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
-
-
Gyeonggi do
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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
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.