Pharmacokinetic Study of Livalo® Fixed Combination Drug i... | NCT01406431

Studies
Pharmacokinetic Study of Livalo® Fixed Combination Drug in Healthy Subjects

NCT01406431

Sponsor

JW Pharmaceutical

Status

Completed

Last Update Posted

Jan 3, 2013Estimated

Enrollment

48Actual

Phase

Phase 1

Conditions

Hyperlipidemia
Hypertension

Interventions

Pitavastatin, Valsartan
Livalo® fixed combination drug

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

Jan 2013

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

Aug 2011

Primary Completion Date

Aug 2011Actual

Completion Date

Oct 2012Actual

First Submitted Date

Jul 26, 2011

First Submission Date that Met QC Criteria

Jul 28, 2011

First Posted Date

Aug 1, 2011Estimated

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

Jan 1, 2013

Last Update Posted Date

Jan 3, 2013Estimated

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 compare pharmacokinetics between Pitavastatin and Valsartan co-administration and Livalo fixed combination drug in healthy male subjects.

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

48Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Pitavastatin + Valsartan	Active Comparator	Intervention: Drug: Pitavastatin, Valsartan	Drug: Pitavastatin, Valsartan
Livalo fixed combination drug	Experimental	Intervention: Drug: Livalo® fixed combination drug	Drug: Livalo® fixed combination drug

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pitavastatin, Valsartan	Drug	Pitavastatin 4mg(2 tablets), Valsartan 160mg(1 tablet)	Pitavastatin + Valsartan

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Cmax of study drugs after single oral administration		0-48hrs
AUClast of study drugs after single oral administration		0-48hrs

Secondary Outcomes

Measure	Description	Time Frame
AUCinf, Tmax and t1/2β of study drugs after single oral administration		0-48hrs

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy male volunteers
Age 20-55 years at the time of Screening
BMI 19-26 kg/m2 at the time of Screening

Exclusion Criteria:

Received other investigational drug within 90 days prior to the first dose of study drug

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kyun Seop Bae, MD	Asan Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Asan Medical Center		Seoul			South Korea

Condition Browse Module

MeSH Terms

ID	Term
D006949	Hyperlipidemias
D006973	Hypertension

Ancestor Terms

ID	Term
D050171	Dyslipidemias
D052439	Lipid Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C108475	pitavastatin
D000068756	Valsartan

Ancestor Terms

ID	Term
D013777	Tetrazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided