A Fixed Dose Combination Amlodipine + Enalapril Bioavailability Study

Status Completed

Clinical Trial Summary

The study is designed to estimate the bioavailability of amlodipine and enalapril maleate fixed dose combination (FDC) relative to co-administration of amlodipine and enalapril maleate tablets. The rational for this study is to provide a more convenient dosing regimen for patients. This is an open-label, randomized, single dose, two-way crossover study, in which 16 healthy adult male and female subjects will be enrolled and dosed under fasting conditions. Each subject will participate in two treatment periods of 7 days each. There will be at least 14 days of wash out period between the two dosing periods and a follow-up period of up to 21 days after treatment period 2. The total duration of study will be approximately 35 days from the start of the first treatment.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Hypertension

Clinical Trial Details

NCT number	NCT01822639
Study type	Interventional
Source	GlaxoSmithKline
Contact
Status	Completed
Phase	Phase 1
Start date	April 3, 2013
Completion date	May 24, 2013

View Details

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