Single dose open-label comparative pharmacokinetic study to assess the pharmacokinetic characteristics of Irbesartan and Atorvastatin between Irbesartan/Atorvastatin combination tablet and coadministration of Irbesartan and Atorvastatin tablets in healthy male subjects
Not Applicable
Recruiting
- Conditions
- Not Applicable
- Registration Number
- KCT0000263
- Lead Sponsor
- Hanmi Pharm
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Male
- Target Recruitment
- 52
Inclusion Criteria
Age between 20 and 45
weight : over 45kg and in the range of ±20% of IBW
Have to give their consent to participating clinical trial by oneself
Exclusion Criteria
Has a medical history of hypersensitivity to atorvastatin or irbesartan
severe Hypotension
Not eligible for subject in health examination
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method AUC of Irbesartan;AUC of Atorvastatin;Cmx of Irbesartan;Cmax of Atorvastatin
- Secondary Outcome Measures
Name Time Method AUC of 2-hydroxyatorvastatin