CompletedInterventionalPhase 2Updated Aug 23, 2013
Study to Evaluate a Pharmacokinetic Drug Interaction Between Eperisone Hydrochloride and Aceclofenac in Healthy Male Subjects | NCT01638286 | Trialant
CompletedObservationalUpdated Mar 11, 2014
Study to Evaluate a Pharmacokinetic Drug Interaction Between Eperisone Hydrochloride and Aceclofenac in Healthy Male Subjects
ClinicalTrials.gov ID
NCT01638286
Lead Sponsor
Hanmi Pharmaceutical Company LimitedINDUSTRY
Overall Status
Completed
Study Type
Observational
Enrollment
24Actual
Last Update Posted
Mar 11, 2014Estimated
Start Date
Aug 2012
Primary Completion Date
Oct 2012Actual
Completion Date
Apr 2013Actual
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.
Acute Low Back Pain
No interventions
There are no interventions for this study.
Ages Eligible for Study
Adult (18-64)
Sexes Eligible for Study
Male
Accepts Healthy Volunteers
Yes
Eligibility Criteria
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