NCT01555398

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Feb 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

March 13, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 15, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

April 8, 2013

Status Verified

April 1, 2013

Enrollment Period

29 days

First QC Date

March 13, 2012

Last Update Submit

April 5, 2013

Conditions

Healthy

Keywords

Fenofibric acidHIP0901food effect

Outcome Measures

Primary Outcomes (2)

  • AUC of Fenofibric acid

    0-96 hrs

  • Cmax of Fenofibric acid

    0-96 hrs

Study Arms (2)

Fasting conditions

EXPERIMENTAL

Investigational product administrated under fasting condition.

Dietary Supplement: HIP0901 capsule (Fenofibric acid) Fasting conditions/ Fed conditions

Fed conditions

ACTIVE COMPARATOR

Investigational product administrated 30min after starting a high-fat breakfast.

Dietary Supplement: HIP0901 capsule (Fenofibric acid) Fasting conditions/ Fed conditions

Interventions

HIP0901 capsule (Fenofibric acid) Fasting conditions/ Fed conditionsDIETARY_SUPPLEMENT

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

Fasting conditionsFed conditions

Eligibility Criteria

Age20 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Korea University Anam Hospital

Seoul, South Korea

Location

MeSH Terms

Interventions

fenofibric acid

Study Officials

  • Ji-Young Park, MD, PhD

    Korea University Anam Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 13, 2012

First Posted

March 15, 2012

Study Start

February 1, 2012

Primary Completion

March 1, 2012

Study Completion

May 1, 2012

Last Updated

April 8, 2013

Record last verified: 2013-04

Locations

KR(1)