An Open Label, Randomized, 2-Sequence, Multiple-Dose Cross-Over Study to Investigate the Drug-Drug Interaction of Sevikar and Crestor in Healthy Adult Volunteers
Not Applicable
Completed
- Conditions
- Not Applicable
- Registration Number
- KCT0001058
- Lead Sponsor
- Daewoong Pharmaceutical
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Male
- Target Recruitment
- 32
Inclusion Criteria
1.Healthy male subjects aged 19 - 55 years
2.A body mass index in the range 19 - 27 kg/m2
3.Willingness to participate during the entire study period
4.Written informed consent after being fully informed about the study procedures
Exclusion Criteria
1.Any past medical history of hepatic, renal, gastrointestinal, respiratory, endocrine, psychiatric, neurologic, haemato-oncologic or cardiovascular disease
2.History of clinically significant drug hypersensitivity
3.Use of medication within 7 days before the first dose
4.Heavy drinker (>140 g/week)
5.Whole blood donation during 60 days before the study
6.Judged not eligible for study participation by investigator
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method AUCt, Css,max
- Secondary Outcome Measures
Name Time Method tss,max, Css,min