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

Asan Medical Center

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Multiple Oral Dose of

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01232049

2010-0577

Details and patient eligibility

About

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

Enrollment: 24 estimated patients

Sex: Male

Ages: 20 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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24 participants in 3 patient groups

A

Experimental group

Description:

Pitavastatin 4mg

Treatment:

Drug: Multiple Oral Dose of

Drug: Multiple Oral Dose of

B

Experimental group

Description:

Valsartan 320mg

Treatment:

Drug: Multiple Oral Dose of

Drug: Multiple Oral Dose of

C

Experimental group

Description:

Pitavastatin 4mg + Valsartan 320mg

Treatment:

Drug: Multiple Oral Dose of

Drug: Multiple Oral Dose of