Status:
COMPLETED
Drug Interaction and Safety Between Pitavastatin and Valsartan (CWP-PTV-101)
Lead Sponsor:
Asan Medical Center
Collaborating Sponsors:
JW Pharmaceutical
Conditions:
Healthy
Eligibility:
MALE
20-50 years
Phase:
PHASE1
Brief Summary
This study is designed to evaluate a pharmacokinetic drug interaction and safety between Pitavastatin and Valsartan in healthy male subjects
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT01232049
Start Date
October 1 2010
Last Update
June 27 2011
Active Locations (1)
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1
Asan Medical Center
Seoul, South Korea