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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01397214

Acronym

MGF

Enrollment

103

Registered

2011-07-19

Start date

2011-07-31

Completion date

2012-01-31

Last updated

2012-07-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anorexia, Cachexia

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

Interventions

DRUGMegace F

Megace F oral suspension

DRUGMegace OS

Megace oral suspension

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

20 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
AUC	0, 1, 2,3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120 hrs

Secondary

Measure	Time frame
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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026