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

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.

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Key information

Conditions

Low Back Pain Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–55 year

Sex eligibility

Male

Study type

Observational

Primary location

Gyeonggi SMB Growth Accelerating Center

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

About this study

Myonal: Eperisone Hydrochloride (muscle relaxant)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Auclast, Cmax

Time frame: Eperisone SR 0-24h, Myonal 0-24hr

Secondary outcomes

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

Time frame: Eperisone SR 0-24hr, Myonal 0-24hr

Sponsors and collaborators

Lead sponsor

NVP Healthcare

Industry

Registry information

Official study title

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.

Important dates

Study start: 2013
Primary completion: 2013
Study completion: 2013
First posted: Jan 25, 2013
Registry last updated: Dec 25, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed