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

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.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01775566

Enrollment

Registered

2013-01-25

Start date

2013-03-31

Completion date

2013-06-30

Last updated

2013-12-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Low Back Pain

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)

Interventions

None listed

Study design

Observational model

CASE_CROSSOVER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

MALE

Age

20 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Auclast, Cmax	Eperisone SR 0-24h, Myonal 0-24hr

Secondary

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

Countries

South Korea

Outcome results