NCT00638079

Evaluating the Effect of Food on Absorption of Megace ES

Single-center, Randomized, Open-label, 2-way Crossover Bioavailability Study, Evaluating the Effect of Food on Megace ES (Megestrol Acetate 625 mg/5 mL Oral Suspension) Following a 625 mg Dose in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Endo Pharmaceuticals · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

To evaluate the effect of food on the rate and extent of absorption of megestrol acetate 625 mg/5 mL , and determine the safety and tolerability of megestrol acetate 625 mg/5 mL in healthy individuals.

Conditions

• Pharmacokinetics
• Bioavailability
• Absorption

Interventions

Type	Name	Description
DRUG	Megestrol acetate oral suspension 625 mg/5 mL	Megestrol acetate oral suspension 625 mg/5 mL. Single dose (5 mL) administered with a high fat meal
DRUG	Megestrol acetate oral suspension 625 mg/5 mL	Megestrol acetate oral suspension 625 mg/5 mL. Single dose (5 mL) administered following an overnight fast

Timeline

• Start date: 2006-06-01
• Primary completion: 2006-07-01
• Completion: 2006-07-01
• First posted: 2008-03-18
• Last updated: 2016-04-19

Locations

1 site across 1 country: Canada