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

Phase 1

Completed

• Conditions: Cachexia; Anorexia
• Interventions: Drug: Megace F; Drug: Megace OS

• Registration Number: NCT01397214
• Lead Sponsor: Boryung Pharmaceutical Co., Ltd

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2011-07
• Study First Submitted: 2011-07-15
• Study First Submitted QC: 2011-07-18
• Study First Posted: 2011-07-19
• Primary Completion: 2011-09
• Study Completion: 2012-01
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-29
• Last Update Posted: 2012-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 103

Inclusion Criteria

age: 20-55 years body weight: greater than 50kg written informed consent

Exclusion Criteria

known allergy to Megesterol acute or chronic diseases which could affect drug absorption or metabolism positive drug or alcohol screening smokers of 10 or more cigarettes per day 3 month ago participation in a clinical trial during the last 3 months prior to the start of the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Megace F	Megace F	Megace F oral suspension
Megace OS	Megace OS	Megace acetate oral suspension

Primary Outcome Measures

Name	Time	Method
AUC	0, 1, 2,3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120 hrs

Secondary Outcome Measures

Name	Time	Method
Tmax	0, 1, 2,3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120 hrs
t1/2	0, 1, 2,3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120 hrs

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of