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

Cachexia Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01397214
• Other study ID #: MGF-BR-CT-101
• Status: Completed
• Phase: Phase 1
• First received: July 15, 2011
• Last updated: June 29, 2012
• Start date: July 2011
• Est. completion date: January 2012

Study information

• Verified date: June 2012
• Source: Boryung Pharmaceutical Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: January 2012
• Est. primary completion date: September 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 55 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Anorexia
• Cachexia

Intervention

Drug:
• Megace F
Megace F oral suspension
• Megace OS
Megace oral suspension

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Boryung Pharmaceutical Co., Ltd

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUC		0, 1, 2,3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120 hrs	Yes
Secondary	Tmax		0, 1, 2,3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120 hrs	Yes
Secondary	t1/2		0, 1, 2,3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120 hrs	Yes