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

Completed

• Conditions: Low Back Pain

• Registration Number: NCT01775566
• Lead Sponsor: NVP Healthcare

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.

Detailed Description

Myonal: Eperisone Hydrochloride (muscle relaxant)

Study Timeline

• Study First Submitted: 2013-01-17
• Study First Submitted QC: 2013-01-22
• Study First Posted: 2013-01-25
• Study Start: 2013-03
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Status Verified: 2013-12
• Last Update Submitted: 2013-12-23
• Last Update Posted: 2013-12-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 27

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Auclast, Cmax	Eperisone SR 0-24h, Myonal 0-24hr

Secondary Outcome Measures

Name	Time	Method
AUCinf, Tmax, t1/2, Css,min, Tss,max	Eperisone SR 0-24hr, Myonal 0-24hr

Trial Locations

Locations (1)

Gyeonggi SMB Growth Accelerating Center; 🇰🇷 Suwon-si, Gyeonggi do, Korea, Republic of