NCT01509196

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started Nov 2011

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

November 1, 2011

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 10, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 12, 2012

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
Last Updated

March 29, 2012

Status Verified

March 1, 2012

Enrollment Period

1 month

First QC Date

January 10, 2012

Last Update Submit

March 28, 2012

Conditions

Healthy

Keywords

Fenofibric acidHIP0901Lipidilsupra

Outcome Measures

Primary Outcomes (2)

  • AUC of Fenofibric acid

    0-96 hrs

  • Cmax of Fenofibric acid

    0-96 hrs

Study Arms (2)

HIP0901

EXPERIMENTAL

Fenofibric acid

Drug: HIP0901 / Lipidilsupra

Lipidilsupra

ACTIVE COMPARATOR

Fenofibrate

Drug: HIP0901 / Lipidilsupra

Interventions

HIP0901 / LipidilsupraDRUG

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

HIP0901Lipidilsupra

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

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

January 10, 2012

First Posted

January 12, 2012

Study Start

November 1, 2011

Primary Completion

December 1, 2011

Study Completion

February 1, 2012

Last Updated

March 29, 2012

Record last verified: 2012-03

Locations

KR(1)