Pharmacokinetic Interactions of Losartan and Hydrochlorothiazide

Not Applicable

Completed

• Conditions: Healthy Normotensive Participants
• Interventions: Drug: Losartan/hydrochlorothiazide; Drug: Hydrochlorothiazide; Drug: Losartan

• Registration Number: NCT01858623
• Lead Sponsor: Damanhour University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2013-02
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Status Verified: 2013-05
• Study First Submitted: 2013-05-12
• Study First Submitted QC: 2013-05-20
• 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 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
Losartan / Hydrochlorothiazide100 mg/25mg	Losartan/hydrochlorothiazide	Losartan / Hydrochlorothiazide100 mg/25mg fixed dose combination
hydrochlorothiazide 25 mg	Hydrochlorothiazide	hydrochlorothiazide 25 mg alone
Losartan 100 mg	Losartan	Losartan 100 mg alone

Primary Outcome Measures

Name	Time	Method
Heart rate	Participants will be followed for the duration of study, an expected average of 5 weeks.
Blood pressure	Participants will be monitored for the duration of study, an expected average of 5 weeks.
Pharmacokinetic parameter such as Cmax of losartan and hydrochlorothiazide	At the end of the study, after collection of all blood samples, an expected average of 4 weeks
Pharmacokinetic parameter such as AUC of losartan and hydrochlorothiazide	At the end of the study, after collection of all blood samples, an expected average of 4 weeks