Drug Interaction Between Irbesartan and Hydrochlorothiazide
研究概览
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Damanhour、埃及
- Pharmaceutics Department, Faculty of Pharmacy, Damanhour University
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
At least 18 years old and not more than 45 healthy normotensive male volunteers Who had passed all the screening parameters
Exclusion Criteria:
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
学习计划
研究是如何设计的？
设计细节
- 分配：随机化
- 介入模型：交叉作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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其他：Irbesartan alone
Irbesartan 300 mg alone
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其他：Hydrochlorothiazide 25 mg alone
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其他：Irbesartan 300 mg + Hydrochlorothiazide 25 mg
Irbesartan 300 mg + Hydrochlorothiazide 25 fixed dose combination
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其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Blood pressure (systolic/diastolic)
大体时间：participants will be followed for the duration of hospital stay, an expected average of 5 weeks
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participants will be followed for the duration of hospital stay, an expected average of 5 weeks
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pharmacokinetic parameter such as the Cmax of irbesartan and hydrochlorothiazide
大体时间：After collection of all blood samples, an expected average of 4 weeks
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After collection of all blood samples, an expected average of 4 weeks
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Heart rate
大体时间：participants will be followed for the duration of hospital stay, an expected average of 5 weeks
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participants will be followed for the duration of hospital stay, an expected average of 5 weeks
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pharmacokinetic parameter such as the AUC of irbesartan and hydrochlorothiazide
大体时间：After collection of all blood samples, an expected average of 4 weeks
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After collection of all blood samples, an expected average of 4 weeks
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合作者和调查者
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- PPT4
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.