NCT01775566

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2013

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 17, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 25, 2013

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2013

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

December 25, 2013

Status Verified

December 1, 2013

Enrollment Period

3 months

First QC Date

January 17, 2013

Last Update Submit

December 23, 2013

Conditions

Low Back Pain

Outcome Measures

Primary Outcomes (1)

  • Auclast, Cmax

    Eperisone SR 0-24h, Myonal 0-24hr

Secondary Outcomes (1)

  • AUCinf, Tmax, t1/2, Css,min, Tss,max

    Eperisone SR 0-24hr, Myonal 0-24hr

Study Arms (1)

Eperisone SR tablet 75mg, Myonal 50mg

Eperisone SR tablet 75mg Myonal 50mg

Eligibility Criteria

Age20 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

acute low back pain

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gyeonggi SMB Growth Accelerating Center

Suwon, Gyeonggi-do, 441-814, South Korea

Location

Biospecimen

Retention: SAMPLES WITH DNA

plasma

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Yoon Y Ran, M.D.Ph.D

    Kyungpook National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 17, 2013

First Posted

January 25, 2013

Study Start

March 1, 2013

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

December 25, 2013

Record last verified: 2013-12

Locations

KR(1)