Back to resultsPhase 1 Study of Daewon-ES(B) & Megace in Healthy Male Volunteers Under Fed Condition
Primary Purpose
Healthy
Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Megace 800mg/20ml
DW-ES(B) 625mg/5ml
Sponsored by
About this trial
This is an interventional supportive care trial for Healthy
Eligibility 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.
- History of taking megestrol
Sites / Locations
- Asan Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Megace 800mg/20ml
DW-ES(B) 625mg/5ml
Arm Description
Fed condition
Fed condition
Outcomes
Primary Outcome Measures
AUC of Megace 800mg/20mL
AUC of DW-ES(B) 625mg/5mL
Cmax of Megace 800mg/20mL
Cmax of DW-ES(B) 625mg/5mL
Secondary Outcome Measures
Full Information
NCT ID
NCT01589562
First Posted
April 24, 2012
Last Updated
January 21, 2013
Sponsor
Daewon Pharmaceutical Co., Ltd.
Collaborators
Asan Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01589562
Brief Title
Phase 1 Study of Daewon-ES(B) & Megace in Healthy Male Volunteers Under Fed Condition
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 Fed Conditions in Healthy Male Volunteers
Study Type
Interventional
2. Study Status
Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Daewon Pharmaceutical Co., Ltd.
Collaborators
Asan Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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 fed condition.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
28 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Megace 800mg/20ml
Arm Type
Active Comparator
Arm Description
Fed condition
Arm Title
DW-ES(B) 625mg/5ml
Arm Type
Experimental
Arm Description
Fed condition
Intervention Type
Drug
Intervention Name(s)
Megace 800mg/20ml
Other Intervention Name(s)
Megestrol, Megestrol Acetate
Intervention Description
Megestrol acetate 800mg/20ml, Suspension, Single dose
Intervention Type
Drug
Intervention Name(s)
DW-ES(B) 625mg/5ml
Other Intervention Name(s)
Megestrol, Megestrol Acetate
Intervention Description
Megestrol acetate 625mg/5ml, Nano suspension, Single dose
Primary Outcome Measure Information:
Title
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
Title
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
Title
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
Title
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
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
History of taking megestrol
Facility Information:
Facility Name
Asan Medical Center
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Phase 1 Study of Daewon-ES(B) & Megace in Healthy Male Volunteers Under Fed Condition
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