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

JW Pharmaceutical52 enrolled

Overview

The purpose of this study is to compare pharmacokinetics between Pitavastatin and Valsartan co-administration and Livalo fixed combination drug in healthy male subjects.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Hyperlipidemia Hypertension

Interventions

Livalo fixed combination drugDRUG

Pitavastatin 4mg / Valsartan 160mg

Pitavastatin, ValsartanDRUG

Pitavastatin 4mg, Valsartan 160mg

Eligibility

Sex: MALEMin age: 20 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Asan Medical Center

Seoul, South Korea

Outcomes

Primary Outcomes

Cmax and AUC of study drugs after single oral administration

Time frame: 0-48hrs

Secondary Outcomes

AUCinf of study drugs after single oral administration

Time frame: 0-48hrs

t1/2β of study drugs after single oral administration

Time frame: 0-48hrs

Tmax of study drugs after single oral administration

Time frame: 0-48hrs

Data from ClinicalTrials.gov

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