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

NVP Healthcare

Status and phase: Completed; Phase 1

Conditions: Low Back Pain

Treatments: Dietary Supplement: fed condition; Dietary Supplement: fasting condition

Study type: Interventional

Funder types: Industry

Identifiers

NCT01885520

NVP-EPT-PK-02

Details and patient eligibility

About

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

Full description

eperisone hydrochloride(muscle relaxant)

Enrollment: 28 patients

Sex: Male

Ages: 20 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

28 participants in 2 patient groups

fasting condition

Experimental group

Description:

eperisone SR administrated under fasting condition

Treatment:

Dietary Supplement: fasting condition

Fed condition

Active Comparator group

Description:

eperisone SR administrated under fed condition

Treatment:

Dietary Supplement: fed condition