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

December 23, 2013 updated by: NVP Healthcare

A Phase I Clinical Trial to Compare the Pharmacokinetics and Safety of Eperisone HCl SR Tablet 75mg and Myonal Tablet 50mgafter Oral Administration in Healthy Male Subjects.

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.

Study Overview

Status

Completed

Conditions

Detailed Description

Myonal: Eperisone Hydrochloride (muscle relaxant)

Study Type

Observational

Enrollment (Actual)

27

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Gyeonggi do
      • Suwon-si, Gyeonggi do, Korea, Republic of, 441-814
        • Gyeonggi SMB Growth Accelerating Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 51 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Probability Sample

Study Population

acute low back pain

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Crossover
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Eperisone SR tablet 75mg, Myonal 50mg
Eperisone SR tablet 75mg Myonal 50mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Auclast, Cmax
Time Frame: Eperisone SR 0-24h, Myonal 0-24hr
Eperisone SR 0-24h, Myonal 0-24hr

Secondary Outcome Measures

Outcome Measure
Time Frame
AUCinf, Tmax, t1/2, Css,min, Tss,max
Time Frame: Eperisone SR 0-24hr, Myonal 0-24hr
Eperisone SR 0-24hr, Myonal 0-24hr

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NVP Healthcare

Investigators

  • Principal Investigator: Yoon Y Ran, M.D.Ph.D, Kyungpook National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

January 17, 2013

First Submitted That Met QC Criteria

January 22, 2013

First Posted (Estimate)

January 25, 2013

Study Record Updates

Last Update Posted (Estimate)

December 25, 2013

Last Update Submitted That Met QC Criteria

December 23, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NVP-EPT-PK-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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