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

Hanmi Pharmaceutical

Status: Completed

Conditions: Acute Low Back Pain

Study type: Observational

Funder types: Industry

Identifiers

NCT01638286

HM-EPAC-101

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: Male

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

24 participants in 3 patient groups

Eperisone

Aceclofenac

Eperisone hydrochloride, Aceclofenac