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

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ClinicalTrials.gov Identifier: NCT01456624
Recruitment Status : Completed
First Posted : October 21, 2011
Last Update Posted : June 25, 2014
Sponsor:
Information provided by (Responsible Party):
Gyu-Jeong Noh, Asan Medical Center

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.

Condition or disease Intervention/treatment Phase
Healthy Drug: Megace Drug: DW-ES(B) Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (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
Study Start Date : September 2011
Actual Primary Completion Date : June 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Megace / Fasting condition
800mg
Drug: Megace
800mg
Experimental: DW-ES(B) / Fasting condition
625mg
Drug: DW-ES(B)
625mg
Active Comparator: Megace / Fed condition
800mg
Drug: Megace
800mg
Experimental: DW-ES(B) / Fed condition
625mg
Drug: DW-ES(B)
625mg



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



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

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01456624


Locations
Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
Asan Medical Center

Additional Information:
Responsible Party: Gyu-Jeong Noh, Professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT01456624     History of Changes
Other Study ID Numbers: 2011-0686
First Posted: October 21, 2011    Key Record Dates
Last Update Posted: June 25, 2014
Last Verified: June 2014

Additional relevant MeSH terms:
Megestrol Acetate
Megestrol
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