Status:
COMPLETED
Phase 1 Study of Daewon-ES(B) & Megace in Healthy Male Volunteers Under Fasting and Fed Condition
Lead Sponsor:
Asan Medical Center
Conditions:
Healthy
Eligibility:
MALE
20-40 years
Phase:
PHASE1
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 fasting and fed condition.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT01456624
Start Date
September 1 2011
Last Update
June 25 2014
Active Locations (1)
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1
Asan Medical Center
Seoul, South Korea