Pharmacokinetic Study of Livalo® Fixed Combination Drug in Healthy Subjects

Phase 1

Completed

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

• Registration Number: NCT01764178
• 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: 2013-01-01
• Study First Submitted QC: 2013-01-07
• Study First Posted: 2013-01-09
• Study Start: 2013-01-22
• Primary Completion: 2013-03-15
• Study Completion: 2013-12-27
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-08
• Last Update Posted: 2017-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 52

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
Livalo fixed combination drug	Livalo fixed combination drug	Livalo fixed combination drug(Pitavastatin + Valsartan)
Pitavastatin + Valsartan	Pitavastatin, Valsartan	Pitavastatin, Valsartan

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

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