A Bioequivalence Study Comparing HIP0901 Capsule With Lip... | NCT01509196

Studies
A Bioequivalence Study Comparing HIP0901 Capsule With Lipidilsupra Tablet

NCT01509196

Sponsor

Hanmi Pharmaceutical Company Limited

Status

Completed

Last Update Posted

Mar 29, 2012Estimated

Enrollment

28Actual

Phase

Phase 1

Conditions

Healthy

Interventions

HIP0901 / Lipidilsupra

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2011

Primary Completion Date

Dec 2011Actual

Completion Date

Feb 2012Actual

First Submitted Date

Jan 10, 2012

First Submission Date that Met QC Criteria

Jan 10, 2012

First Posted Date

Jan 12, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 28, 2012

Last Update Posted Date

Mar 29, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

28Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
HIP0901	Experimental	Fenofibric acid	Drug: HIP0901 / Lipidilsupra
Lipidilsupra	Active Comparator	Fenofibrate	Drug: HIP0901 / Lipidilsupra

Interventions

Name	Type	Description	Arm Group Labels	Other Names
HIP0901 / Lipidilsupra	Drug	HIP0901 capsule(Fenofibric acid, 135mg) / Lipidilsupra tablet(Fenofibrate, 160mg)	HIP0901 Lipidilsupra

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
AUC of Fenofibric acid		0-96 hrs
Cmax of Fenofibric acid		0-96 hrs

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ji-Young Park, MD, PhD	Korea University Anam Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Korea University Anam Hospital		Seoul			South Korea