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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:
ClinicalTrials.gov Identifier:
NCT01589562
First Posted: May 2, 2012
Last Update Posted: January 23, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Asan Medical Center
Information provided by (Responsible Party):
Daewon Pharmaceutical Co., Ltd.
  Purpose
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.

Condition Intervention Phase
Healthy Drug: Megace 800mg/20ml Drug: DW-ES(B) 625mg/5ml Phase 1

Study Type: Interventional
Study Design: 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 Fed Conditions in Healthy Male Volunteers

Resource links provided by NLM:


Further study details as provided by Daewon Pharmaceutical Co., Ltd.:

Primary Outcome Measures:
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]

Estimated Enrollment: 28
Study Start Date: April 2012
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Megace 800mg/20ml
Fed condition
Drug: Megace 800mg/20ml
Megestrol acetate 800mg/20ml, Suspension, Single dose
Other Names:
  • Megestrol
  • Megestrol Acetate
Experimental: DW-ES(B) 625mg/5ml
Fed condition
Drug: DW-ES(B) 625mg/5ml
Megestrol acetate 625mg/5ml, Nano suspension, Single dose
Other Names:
  • Megestrol
  • Megestrol Acetate

  Eligibility

Information from the National Library of Medicine

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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.
  • History of taking megestrol
  Contacts and Locations
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): NCT01589562


Locations
Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
Daewon Pharmaceutical Co., Ltd.
Asan Medical Center
  More Information

Responsible Party: Daewon Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT01589562     History of Changes
Other Study ID Numbers: DW-ES 1201
First Submitted: April 24, 2012
First Posted: May 2, 2012
Last Update Posted: January 23, 2013
Last Verified: January 2013

Additional relevant MeSH terms:
Megestrol
Megestrol Acetate
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Appetite Stimulants
Central Nervous System Stimulants