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

Information source: Boryung Pharmaceutical Co., Ltd
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Cachexia; Anorexia

Intervention: Megace F (Drug); Megace OS (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Boryung Pharmaceutical Co., Ltd

Official(s) and/or principal investigator(s):
Kyung-sang Yu, Dr., Study Chair, Affiliation: Seoul National University Hospital

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

Clinical Details

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

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

Primary outcome: AUC

Secondary outcome:

Tmax

t1/2

Eligibility

Minimum age: 20 Years. Maximum age: 55 Years. Gender(s): Male.

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

Locations and Contacts

Seoul National University Hospital, Seoul, Korea, Republic of
Additional Information

Starting date: July 2011
Last updated: June 29, 2012

Page last updated: August 23, 2015

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