Pharmacokinetic Interactions of Losartan and Hydrochlorothiazide (PKLH)

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

Study Overview

• Status: Completed
• Conditions: Healthy Normotensive Participants
• Intervention / Treatment: Drug: Losartan; Drug: Hydrochlorothiazide; Drug: Losartan/hydrochlorothiazide

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Losartan / Hydrochlorothiazide100 mg/25mg; Losartan / Hydrochlorothiazide100 mg/25mg fixed dose combination	Drug: Losartan/hydrochlorothiazide
Other: Losartan 100 mg; Losartan 100 mg alone	Drug: Losartan
Other: hydrochlorothiazide 25 mg; hydrochlorothiazide 25 mg alone	Drug: Hydrochlorothiazide

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Damanhour University

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (Actual): March 1, 2013
• Study Completion (Actual): March 1, 2013

Study Registration Dates

• First Submitted: May 12, 2013
• First Submitted That Met QC Criteria: May 20, 2013
• First Posted (Estimate): May 21, 2013

Study Record Updates

• Last Update Posted (Estimate): May 27, 2013
• Last Update Submitted That Met QC Criteria: May 24, 2013
• Last Verified: May 1, 2013

More Information

Terms related to this study

• Keywords: Pharmacokinetics; Losartan; Fixed dose combination; Hydrochlorothiazide; Healthy Normotensive Participants
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Antihypertensive Agents; Natriuretic Agents; Membrane Transport Modulators; Diuretics; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists; Sodium Chloride Symporter Inhibitors; Losartan; Hydrochlorothiazide
• Other Study ID Numbers: PPT5