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

NCT ID: NCT01885520

Last Updated: 2016-03-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2013-07-31

Brief Summary

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

Detailed Description

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eperisone hydrochloride(muscle relaxant)

Conditions

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Low Back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

NONE

Study Groups

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fasting condition

eperisone SR administrated under fasting condition

Group Type EXPERIMENTAL

fasting condition

Intervention Type DIETARY_SUPPLEMENT

eperisone SR tablet 75mg administrated under fasting

Fed condition

eperisone SR administrated under fed condition

Group Type ACTIVE_COMPARATOR

fed condition

Intervention Type DIETARY_SUPPLEMENT

eperisone SR tablet 75mg administrated fed condition

Interventions

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fasting condition

eperisone SR tablet 75mg administrated under fasting

Intervention Type DIETARY_SUPPLEMENT

fed condition

eperisone SR tablet 75mg administrated fed condition

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Healthy male subjects age between 20 and 55 signed informed consent

Exclusion Criteria

* Hypotension or hypertension has a history of allergy reaction of this drug or other drugs
Minimum Eligible Age

20 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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NVP Healthcare

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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

Role: PRINCIPAL_INVESTIGATOR

Kyungpook National University Hospital

Locations

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Kyungpook National University Hospital

Jung-gu, Daegu, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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NVP-EPT-PK-02

Identifier Type: -

Identifier Source: org_study_id

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