Low Back PainPhase 1eperisoneNCT01885520

Clinical Trial to Evaluate the Food Effect on the Pharmacokinetics of Eperisone HCl SR Tablet 75mg

A Phase 1 study testing fasting condition and fed condition in people with Low Back Pain, run by NVP Healthcare at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to evaluate the food effect on the pharmacokinetics of eperisone HCl SR tablet Read more about this study

Who is it for?: Ages 20 to 55 years, men onlyHealthy volunteers can take part
Conditions the study is for: Low Back Pain
What is being tested?: fasting condition and fed condition
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 28 participants
Where: 1 siteSouth Korea
Study dates: Jul 2013to Jul 2013
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 to 55 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

Healthy male subjects age between 20 and 55 signed informed consent

Who cannot join

Hypotension or hypertension has a history of allergy reaction of this drug or other drugs

Trial locations and contacts

1 site in 1 country.

South Korea1 site

Kyungpook National University Hospital
Jung-gu, Daegu, 700-721

Other trials in South Korea

About this study

Official title: A Randomized,Open-label, Single-dose, Crossover Clinical Trial to Evaluate the Food Effect on the Pharmacokinetics of Eperisone HCl SR Tablet 75mg After Oral Administration in Healthy Adult Male Subjects.

The purpose of this study is to evaluate the food effect on the pharmacokinetics of eperisone HCl SR tablet

Read the detailed description

eperisone hydrochloride(muscle relaxant)

Conditions: Low Back Pain
Being tested: fasting condition, fed condition
Keywords: low back pain
Medical subject headings: Low Back Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

fasting conditionDietary supplement
eperisone SR tablet 75mg administrated under fasting
fed conditionDietary supplement
eperisone SR tablet 75mg administrated fed condition

Study groups in NCT01885520
Study group	Role	What they receive
fasting condition	Experimental	eperisone SR administrated under fasting condition Receives: Dietary Supplement: fasting condition
Fed condition	Active comparator	eperisone SR administrated under fed condition Receives: Dietary Supplement: fed condition

What is being measured

The primary outcome is the main question the study is designed to answer.

AUC
Measured: 0-24h
Cmax
Measured: 0-24h

Secondary outcomes (2)

T1/2
Measured: 0-24h
Tmax
Measured: 0-24h

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2013Jul 2013

First posted25 Jun 2013 (estimated)
Study startJul 2013
Primary completionJul 2013
Study completionJul 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Low Back PainStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 28 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01885520
Sponsor's protocol ID: NVP-EPT-PK-02
Acronym: eperisone
Status last verified: Mar 2016
First submitted: 15 Jun 2013
Last updated: 25 Mar 2016
Results posted: No
Data monitoring committee: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
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Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
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Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific Low Back Pain
Nonspecific Low Back Pain
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)

All Low Back Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized,Open-label, Single-dose, Crossover Clinical Trial to Evaluate the Food Effect on the Pharmacokinetics of Eperisone HCl SR Tablet 75mg After Oral Administration in Healthy Adult Male Subjects.
ClinicalTrials.gov ID: NCT01885520
Acronym / sponsor ID: eperisone / NVP-EPT-PK-02
Conditions: Low Back Pain
Keywords: low back pain
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 28 participants (actual)
Lead sponsor: NVP HealthcareIndustry (pharma, biotech, devices)
Study start: Jul 2013
Primary completion: Jul 2013 (actual)
Study completion: Jul 2013 (actual)
First posted: 25 Jun 2013 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to evaluate the food effect on the pharmacokinetics of eperisone HCl SR tablet

Detailed description

eperisone hydrochloride(muscle relaxant)

Study design

Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
fasting condition	Experimental	Dietary Supplement: fasting conditioneperisone SR administrated under fasting condition
Fed condition	Active comparator	Dietary Supplement: fed conditioneperisone SR administrated under fed condition

Who may qualify

Ages: 20 to 55 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (1 listed)

Healthy male subjects age between 20 and 55 signed informed consent

Key exclusion criteria (1 listed)

Hypotension or hypertension has a history of allergy reaction of this drug or other drugs

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
fasting conditioneperisone SR tablet 75mg administrated under fasting	Dietary supplement	fasting condition
fed conditioneperisone SR tablet 75mg administrated fed condition	Dietary supplement	Fed condition

Primary outcome

AUC
Time frame: 0-24h
Cmax
Time frame: 0-24h

2 secondary outcomes

T1/2
Time frame: 0-24h
Tmax
Time frame: 0-24h

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2016.
Individual participant dataSharing planned: No

Related trials for Low Back Pain

Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific Low Back Pain
Nonspecific Low Back Pain
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Yoon Yo Ran, M.D., Ph.D. principal investigator

Kyungpook National University Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing fasting condition and fed condition in people with Low Back Pain, run by NVP Healthcare at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

AUC (time frame: 0-24h). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01885520.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2016.