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Completed

NCT Number: NCT01589562

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

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.

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Key information

Conditions

Healthy

Age range

20 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Asan Medical Center

Seoul, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Megace 800mg/20ml

Drug

Megestrol acetate 800mg/20ml, Suspension, Single dose

Other names: Megestrol, Megestrol Acetate

DW-ES(B) 625mg/5ml

Drug

Megestrol acetate 625mg/5ml, Nano suspension, Single dose

Other names: Megestrol, Megestrol Acetate

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

Daewon Pharmaceutical Co., Ltd.

Industry

Collaborators

  • Asan Medical Center

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
May 2, 2012
Registry last updated
Jan 23, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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