A Bioequivalence Study Comparing HIP0901 Capsule With Lipidilsupra Tablet

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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

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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