Pharmacokinetic Study of Livalo® Fixed Combination Drug in Healthy Subjects

Phase 1

Completed

• Conditions: Hyperlipidemia; Hypertension
• Interventions: Drug: Pitavastatin, Valsartan; Drug: Livalo® fixed combination drug

• Registration Number: NCT01406431
• Lead Sponsor: JW Pharmaceutical

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 available

Study Timeline

• Study First Submitted: 2011-07-26
• Study First Submitted QC: 2011-07-28
• Study Start: 2011-08
• Primary Completion: 2011-08
• Study First Posted: 2011-08-01
• Study Completion: 2012-10
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-01
• Last Update Posted: 2013-01-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 48

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Pitavastatin + Valsartan	Pitavastatin, Valsartan	Intervention: Drug: Pitavastatin, Valsartan
Livalo fixed combination drug	Livalo® fixed combination drug	Intervention: Drug: Livalo® fixed combination drug

Primary Outcome Measures

Name	Time	Method
Cmax of study drugs after single oral administration	0-48hrs
AUClast of study drugs after single oral administration	0-48hrs

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of