NCT01638286

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2012

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 9, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 11, 2012

Completed
21 days until next milestone

Study Start

First participant enrolled

August 1, 2012

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
Last Updated

March 11, 2014

Status Verified

March 1, 2014

Enrollment Period

2 months

First QC Date

July 9, 2012

Last Update Submit

March 8, 2014

Conditions

Acute Low Back Pain

Study Arms (3)

Eperisone

Aceclofenac

Eperisone hydrochloride, Aceclofenac

Eligibility Criteria

Age20 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Acute low back pain

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 9, 2012

First Posted

July 11, 2012

Study Start

August 1, 2012

Primary Completion

October 1, 2012

Study Completion

April 1, 2013

Last Updated

March 11, 2014

Record last verified: 2014-03