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Phase 1 Study of Daewon-ES(B) & Megace in Healthy Male Volunteers Under Fed Condition

NCT01589562 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2013-01-23

No results posted yet for this study

Summary

The purpose of this study is to evaluate pharmacokinetics of Daewon DW-ES(B) 625mg/5ml and Megace 800mg/20ml in healthy male volunteers under fed condition.

Conditions

  • Healthy

Interventions

DRUG

Megace 800mg/20ml

Megestrol acetate 800mg/20ml, Suspension, Single dose

DRUG

DW-ES(B) 625mg/5ml

Megestrol acetate 625mg/5ml, Nano suspension, Single dose

Sponsors & Collaborators

  • Asan Medical Center

    collaborator OTHER

  • Daewon Pharmaceutical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Max Age
40 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-04-30
Primary Completion
2012-06-30
Completion
2012-06-30

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01589562 on ClinicalTrials.gov