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

Primary Purpose

Cachexia, Anorexia

Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Megace F
Megace OS
Sponsored by
Boryung Pharmaceutical Co., Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cachexia

Eligibility Criteria

20 Years - 55 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Megace F

Megace OS

Arm Description

Megace F oral suspension

Megace acetate oral suspension

Outcomes

Primary Outcome Measures

AUC

Secondary Outcome Measures

Tmax
t1/2

Full Information

First Posted
July 15, 2011
Last Updated
June 29, 2012
Sponsor
Boryung Pharmaceutical Co., Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT01397214
Brief Title
Pharmacokinetics of Megace F and Megace OS Under Fasting and Fed Conditions in Healthy Male Volunteers
Acronym
MGF
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boryung Pharmaceutical Co., Ltd

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cachexia, Anorexia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
103 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Megace F
Arm Type
Experimental
Arm Description
Megace F oral suspension
Arm Title
Megace OS
Arm Type
Active Comparator
Arm Description
Megace acetate oral suspension
Intervention Type
Drug
Intervention Name(s)
Megace F
Intervention Description
Megace F oral suspension
Intervention Type
Drug
Intervention Name(s)
Megace OS
Intervention Description
Megace oral suspension
Primary Outcome Measure Information:
Title
AUC
Time Frame
0, 1, 2,3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120 hrs
Secondary Outcome Measure Information:
Title
Tmax
Time Frame
0, 1, 2,3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120 hrs
Title
t1/2
Time Frame
0, 1, 2,3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120 hrs

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kyung-sang Yu, Dr.
Organizational Affiliation
Seoul National University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

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

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