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Completed

NCT Number: NCT01885520

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

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

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Key information

Conditions

Low Back Pain Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Kyungpook National University Hospital

Jung-gu, Daegu, 700-721, South Korea

About this study

eperisone hydrochloride(muscle relaxant)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

fasting condition

Dietary Supplement

eperisone SR tablet 75mg administrated under fasting

fed condition

Dietary Supplement

eperisone SR tablet 75mg administrated fed condition

Primary outcomes

  1. AUC

    Time frame: 0-24h

  2. Cmax

    Time frame: 0-24h

Secondary outcomes

  1. T1/2

    Time frame: 0-24h

  2. Tmax

    Time frame: 0-24h

Sponsors and collaborators

Lead sponsor

NVP Healthcare

Industry

Registry information

Official study 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.

Acronym: eperisone

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Jun 25, 2013
Registry last updated
Mar 25, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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