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

This study has been completed.
Information provided by (Responsible Party):
Navipharm Corporation Identifier:
First received: January 17, 2013
Last updated: December 23, 2013
Last verified: December 2013
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.

Low Back Pain

Study Type: Observational
Study Design: Observational Model: Case-Crossover
Time Perspective: Prospective
Official 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.

Further study details as provided by Navipharm Corporation:

Primary Outcome Measures:
  • Auclast, Cmax [ Time Frame: Eperisone SR 0-24h, Myonal 0-24hr ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • AUCinf, Tmax, t1/2, Css,min, Tss,max [ Time Frame: Eperisone SR 0-24hr, Myonal 0-24hr ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Enrollment: 27
Study Start Date: March 2013
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Eperisone SR tablet 75mg, Myonal 50mg
Eperisone SR tablet 75mg Myonal 50mg

Detailed Description:
Myonal: Eperisone Hydrochloride (muscle relaxant)

Ages Eligible for Study:   20 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
acute low back pain

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01775566

Korea, Republic of
Gyeonggi SMB Growth Accelerating Center
Suwon-si, Gyeonggi do, Korea, Republic of, 441-814
Sponsors and Collaborators
Navipharm Corporation
Principal Investigator: Yoon Y Ran, M.D.Ph.D Kyungpook National University
  More Information

Responsible Party: Navipharm Corporation Identifier: NCT01775566     History of Changes
Other Study ID Numbers: NVP-EPT-PK-01 
Study First Received: January 17, 2013
Last Updated: December 23, 2013
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Low Back Pain
Back Pain
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Autonomic Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Muscle Relaxants, Central
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Vasodilator Agents processed this record on May 26, 2016