NCT01397214

Pharmacokinetics of Megace F and Megace OS Under Fasting and Fed Conditions in Healthy Male Volunteers

A Randomized, Open-label, Single-dose, Cross-over Study to Investigate Safety and Pharmacokinetics of Megace F and Megace OS Under Fasting and Fed Conditions in Healthy Male Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 103 (actual)
• Sponsor: Boryung Pharmaceutical Co., Ltd · Industry
• Sex: Male
• Age: 20 Years – 55 Years
• Healthy volunteers: Accepted

Summary

Phase I study of Megace F will be conducted to investigate pharmacokinetics and safety compared to Megace OS. Phase I study divided into 3 parts written as belows. Part 1 Megace F in fasting volunteers vs Megace F in fed volunteers Part 2 Megace F vs Megace OS in fed volunteers Part 3 Megace F vs Megace OS in fasting volunteers

Conditions

• Cachexia
• Anorexia

Interventions

Type	Name	Description
DRUG	Megace F	Megace F oral suspension
DRUG	Megace OS	Megace oral suspension

Timeline

• Start date: 2011-07-01
• Primary completion: 2011-09-01
• Completion: 2012-01-01
• First posted: 2011-07-19
• Last updated: 2012-07-02

Locations

1 site across 1 country: South Korea