Phase 1 Study of Daewon-ES(B) & Megace in Healthy Male Volunteers Under Fasting and Fed Condition
NCT ID: NCT01456624
Last Updated: 2014-06-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
56 participants
INTERVENTIONAL
2011-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
SUPPORTIVE_CARE
NONE
Study Groups
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Megace / Fasting condition
800mg
Megace
800mg
DW-ES(B) / Fasting condition
625mg
DW-ES(B)
625mg
Megace / Fed condition
800mg
Megace
800mg
DW-ES(B) / Fed condition
625mg
DW-ES(B)
625mg
Interventions
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Megace
800mg
DW-ES(B)
625mg
Eligibility Criteria
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Inclusion Criteria
* 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 of gastrointestinal disorders (bleeding, ulceration, hemorrhoids, piles) or disorders of absorption, distribution, metabolism, excretion.
20 Years
40 Years
MALE
Yes
Sponsors
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Asan Medical Center
OTHER
Responsible Party
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Gyu-Jeong Noh
Professor
Locations
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Asan Medical Center
Seoul, , South Korea
Countries
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Related Links
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Clinical Research Center, Asan Medical Center
Other Identifiers
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2011-0686
Identifier Type: -
Identifier Source: org_study_id
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