A Bioequivalence Study Comparing HIP0901 Capsule With Lipidilsupra Tablet

Hanmi Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: HIP0901 / Lipidilsupra

Study type: Interventional

Funder types: Industry

Identifiers

NCT01509196

HM-FEN-101

Details and patient eligibility

About

The purpose of this study is to evaluate pharmacokinetics and safety after oral administration of HIP0901 capsules and Lipidilsupra tablets.

Enrollment: 28 patients

Sex: Male

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy male volunteers, age between 20 and 45
• Informed of the investigational nature of this study and voluntarily agree to participate in this study
• Weight>50kg, BMI of >18kg/m2 and <27kg/m2 subject

Exclusion criteria

• Acute disease within 28 days prior to start of study drug administration
• Use of any prescription medication within 14 days prior to Day 1
• Use of any medication within 7 days prior to Day 1
• Has a severe medical history of hypersensitivity to fibric acid derivative
• Participation in another clinical study within 30 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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28 participants in 2 patient groups

HIP0901

Experimental group

Description:

Fenofibric acid

Treatment:

Drug: HIP0901 / Lipidilsupra

Lipidilsupra

Active Comparator group

Description:

Fenofibrate

Treatment:

Drug: HIP0901 / Lipidilsupra