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
About this trial
This is an interventional treatment trial for Cachexia
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
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
NCT ID
NCT01397214
First Posted
July 15, 2011
Last Updated
June 29, 2012
Sponsor
Boryung Pharmaceutical Co., Ltd
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
Learn more about this trial
Pharmacokinetics of Megace F and Megace OS Under Fasting and Fed Conditions in Healthy Male Volunteers
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