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

Condition(s) targeted: Healthy

Intervention: Megace 800mg/20ml (Drug); DW-ES(B) 625mg/5ml (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Daewon Pharmaceutical Co., Ltd.

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.

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 design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Primary outcome:

AUC of Megace 800mg/20mL

AUC of DW-ES(B) 625mg/5mL

Cmax of Megace 800mg/20mL

Cmax of DW-ES(B) 625mg/5mL

Minimum age: 20 Years. Maximum age: 40 Years. Gender(s): Male.

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

Asan Medical Center, Seoul, Korea, Republic of

Starting date: April 2012
Last updated: January 21, 2013