrochlorothiazide 25 mg alone
Hydrochlorothiazide 25 mg alone
干预措施: Hydrochlorothiazide (Drug)
Irbesartan 300 mg + Hydrochlorothiazide 25 mg
Irbesartan 300 mg + Hydrochlorothiazide 25 fixed dose combination
干预措施: Irbeasartan/hydrochlorothiazide (Drug)
结局指标
主要结局
Blood pressure (systolic/diastolic)
时间窗: participants will be followed for the duration of hospital stay, an expected average of 5 weeks
pharmacokinetic parameter such as the Cmax of irbesartan and hydrochlorothiazide
时间窗: 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 hospital stay, an expected average of 5 weeks
pharmacokinetic parameter such as the AUC of irbesartan and hydrochlorothiazide
时间窗: 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