A Clinical Trial to Evaluate Pharmacokinetics of Daewon DW-ES(A) 625mg/5ml, Daewon DW-ES(B) 625mg/5ml and Megace 800mg/20ml in Healthy Male Volunteers Under Fed Condition

Asan Medical Center

Status and phase

Unknown

Phase 1

Conditions

Healthy Volunteers

Treatments

Drug: DW-ES(A)

Drug: DW-ES(B)

Drug: megace

Study type

Interventional

Funder types

Other

Identifiers

NCT01383330

DW-ES 1101

Details and patient eligibility

About

The purpose of this study is to evaluate pharmacokinetics of Daewon DW-ES(A) 625mg/5ml, Daewon DW-ES(B) 625mg/5ml and Megace 800mg/20ml in healthy male volunteers under fed condition.

Enrollment

15 estimated patients

Sex

Male

Ages

20 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Adult males aged 20 to 55 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 known hypersensitivity to drugs including valsartan and pitavastatin.