Drug Interaction and Safety Between Pitavastatin and Valsartan (CWP-PTV-101)
Phase 1
Completed
- Conditions
- Healthy
- Interventions
- Drug: Multiple Oral Dose of
- Registration Number
- NCT01232049
- Lead Sponsor
- Asan Medical Center
- Brief Summary
This study is designed to evaluate a pharmacokinetic drug interaction and safety between Pitavastatin and Valsartan in healthy male subjects
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 24
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description A Multiple Oral Dose of Pitavastatin 4mg B Multiple Oral Dose of Valsartan 320mg C Multiple Oral Dose of Pitavastatin 4mg + Valsartan 320mg
- Primary Outcome Measures
Name Time Method Safety (normal results for safety tests) 39days Adverse events Physical examination, vital signs
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Asan Medical Center
🇰🇷Seoul, Korea, Republic of