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

This study has been completed.
Sponsor:
Collaborator:
Asan Medical Center
Information provided by (Responsible Party):
Daewon Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01589562
First received: April 24, 2012
Last updated: January 21, 2013
Last verified: January 2013

April 24, 2012
January 21, 2013
April 2012
June 2012   (final data collection date for primary outcome measure)
  • AUC of Megace 800mg/20mL [ Time Frame: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96, 120 hours post-dose ] [ Designated as safety issue: No ]
  • AUC of DW-ES(B) 625mg/5mL [ Time Frame: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96, 120 hours post-dose ] [ Designated as safety issue: No ]
  • Cmax of Megace 800mg/20mL [ Time Frame: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96, 120 hours post-dose ] [ Designated as safety issue: No ]
  • Cmax of DW-ES(B) 625mg/5mL [ Time Frame: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96, 120 hours post-dose ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01589562 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Phase 1 Study of Daewon-ES(B) & Megace in Healthy Male Volunteers Under Fed Condition
A Randomized, Open Label, Single Dose, Cross-over, Phase I Trial to Investigate Safety and Pharmacokinetics of DW-ES(B) and Megace® Under Fed Conditions in Healthy Male Volunteers

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Healthy
  • Drug: Megace 800mg/20ml
    Megestrol acetate 800mg/20ml, Suspension, Single dose
    Other Names:
    • Megestrol
    • Megestrol Acetate
  • Drug: DW-ES(B) 625mg/5ml
    Megestrol acetate 625mg/5ml, Nano suspension, Single dose
    Other Names:
    • Megestrol
    • Megestrol Acetate
  • Active Comparator: Megace 800mg/20ml
    Fed condition
    Intervention: Drug: Megace 800mg/20ml
  • Experimental: DW-ES(B) 625mg/5ml
    Fed condition
    Intervention: Drug: DW-ES(B) 625mg/5ml
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
28
June 2012
June 2012   (final data collection date for primary outcome measure)

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
Male
20 Years to 40 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01589562
DW-ES 1201
Yes
Daewon Pharmaceutical Co., Ltd.
Daewon Pharmaceutical Co., Ltd.
Asan Medical Center
Not Provided
Daewon Pharmaceutical Co., Ltd.
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP