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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01397214
First Posted: July 19, 2011
Last Update Posted: July 2, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Boryung Pharmaceutical Co., Ltd
July 15, 2011
July 19, 2011
July 2, 2012
July 2011
September 2011   (Final data collection date for primary outcome measure)
AUC [ Time Frame: 0, 1, 2,3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120 hrs ]
Same as current
Complete list of historical versions of study NCT01397214 on ClinicalTrials.gov Archive Site
  • Tmax [ Time Frame: 0, 1, 2,3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120 hrs ]
  • t1/2 [ Time Frame: 0, 1, 2,3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120 hrs ]
Same as current
Not Provided
Not Provided
 
Pharmacokinetics of Megace F and Megace OS Under Fasting and Fed Conditions in Healthy Male Volunteers
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

Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Cachexia
  • Anorexia
  • Drug: Megace F
    Megace F oral suspension
  • Drug: Megace OS
    Megace oral suspension
  • Experimental: Megace F
    Megace F oral suspension
    Intervention: Drug: Megace F
  • Active Comparator: Megace OS
    Megace acetate oral suspension
    Intervention: Drug: Megace OS
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
103
January 2012
September 2011   (Final data collection date for primary outcome measure)

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

Sexes Eligible for Study: Male
20 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
 
NCT01397214
MGF-BR-CT-101
No
Not Provided
Not Provided
Boryung Pharmaceutical Co., Ltd
Boryung Pharmaceutical Co., Ltd
Not Provided
Study Chair: Kyung-sang Yu, Dr. Seoul National University Hospital
Boryung Pharmaceutical Co., Ltd
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP