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

Boryung

Status and phase: Completed; Phase 1

Conditions: Anorexia; Cachexia

Treatments: Drug: Megace OS; Drug: Megace F

Study type: Interventional

Funder types: Industry

Identifiers

NCT01397214

MGF-BR-CT-101

Details and patient eligibility

About

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

Enrollment: 103 patients

Sex: Male

Ages: 20 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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103 participants in 2 patient groups

Megace F

Experimental group

Description:

Megace F oral suspension

Treatment:

Drug: Megace F

Megace OS

Active Comparator group

Description:

Megace acetate oral suspension

Treatment:

Drug: Megace OS