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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
  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
Endpoint Classification: Bio-equivalence Study
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 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 ] [ 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 ]

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

Ages Eligible for Study:   20 Years to 40 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01589562

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

No publications provided

Responsible Party: Daewon Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT01589562     History of Changes
Other Study ID Numbers: DW-ES 1201
Study First Received: April 24, 2012
Last Updated: January 21, 2013
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

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

ClinicalTrials.gov processed this record on November 25, 2014