A Bioequivalence Study Comparing HIP0901 Capsule With Lipidilsupra Tablet

Open-label, Randomized Comparative Study to Evaluate the Pharmacokinetic Characteristics of Fenofibric Acid Between Lipidilsupra Tablet and HIP0901 Capsule in Healthy Male Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01509196

Enrollment

Registered

2012-01-12

Start date

2011-11-30

Completion date

2012-02-29

Last updated

2012-03-29

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

Conditions

Healthy

Keywords

Fenofibric acid, HIP0901, Lipidilsupra

Brief summary

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

Interventions

DRUGHIP0901 / Lipidilsupra

HIP0901 capsule(Fenofibric acid, 135mg) / Lipidilsupra tablet(Fenofibrate, 160mg)

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

20 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
AUC of Fenofibric acid	0-96 hrs
Cmax of Fenofibric acid	0-96 hrs

Countries

South Korea

Outcome results

None listed

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