NCT02254447

Relative Bioavailability Study of Candesartan Cilexetil Under Fasting Conditions

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Cardiovascular Disease

Interventions

Type	Name	Description
DRUG	Candesartan Cilexetil in formulation 1	Round, biconvex white tablets containing Candesartan cilexetil 16 mg for oral administration
DRUG	Candesartan Cilexetil in formulation 2	Round, biconvex white tablets containing Candesartan cilexetil 16 mg for oral administration
DRUG	ATACAND	Round, biconvex pink tablets containing Candesartan cilexetil 16 mg for oral administration

Timeline

• Start date: 2014-12-02
• Primary completion: 2015-01-08
• Completion: 2015-01-08
• First posted: 2014-10-01
• Last updated: 2018-03-12

Locations

1 site across 1 country: India