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

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01383330
• Other study ID #: DW-ES 1101
• Status: Not yet recruiting
• Phase: Phase 1
• First received: June 27, 2011
• Last updated: June 27, 2011
• Start date: July 2011

Study information

• Verified date: June 2011
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 15
• Est. primary completion date: September 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 55 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• megace
800mg
• DW-ES(A)
625mg
• DW-ES(B)
625mg

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Asan Medical Center