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Relative Bioavailability Study of Candesartan Cilexetil Under Fasting Conditions

Cardiovascular Disease Clinical Trial

Official title:
An Open-label, Randomized, Single Dose, Three-way Crossover, Six Sequence Pilot Study to Determine the Relative Bioavailability of Candesartan Cilexetil 16mg From Two Candidate Tablet Formulations of GW615775 Relative to One 16mg Tablet of Reference Candesartan Cilexetil in Healthy Adult Human Subjects Under Fasting Conditions

Clinical Trial Summary

This study will investigate the relative bioavailability of two candidate tablet formulations of 16 milligram (mg) Candesartan cilexetil (GW615775) compared with the reference product ATACAND™ containing 16 mg Candesartan cilexetil in healthy human subjects. This is an open-label, randomized, single dose, three-way crossover, six sequence study enrolling 18 healthy human subjects to ensure at least 14 subjects complete the study as planned. Each subject enrolled will participate in all three treatment periods and will be assigned to one of the six treatment sequences, in accordance with the randomization schedule. The treatment periods will be separated by a washout period of at least 7 days and no more than 14 days between dosing occasions. A follow up visit will be conducted 14-21 days post last dosing. ATACAND is a registered trademark of the AstraZeneca group of companies.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02254447
Study type Interventional
Source GlaxoSmithKline
Contact
Status Completed
Phase Phase 1
Start date December 2, 2014
Completion date January 8, 2015
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