Phase 1 Study of DW-0919 & DW-0920 in Healthy Male Volunteers Under Fasting 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

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2012-06-30

Brief Summary

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The purpose of this study is to evaluate safety and pharmacokinetics of DW-0919 and DW-0920 in healthy male volunteers under fasting condition.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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DW-0919

Group Type ACTIVE_COMPARATOR

DW-0919

Intervention Type DRUG

Dosage form: Extended release tablet Dosage: 1 tablet

DW-0920

Group Type EXPERIMENTAL

DW-0920

Intervention Type DRUG

Dosage form: Extended release tablet Dosage: 2 tablets

Interventions

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DW-0920

Dosage form: Extended release tablet Dosage: 2 tablets

Intervention Type DRUG

DW-0919

Dosage form: Extended release tablet Dosage: 1 tablet

Intervention Type DRUG

Other Intervention Names

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Acetaminophen: 325mg Tramadol: 37.5mg Wontran ER tab. Acetaminophen: 650mg Tramadol: 75mg

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 of Hyperreactivity with drug ingredients(acetaminophen, tramadol) or opioids.
* 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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes