Drug Interaction Between Irbesartan and Hydrochlorothiazide

Damanhour University

Status: Completed

Conditions: Healthy

Treatments: Drug: Hydrochlorothiazide; Drug: Irbeasartan/hydrochlorothiazide; Drug: Irbesartan

Study type: Interventional

Funder types: Other

Identifiers

NCT01858610

PPT4

Details and patient eligibility

About

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

Enrollment: 18 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

18 participants in 3 patient groups

Irbesartan alone

Other group

Description:

Irbesartan 300 mg alone

Treatment:

Drug: Irbesartan

Hydrochlorothiazide 25 mg alone

Other group

Description:

Hydrochlorothiazide 25 mg alone

Treatment:

Drug: Hydrochlorothiazide

Irbesartan 300 mg + Hydrochlorothiazide 25 mg

Other group

Description:

Irbesartan 300 mg + Hydrochlorothiazide 25 fixed dose combination

Treatment:

Drug: Irbeasartan/hydrochlorothiazide