Drug Interaction Between Irbesartan and Hydrochlorothiazide

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Drug: Irbeasartan/hydrochlorothiazide; Drug: Hydrochlorothiazide; Drug: Irbesartan

• Registration Number: NCT01858610
• Lead Sponsor: Damanhour University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03
• Primary Completion: 2013-04
• Study Completion: 2013-04
• Status Verified: 2013-05
• Study First Submitted: 2013-05-12
• Study First Submitted QC: 2013-05-16
• Study First Posted: 2013-05-21
• Last Update Submitted: 2013-05-24
• Last Update Posted: 2013-05-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 18

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Irbesartan 300 mg + Hydrochlorothiazide 25 mg	Irbeasartan/hydrochlorothiazide	Irbesartan 300 mg + Hydrochlorothiazide 25 fixed dose combination
Hydrochlorothiazide 25 mg alone	Hydrochlorothiazide	Hydrochlorothiazide 25 mg alone
Irbesartan alone	Irbesartan	Irbesartan 300 mg alone

Primary Outcome Measures

Name	Time	Method
Blood pressure (systolic/diastolic)	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	After collection of all blood samples, an expected average of 4 weeks
Heart rate	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	After collection of all blood samples, an expected average of 4 weeks

Trial Locations

Locations (1)

Pharmaceutics Department, Faculty of Pharmacy, Damanhour University; 🇪🇬 Damanhour, Egypt