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
1 other identifier
interventional
103
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jul 2011
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2011
CompletedFirst Submitted
Initial submission to the registry
July 15, 2011
CompletedFirst Posted
Study publicly available on registry
July 19, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2012
CompletedJuly 2, 2012
June 1, 2012
2 months
July 15, 2011
June 29, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
AUC
0, 1, 2,3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120 hrs
Secondary Outcomes (2)
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
Study Arms (2)
Megace F
EXPERIMENTALMegace F oral suspension
Megace OS
ACTIVE COMPARATORMegace acetate oral suspension
Interventions
Eligibility Criteria
You may qualify if:
- age: 20-55 years body weight: greater than 50kg written informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul National University Hospital
Seoul, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Kyung-sang Yu, Dr.
Seoul National University Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 15, 2011
First Posted
July 19, 2011
Study Start
July 1, 2011
Primary Completion
September 1, 2011
Study Completion
January 1, 2012
Last Updated
July 2, 2012
Record last verified: 2012-06