Study to Evaluate a Pharmacokinetic Drug Interaction Between Eperisone Hydrochloride and Aceclofenac in Healthy Male Subjects

Acute Low Back Pain Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01638286
• Other study ID #: HM-EPAC-101
• Status: Completed
• Phase: N/A
• First received: July 9, 2012
• Last updated: March 8, 2014
• Start date: August 2012
• Est. completion date: April 2013

Study information

• Verified date: March 2014
• Source: Hanmi Pharmaceutical Company Limited
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

A randomized, open label, single-dose, 6-sequence, 3-period, crossover study to evaluate a pharmacokinetic drug interaction between eperisone hydrochloride and aceclofenac in healthy male subjects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: April 2013
• Est. primary completion date: October 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 45 Years

Eligibility

Inclusion Criteria:

• BMI : 20.0 - 28.0 kg/m2 willingness to sign the written informed consent form(ICF)

Exclusion Criteria:

• Evidence of clinically relevant pathology within 30 days prior to drug administration History of relevant drug and/or food allergies

Study Design

Observational Model: Case-Crossover, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Acute Low Back Pain
• Low Back Pain

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hanmi Pharmaceutical Company Limited