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

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.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01885520

Acronym

eperisone

Enrollment

Registered

2013-06-25

Start date

2013-07-31

Completion date

2013-07-31

Last updated

2016-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Low Back Pain

Keywords

low back pain

Brief summary

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)

Interventions

DIETARY_SUPPLEMENTfasting condition

eperisone SR tablet 75mg administrated under fasting

DIETARY_SUPPLEMENTfed condition

eperisone SR tablet 75mg administrated fed condition

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

20 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026