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NCT01764178 Clinical Trial

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 Pitavastatn and Valsartan Co-administration and Livalo Complex Product in Healthy Male Subjects

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01764178
Other study ID # JW-PTV-102A
Secondary ID
Status Completed
Phase Phase 1
First received January 1, 2013
Last updated March 8, 2017
Start date January 22, 2013
Est. completion date December 27, 2013

Study information
Verified date March 2017
Source JW Pharmaceutical
Contact n/a
Is FDA regulated No
Health authority
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 52
Est. completion date December 27, 2013
Est. primary completion date March 15, 2013
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

Related Conditions & MeSH terms

Intervention

Drug:
• Livalo fixed combination drug
Pitavastatin 4mg / Valsartan 160mg
• Pitavastatin, Valsartan
Pitavastatin 4mg, Valsartan 160mg

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 and AUC of study drugs after single oral administration 0-48hrs
Secondary AUCinf of study drugs after single oral administration 0-48hrs
Secondary t1/2ß of study drugs after single oral administration 0-48hrs
Secondary Tmax of study drugs after single oral administration 0-48hrs
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