Crossover Study to Evaluate the Comparative Bioavailability of Two Fixed Dose Combination Tablet Formulations of Amlodipine and Losartan in Health Volunteers

Hypertension Clinical Trial

Official title:
An Open-label, Randomized, Single Dose, Three-way Crossover Study to Determine the Comparative Bioavailability of Two Fixed Dose Combination Tablet Formulations of Amlodipine (5mg) and Losartan (100mg) in Healthy Adult Male and Female Subjects Under Fasting Conditions

Status Completed

Clinical Trial Summary

The purpose of this study is to evaluate the comparative bioavailability of two fixed dose combination tablet formulations of amlodipine and losartan in healthy volunteers. Subjects will receive each of the following three treatments administered in a randomized three-way crossover design: a reference treatment consisting of a 5mg amlodipine tablet and 100mg losartan tablet; a fixed dose combination tablet consisting of 5mg amlodipine and 100mg losartan; and another fixed dose combination tablet consisting of 5mg amlodipine and 100mg losartan; all three treatments will be administered once orally and in a fasted state. Serial blood samples will be obtained at pre-defined timepoints for pharmacokinetic analysis of amlodipine, losartan and carboxylic acid (this is the primary active losartan metabolite). Safety assessments will include measurements of orthostatic vital signs, electrocardiograms (ECG), collection of adverse events (AE) and clinical laboratory tests.

Clinical Trial Description

Amlodipine and losartan are calcium channel and angiotensin II receptor type-1 blockers, respectively, and are established treatments to manage blood pressure (BP) levels for patients with hypertension; both medications are currently marketed in the United States and Europe as anti-hypertensive agents. This is a an open-label, randomized, single dose, three-way crossover study enrolling 24 healthy adult male and female subjects under fasting conditions. Each subject will participate in three treatment periods. The study consists of a screening phase, three treatment periods and a follow-up visit. Subjects will receive each of the following three treatments administered in a randomized three-way crossover design: a reference treatment consisting of a single 5mg amlodipine tablet and a single 100mg losartan tablet; a single fixed dose combination tablet consisting of 5mg amlodipine and 100mg losartan; and another single fixed dose combination tablet consisting of 5mg amlodipine and 100mg losartan; all three treatments will be administered once orally and in a fasted state. Serial blood samples will be obtained at pre-defined timepoints for pharmacokinetic analysis of amlodipine, losartan and carboxylic acid (this is the primary active losartan metabolite). Safety assessments will include measurements of orthostatic vital signs, electrocardiograms (ECG), collection of adverse events (AE) and clinical laboratory tests. ;

Study Design

Related Conditions & MeSH terms

Hypertension

Clinical Trial Details

NCT number	NCT01648231
Study type	Interventional
Source	GlaxoSmithKline
Contact
Status	Completed
Phase	Phase 1
Start date	August 6, 2012
Completion date	September 25, 2012

View Details

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