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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Navipharm Corporation
ClinicalTrials.gov Identifier:
NCT01775566
First received: January 17, 2013
Last updated: December 23, 2013
Last verified: December 2013
  Purpose

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.


Condition
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.

Resource links provided by NLM:


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

plasma


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)
Groups/Cohorts
Eperisone SR tablet 75mg, Myonal 50mg
Eperisone SR tablet 75mg Myonal 50mg

Detailed Description:

Myonal: Eperisone Hydrochloride (muscle relaxant)

  Eligibility

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

Criteria

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 ClinicalTrials.gov identifier: NCT01775566

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

No publications provided

Responsible Party: Navipharm Corporation
ClinicalTrials.gov 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:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Eperisone
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Muscle Relaxants, Central
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Parasympatholytics
Autonomic Agents
Vasodilator Agents
Anticonvulsants

ClinicalTrials.gov processed this record on July 24, 2014