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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Male

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Asan Medical Center
• Collaborator: JW Pharmaceutical
• Treatments: Pitavastatin; Valsartan

Criteria

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.