Clinical Trial to Compare the Pharmacokinetics and Safety of Eperisone HCl SR Tablet 75mg and Myonal Tablet 50mg

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

Total Enrollment

27 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-03-31

Study Completion Date

2013-06-30

Brief Summary

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The purpose of this study is to Evaluate and Compare Safety and Pharmacokinetic of the Eperisone HCl SR and Myonal in healthy Korean male adults.

Detailed Description

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Myonal: Eperisone Hydrochloride (muscle relaxant)

Conditions

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Low Back Pain

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

PROSPECTIVE

Study Groups

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Eperisone SR tablet 75mg, Myonal 50mg

Eperisone SR tablet 75mg Myonal 50mg

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Healthy male subjects age between 20 and 55 singed informed consent

Exclusion Criteria

* Hypotension or hypertension has a history of allergy reaction of this drug or other drugs

Minimum Eligible Age

20 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yoon Y Ran, M.D.Ph.D

Role: PRINCIPAL_INVESTIGATOR

Kyungpook National University Hospital

Locations

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Gyeonggi SMB Growth Accelerating Center

Suwon, Gyeonggi-do, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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NVP-EPT-PK-01

Identifier Type: -

Identifier Source: org_study_id