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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Megace 800mg/20ml; Drug: DW-ES(B) 625mg/5ml

• Registration Number: NCT01589562
• Lead Sponsor: Daewon Pharmaceutical Co., Ltd.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04
• Study First Submitted: 2012-04-24
• Study First Submitted QC: 2012-04-30
• Study First Posted: 2012-05-02
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-21
• Last Update Posted: 2013-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 28

Inclusion Criteria

• Adult males aged 20 to 40 years at screening.
• No significant congenital/chronic disease. No symptoms in physical examination.
• Appropriate subjects as determined by past medical history, laboratory tests, serology and urinalysis.
• Be able to understand the objective, method of the study, the characteristics of investigational drug, and comply with the requirement of the study. Subject must provide written informed consent prior to study participation

Exclusion Criteria

• History or presence of liver, kidney, or nervous system disease, respiratory disorders, endocrinological disorders, hemato-oncologic, cardiovascular or psychiatric or cognitive disorders.
• History of gastrointestinal disorders (bleeding, ulceration, hemorrhoids, piles) or disorders of absorption, distribution, metabolism, excretion.
• History of taking megestrol

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Megace 800mg/20ml	Megace 800mg/20ml	Fed condition
DW-ES(B) 625mg/5ml	DW-ES(B) 625mg/5ml	Fed condition

Primary Outcome Measures

Name	Time	Method
AUC of Megace 800mg/20mL	0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96, 120 hours post-dose
AUC of DW-ES(B) 625mg/5mL	0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96, 120 hours post-dose
Cmax of Megace 800mg/20mL	0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96, 120 hours post-dose
Cmax of DW-ES(B) 625mg/5mL	0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96, 120 hours post-dose

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of