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Phase 1 Study of Daewon-ES(B) & Megace in Healthy Male Volunteers Under Fasting and Fed Condition

This study has been completed.
Information provided by (Responsible Party):
Gyu-Jeong Noh, Asan Medical Center Identifier:
First received: October 19, 2011
Last updated: June 23, 2014
Last verified: June 2014
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.

Condition Intervention Phase
Drug: Megace
Drug: DW-ES(B)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: A Randomized, Open Label, Single Dose, Cross-over, Phase I Trial to Investigate Safety and Pharmacokinetics of DW-ES(B) and Megace® Under Fasting and Fed Conditions in Healthy Male Volunteers

Resource links provided by NLM:

Further study details as provided by Asan Medical Center:

Primary Outcome Measures:
  • Safety (normal results for safety tests) [ Time Frame: 30days ]
    Adverse events Physical examination, vital signs

Enrollment: 56
Study Start Date: September 2011
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Megace / Fasting condition
Drug: Megace
Experimental: DW-ES(B) / Fasting condition
Drug: DW-ES(B)
Active Comparator: Megace / Fed condition
Drug: Megace
Experimental: DW-ES(B) / Fed condition
Drug: DW-ES(B)


Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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.
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Please refer to this study by its identifier: NCT01456624

Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
Asan Medical Center
  More Information

Additional Information:
Responsible Party: Gyu-Jeong Noh, Professor, Asan Medical Center Identifier: NCT01456624     History of Changes
Other Study ID Numbers: 2011-0686
Study First Received: October 19, 2011
Last Updated: June 23, 2014

Additional relevant MeSH terms:
Megestrol Acetate
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Appetite Stimulants
Central Nervous System Stimulants
Physiological Effects of Drugs
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents processed this record on April 25, 2017