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

JW Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Hypertension; Hyperlipidemia

Treatments: Drug: Pitavastatin, Valsartan; Drug: Livalo fixed combination drug

Study type: Interventional

Funder types: Industry

Identifiers

NCT01764178

JW-PTV-102A

Details and patient eligibility

About

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

Enrollment: 52 patients

Sex: Male

Ages: 20 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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52 participants in 2 patient groups

Livalo fixed combination drug

Experimental group

Description:

Livalo fixed combination drug(Pitavastatin + Valsartan)

Treatment:

Drug: Livalo fixed combination drug

Pitavastatin + Valsartan

Active Comparator group

Description:

Pitavastatin, Valsartan

Treatment:

Drug: Pitavastatin, Valsartan