Partial Replicated Crossover Clinical Study to Compare Pharmacokinectic Characteristics of Eperisone Hydrochloride and Aceclofenac With HCP1104 Treatment to Those of Co-administration of Eperisone Hydrochloride 50mg Tablet and Aceclofenac 100mg Tablet in Healthy Adult Male Volunteers

Hanmi Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: HCP1104 / Mulex Tab. and Airtal Tab.

Study type: Interventional

Funder types: Industry

Identifiers

NCT01869985

HM-EPAC-102

Details and patient eligibility

About

The purpose of this study is to evaluate pharmacokinetics and safety after oral administration of HCP1104 and Eperisone Hydrochloride plus Aceclofenac.

Full description

The purpose of this study is to evaluate pharmacokinetics and safety after oral administration of HCP1104 and Eperisone Hydrochloride plus Aceclofenac.

Enrollment: 30 patients

Sex: Male

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy male volunteers, age between 20 and 45
• BMI of >20kg/m2 and <28kg/m2 subject
• Informed of the investigational nature of this study and voluntarily agree to participate in this study

Exclusion criteria

• Use of any prescription medication within 14 days prior to Day 1
• Use of any medication within 7 days prior to Day 1
• Participation in another clinical study within 60 days prior to start of study drug administration

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

HCP1104

Experimental group

Description:

HCP1104

Treatment:

Drug: HCP1104 / Mulex Tab. and Airtal Tab.

Mulex Tab. and Airtal Tab.

Active Comparator group

Description:

Eperisone Hydrochloride and Aceclofenac

Treatment:

Drug: HCP1104 / Mulex Tab. and Airtal Tab.