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

March 8, 2014 updated by: Hanmi Pharmaceutical Company Limited
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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

24

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Sampling Method

Probability Sample

Study Population

Acute low back pain

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Eperisone
Aceclofenac
Eperisone hydrochloride, Aceclofenac

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hanmi Pharmaceutical Company Limited

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (Actual)

October 1, 2012

Study Completion (Actual)

April 1, 2013

Study Registration Dates

First Submitted

July 9, 2012

First Submitted That Met QC Criteria

July 10, 2012

First Posted (Estimate)

July 11, 2012

Study Record Updates

Last Update Posted (Estimate)

March 11, 2014

Last Update Submitted That Met QC Criteria

March 8, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HM-EPAC-101

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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