NCT00536679

Relative Bioavailability and Food Effect Study for GSK163090 in Healthy Male and Female Volunteers

An Open Label, Randomised, Single Dose, Three-way Crossover Study to Investigate the Relative Bioavailability of Two Different Formulations of GSK163090 and the Effect of Food on the Pharmacokinetics of a Tablet Formulation in Healthy Male and Female Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The study will consist of a screening period, 3 treatment periods and a post-treatment follow-up. In each of the 3 treatment periods, subjects will receive a single oral dose of GSK163090 in the fed or fasted state, followed by a 7-day wash-out period between each dose

Conditions

• Depressive Disorder and Anxiety Disorders

Interventions

Type	Name	Description
DRUG	GSK163090 capsule, fasted	GSK163090 will be available as 1 mg hard gelatine white/white opaque capsules. Each subject will receive a single, oral dose of the study medication on the morning of Day 1. The study drug will be administered with approximately 240 milliliters (mL) of water.
DRUG	GSK163090 Tablet, fasted	GSK163090 will be available as 1 mg white coated round tablet. Each subject will receive a single, oral dose of the study medication on the morning of Day 1. The study drug will be administered with approximately 240 mL of water.
DRUG	GSK163090 Tablet, fed	GSK163090 will be available as 1 mg white coated round tablet. Each subject will receive a single, oral dose of the study medication on the morning of Day 1. The study drug will be administered with Food and Drug Administration (FDA) high fat breakfast.

Timeline

• Start date: 2007-09-20
• Primary completion: 2007-11-05
• Completion: 2007-11-05
• First posted: 2007-09-28
• Last updated: 2017-08-03

Locations

1 site across 1 country: Germany