Phase 1 Study of Daewon-ES(B) & Megace in Healthy Male Volunteers Under Fed Condition
Status and phase
Completed
Phase 1
Conditions
Healthy
Treatments
Drug: Megace 800mg/20ml
Drug: DW-ES(B) 625mg/5ml
Details and patient eligibility
About
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.
Enrollment
28 estimated patients
Sex
Male
Ages
20 to 40 years old
Volunteers
Accepts Healthy Volunteers
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
Trial design
Primary purpose
Supportive Care
Allocation
Randomized
Interventional model
Crossover Assignment
Masking
None (Open label)
28 participants in 2 patient groups
Megace 800mg/20ml
Active Comparator group
Description:
Fed condition
Treatment:
Drug: Megace 800mg/20ml
DW-ES(B) 625mg/5ml
Experimental group
Description:
Fed condition
Treatment:
Drug: DW-ES(B) 625mg/5ml
Trial contacts and locations
1
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Data sourced from clinicaltrials.gov
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