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

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

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

Study Overview

• Status: Completed
• Conditions: Anorexia; Cachexia
• Intervention / Treatment: Drug: Megace F; Drug: Megace OS

• Study Type: Interventional
• Enrollment (Actual): 103
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Megace F; Megace F oral suspension	Drug: Megace F; Megace F oral suspension
Active Comparator: Megace OS; Megace acetate oral suspension	Drug: Megace OS; Megace oral suspension

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
AUC	0, 1, 2,3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120 hrs

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Boryung Pharmaceutical Co., Ltd
• Investigators: Study Chair: Kyung-sang Yu, Dr., Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (Actual): September 1, 2011
• Study Completion (Actual): January 1, 2012

Study Registration Dates

• First Submitted: July 15, 2011
• First Submitted That Met QC Criteria: July 18, 2011
• First Posted (Estimate): July 19, 2011

Study Record Updates

• Last Update Posted (Estimate): July 2, 2012
• Last Update Submitted That Met QC Criteria: June 29, 2012
• Last Verified: June 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Body Weight; Body Weight Changes; Emaciation; Weight Loss; Anorexia; Cachexia; Physiological Effects of Drugs; Antineoplastic Agents; Antineoplastic Agents, Hormonal; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptives, Oral; Contraceptive Agents, Female; Contraceptives, Oral, Synthetic; Contraceptives, Oral, Hormonal; Central Nervous System Stimulants; Appetite Stimulants; Megestrol; Megestrol Acetate
• Other Study ID Numbers: MGF-BR-CT-101