Clinical Trial to Evaluate the Effect of Food on the Pharmacokinetic Characteristics of HIP0901 Capsule

Open-label, Randomized Study to Evaluate the Effect of Food on the Pharmacokinetic Characteristics of Fenofibric Acid for HIP0901 Capsule in Healthy Male Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01555398

Enrollment

Registered

2012-03-15

Start date

2012-02-29

Completion date

2012-05-31

Last updated

2013-04-08

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, food effect

Brief summary

The purpose of this study is to evaluate the effect of food on the pharmacokinetic characteristics of fenofibric acid for HIP0901 capsule.

Interventions

DIETARY_SUPPLEMENTHIP0901 capsule (Fenofibric acid) Fasting conditions/ Fed conditions

The study drug(HIP0901 capsule(Fenofibric acid, 135mg)) will be administrated under fed or fasting conditions

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