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CompletedNCT01638286Updated Mar 11, 2014

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

An observational study in Acute Low Back Pain, sponsored by Hanmi Pharmaceutical Company Limited. Completed. Open to male participants aged 20 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-03-11.

Sponsored by Hanmi Pharmaceutical Company Limited · Observational

Study type
Observational
Model
Case-crossover
Time perspective
Cross-sectional
Enrollment
24
Ages
20 Years to 45 Years
Sex
Male
01

Study 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.

02

Conditions studied

  • Acute Low Back Pain

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03

In context

Low Back Pain

2,818 studies on the registry are indexed under Low Back Pain; 482 are open to participants now.

This study's enrollment of 24 is below the median of 100 across 475 observational studies indexed under Low Back Pain.

Browse Low Back Pain studies →

Lead sponsor

Hanmi Pharmaceutical Company Limited is the lead sponsor of 188 studies on the registry; 10 are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 6 (55%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 45 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Acute low back pain

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Evidence of clinically relevant pathology within 30 days prior to drug administration History of relevant drug and/or food allergies
05

Study design

Observational model
Case-crossover
Time perspective
Cross-sectional
Enrollment
24 participants (actual)

Groups and cohorts

  • Eperisone
  • Aceclofenac
  • Eperisone hydrochloride, Aceclofenac
06

Study locations

No study locations are listed for this record.

07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 11, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT01638286
Lead sponsor
Hanmi Pharmaceutical Company Limited
Responsible party
Sponsor
First posted
Jul 11, 2012
Start date
Aug 2012
Primary completion
Oct 2012
Completion
Apr 2013
Last update
Mar 11, 2014

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2014. You cannot join it, but the record below documents what was studied.

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