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OpenTrials
Completed

NCT Number: NCT01397214

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

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Key information

Conditions

Cachexia Anorexia Body Weight Body Weight Changes Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Thinness Weight Loss

Age range

20 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Seoul National University Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Megace F

Drug

Megace F oral suspension

Megace OS

Drug

Megace oral suspension

Primary outcomes

  1. AUC

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

Secondary outcomes

  1. Tmax

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

  2. t1/2

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

Sponsors and collaborators

Lead sponsor

Boryung Pharmaceutical Co., Ltd

Industry

Registry information

Official study 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

Acronym: MGF

Important dates

Study start
2011
Primary completion
2011
Study completion
2012
First posted
Jul 19, 2011
Registry last updated
Jul 2, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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