NCT01589562

Phase 1 Study of Daewon-ES(B) & Megace in Healthy Male Volunteers Under Fed Condition

A Randomized, Open Label, Single Dose, Cross-over, Phase I Trial to Investigate Safety and Pharmacokinetics of DW-ES(B) and Megace® Under Fed Conditions in Healthy Male Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (estimated)
• Sponsor: Daewon Pharmaceutical Co., Ltd. · Industry
• Sex: Male
• Age: 20 Years – 40 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate pharmacokinetics of Daewon DW-ES(B) 625mg/5ml and Megace 800mg/20ml in healthy male volunteers under fed condition.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Megace 800mg/20ml	Megestrol acetate 800mg/20ml, Suspension, Single dose
DRUG	DW-ES(B) 625mg/5ml	Megestrol acetate 625mg/5ml, Nano suspension, Single dose

Timeline

• Start date: 2012-04-01
• Primary completion: 2012-06-01
• Completion: 2012-06-01
• First posted: 2012-05-02
• Last updated: 2013-01-23

Locations

1 site across 1 country: South Korea