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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
  Purpose

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


Condition Intervention Phase
Cachexia
Anorexia
 Drug: Megace F
Drug: Megace OS
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Boryung Pharmaceutical Co., Ltd:

Primary Outcome Measures:
  • AUC [ Time Frame: 0, 1, 2,3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120 hrs ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 103
Study Start Date: July 2011
Study Completion Date: January 2012
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Megace F
Megace F oral suspension
 Drug: Megace F
Megace F oral suspension
Other Name: Megace F
Active Comparator: Megace OS
Megace acetate oral suspension
 Drug: Megace OS
Megace oral suspension
Other Name: Megace OS

  Eligibility

Ages Eligible for Study:   20 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01397214

Locations
Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Boryung Pharmaceutical Co., Ltd
Investigators
Study Chair: Kyung-sang Yu, Dr. Seoul National University Hospital
  More Information

No publications provided

Responsible Party: Boryung Pharmaceutical Co., Ltd
ClinicalTrials.gov Identifier: NCT01397214     History of Changes
Other Study ID Numbers: MGF-BR-CT-101
Study First Received: July 15, 2011
Last Updated: June 29, 2012
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Anorexia
Cachexia
Signs and Symptoms, Digestive
Signs and Symptoms
Emaciation
Weight Loss
Body Weight Changes
Body Weight
Megestrol
Megestrol Acetate
Antineoplastic Agents, Hormonal
Antineoplastic Agents
 Therapeutic Uses
Pharmacologic Actions
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Appetite Stimulants
Central Nervous System Stimulants
Central Nervous System Agents

ClinicalTrials.gov processed this record on June 18, 2013