Pharmacokinetic Study of Livalo® Fixed Combination Drug in Healthy Subjects

Hypertension Clinical Trial

Official title:

A Single Dose, Sequence-randomized, Open-label, 2x2 Crossover Study to Compare Pharmacokinetics Between Pitavastatin and Valsartan Co-administration and Livalo® Fixed Combination Drug in Healthy Male Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01406431
• Other study ID #: JW-PTV-102
• Status: Completed
• Phase: Phase 1
• First received: July 26, 2011
• Last updated: January 1, 2013
• Start date: August 2011
• Est. completion date: October 2012

Study information

• Verified date: January 2013
• Source: JW Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: October 2012
• Est. primary completion date: August 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 55 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Hyperlipidemia
• Hyperlipidemias
• Hypertension

Intervention

Drug:
• Pitavastatin, Valsartan
Pitavastatin 4mg(2 tablets), Valsartan 160mg(1 tablet)
• Livalo® fixed combination drug
Livalo® fixed combination drug(1 tablet)

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
JW Pharmaceutical

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax of study drugs after single oral administration		0-48hrs	Yes
Primary	AUClast of study drugs after single oral administration		0-48hrs	Yes
Secondary	AUCinf, Tmax and t1/2ß of study drugs after single oral administration		0-48hrs	Yes