Drug Interaction and Safety Between Pitavastatin and Valsartan (CWP-PTV-101)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Brief Summary

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This study is designed to evaluate a pharmacokinetic drug interaction and safety between Pitavastatin and Valsartan in healthy male subjects

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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A

Pitavastatin 4mg

Group Type EXPERIMENTAL

Multiple Oral Dose of

Intervention Type DRUG

Pitavastatin 4mg

B

Valsartan 320mg

Group Type EXPERIMENTAL

Multiple Oral Dose of

Intervention Type DRUG

Valsartan 320mg

C

Pitavastatin 4mg + Valsartan 320mg

Group Type EXPERIMENTAL

Multiple Oral Dose of

Intervention Type DRUG

Pitavastatin 4mg

Multiple Oral Dose of

Intervention Type DRUG

Valsartan 320mg

Interventions

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Multiple Oral Dose of

Pitavastatin 4mg

Intervention Type DRUG

Multiple Oral Dose of

Valsartan 320mg

Intervention Type DRUG

Other Intervention Names

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Livalo® Diovan®

Eligibility Criteria

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Inclusion Criteria

* Adult males aged 20 to 50 years at screening.
* No significant congenital/chronic disease. No symptoms in physical examination.
* Appropriate subjects as determined by past medical history, laboratory tests, serology and urinalysis.
* Be able to understand the objective, method of the study, the characteristics of investigational drug, and comply with the requirement of the study. Subject must provide written informed consent prior to study participation.

Exclusion Criteria

* History or presence of liver, kidney, or nervous system disease, respiratory disorders, endocrinological disorders, hemato-oncologic, cardiovascular or psychiatric or cognitive disorders.
* History of gastrointestinal disorders (bleeding, ulceration, hemorrhoids, piles) or disorders of absorption, distribution, metabolism, excretion.
* History of known hypersensitivity to drugs including valsartan and pitavastatin.

Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes