Phase 1 Study of Daewon-ES(B) & Megace in Healthy Male Volunteers Under Fed Condition
NCT ID: NCT01589562
Last Updated: 2013-01-23
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
28 participants
INTERVENTIONAL
2012-04-30
2012-06-30
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 800mg/20ml
Fed condition
Megace 800mg/20ml
Megestrol acetate 800mg/20ml, Suspension, Single dose
DW-ES(B) 625mg/5ml
Fed condition
DW-ES(B) 625mg/5ml
Megestrol acetate 625mg/5ml, Nano suspension, Single dose
Interventions
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Megace 800mg/20ml
Megestrol acetate 800mg/20ml, Suspension, Single dose
DW-ES(B) 625mg/5ml
Megestrol acetate 625mg/5ml, Nano suspension, Single dose
Other Intervention Names
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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.
* History of taking megestrol
20 Years
40 Years
MALE
Yes
Sponsors
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Asan Medical Center
OTHER
Daewon Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Asan Medical Center
Seoul, , South Korea
Countries
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Other Identifiers
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DW-ES 1201
Identifier Type: -
Identifier Source: org_study_id
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