Overview

Relative Bioavailability Study of Candesartan Cilexetil Under Fasting Conditions

Status:
Completed
Trial end date:
2015-01-08
Target enrollment:
Participant gender:
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 ATACANDâ„¢ 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.
Phase:
Phase 1
Details
Lead Sponsor:
GlaxoSmithKline
Treatments:
Candesartan
Candesartan cilexetil