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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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Megace

800mg

Group Type EXPERIMENTAL

megace

Intervention Type DRUG

800mg

DW-ES(A)

625mg

Group Type ACTIVE_COMPARATOR

DW-ES(A)

Intervention Type DRUG

625mg

DW-ES(B)

625mg

Group Type ACTIVE_COMPARATOR

DW-ES(B)

Intervention Type DRUG

625mg

Interventions

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megace

800mg

Intervention Type DRUG

DW-ES(A)

625mg

Intervention Type DRUG

DW-ES(B)

625mg

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes