Phase 1 Study of Daewon-ES(B) & Megace in Healthy Male Volunteers Under Fed Condition
A Randomized, Open Label, Single Dose, Cross-over, Phase I Trial to Investigate Safety and Pharmacokinetics of DW-ES(B) and Megace® Under Fed Conditions in Healthy Male Volunteers
1 other identifier
interventional
28
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 healthy
Started Apr 2012
Shorter than P25 for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2012
CompletedFirst Submitted
Initial submission to the registry
April 24, 2012
CompletedFirst Posted
Study publicly available on registry
May 2, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2012
CompletedJanuary 23, 2013
January 1, 2013
2 months
April 24, 2012
January 21, 2013
Conditions
Outcome Measures
Primary Outcomes (4)
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
Study Arms (2)
Megace 800mg/20ml
ACTIVE COMPARATORFed condition
DW-ES(B) 625mg/5ml
EXPERIMENTALFed condition
Interventions
Megestrol acetate 800mg/20ml, Suspension, Single dose
Megestrol acetate 625mg/5ml, Nano suspension, Single dose
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Daewon Pharmaceutical Co., Ltd.lead
- Asan Medical Centercollaborator
Study Sites (1)
Asan Medical Center
Seoul, South Korea
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 24, 2012
First Posted
May 2, 2012
Study Start
April 1, 2012
Primary Completion
June 1, 2012
Study Completion
June 1, 2012
Last Updated
January 23, 2013
Record last verified: 2013-01