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

Asan Medical Center

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: DW-ES(B); Drug: Megace

Study type: Interventional

Funder types: Other

Identifiers

NCT01456624

2011-0686

Details and patient eligibility

About

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 fasting and fed condition.

Enrollment: 56 patients

Sex: Male

Ages: 20 to 40 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

56 participants in 4 patient groups

Megace / Fasting condition

Active Comparator group

Description:

800mg

Treatment:

Drug: Megace

DW-ES(B) / Fasting condition

Experimental group

Description:

625mg

Treatment:

Drug: DW-ES(B)

Megace / Fed condition

Active Comparator group

Description:

800mg

Treatment:

Drug: Megace

DW-ES(B) / Fed condition

Experimental group

Description:

625mg

Treatment:

Drug: DW-ES(B)