Drug Interaction Between Irbesartan and Hydrochlorothiazide

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2013-04-30

Brief Summary

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This study was conducted to investigate any potential reaction between irbesartan and hydrochlorothiazide.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

NONE

Study Groups

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Irbesartan alone

Irbesartan 300 mg alone

Group Type OTHER

Irbesartan

Intervention Type DRUG

Hydrochlorothiazide 25 mg alone

Group Type OTHER

Hydrochlorothiazide

Intervention Type DRUG

Irbesartan 300 mg + Hydrochlorothiazide 25 mg

Irbesartan 300 mg + Hydrochlorothiazide 25 fixed dose combination

Group Type OTHER

Irbeasartan/hydrochlorothiazide

Intervention Type DRUG

Interventions

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Irbeasartan/hydrochlorothiazide

Intervention Type DRUG

Irbesartan

Intervention Type DRUG

Hydrochlorothiazide

Intervention Type DRUG

Other Intervention Names

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Fixed dose combination

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes