To Evaluate the Safety and PK Characteristics in Healthy Volunteers-Livalozet

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01764178

Enrollment

Registered

2013-01-09

Start date

2013-01-22

Completion date

2013-12-27

Last updated

2025-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperlipidemia, Hypertension

Keywords

Pitavastatin, Valsartan

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.

Interventions

DRUGLivalo fixed combination drug

Pitavastatin 4mg / Valsartan 160mg

DRUGPitavastatin, Valsartan

Pitavastatin 4mg, Valsartan 160mg

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

20 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Cmax and AUC of study drugs after single oral administration	0-48hrs

Secondary

Measure	Time frame
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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026