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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:
Information provided by (Responsible Party):
Boryung Pharmaceutical Co., Ltd
ClinicalTrials.gov Identifier:
NCT01397214
First received: July 15, 2011
Last updated: June 29, 2012
Last verified: June 2012
History of Changes

July 15, 2011
June 29, 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 ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]
  • t1/2 [ Time Frame: 0, 1, 2,3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120 hrs ] [ Designated as safety issue: Yes ]
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
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Cachexia
  • Anorexia
  • Drug: Megace F
    Megace F oral suspension
    Other Name: Megace F
  • Drug: Megace OS
    Megace oral suspension
    Other Name: Megace OS
  • 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
Male
20 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01397214
MGF-BR-CT-101
No
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