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

Completed

• Conditions: Acute Low Back Pain

• Registration Number: NCT01638286
• Lead Sponsor: Hanmi Pharmaceutical Company Limited

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-07-09
• Study First Submitted QC: 2012-07-10
• Study First Posted: 2012-07-11
• Study Start: 2012-08
• Primary Completion: 2012-10
• Study Completion: 2013-04
• Status Verified: 2014-03
• Last Update Submitted: 2014-03-08
• Last Update Posted: 2014-03-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 24

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified