NCT00791817

Study to Evaluate Potential Food Effects

An Open-label, Single Dose, Randomized, Crossover Study to Evaluate Potential Food Effects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Procter and Gamble · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

Half the group will be given a high fat diet and the other half will fast. They will then be crossed over.

Detailed description

A food-effect study which will be conducted at any time during the MRD study period on one single cohort of subjects using 200 mg oral dose of PG 760564. Half the group will be given a high fat diet and the other half will fast. They will ten be crossed over.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	PG-760564	200 mg capsule, single dose,fasted when dosed, duration is 4 days
DRUG	PG-760564	200 mg capsule, single dose,high fat diet when dosed, duration is 4 days

Timeline

• Start date: 2005-08-01
• Primary completion: 2006-01-01
• Completion: 2006-01-01
• First posted: 2008-11-17
• Last updated: 2011-09-07
• Results posted: 2011-09-07

Locations

1 site across 1 country: United States