Healthy
Conditions
Brief summary
The purpose of this study is to evaluate the pharmacokinetics profile and drug-drug interaction between rosuvastatin and CS-866 in healthy male volunteers.
Sponsors
Yonsei University
Daewoong Pharmaceutical Co. LTD.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
20 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy adult male volunteers aged 20 to 50 years 2. A subject who provided written informed consent to participate in this study and cooperative with regard to compliance with study related constraints
Exclusion criteria
1. A subject who had any allergic history to any drug. 2. A subject with sign or symptoms or previously diagnosed disease of liver, kidney, neurology, respiratory, endocrinology, hematology, cardiovascular, genitourinary, psychology, ophthalmic, dermatology and gastrointestinal function or other significant diseases 3. History or suspicion of current drug abuse 4. A subject who had received treatment with below listed drug within specified period prior to the first dose of study medication * Within 1 month: drug known CYP inducer or inhibitor * Within 2 weeks: Prescribed or herbal medicine * Within 1 weeks: OTC medicine * Within 2 days: Consumption of caffeine 5. A subject who had participated in any other clinical study within the last 2 weeks 6. A subject from whom over 400mL of blood was sampled(whole blood donation) within last 2 weeks or plasma/platelet donation within 1 month.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUCtau | Multiple blood samples will be collected for 72 hours after last dosing in each of the periods.((in case of CS-866, for 48 hours) |
| Css,max | Multiple blood samples will be collected for 72 hours after last dosing in each of the periods.(in case of CS-866, for 48 hours) |
Secondary
| Measure | Time frame |
|---|---|
| AUCss,last | Multiple blood samples will be collected for 72 hours after last dosing in each of the periods. (in case of CS-866, for 48 hours) |
| AUCss,inf | Multiple blood samples will be collected for 72 hours after last dosing in each of the periods. (in case of CS-866, for 48 hours) |
| Css,min | Multiple blood samples will be collected for 72 hours after last dosing in each of the periods. (in case of CS-866, for 48 hours) |
| T1/2 | Multiple blood samples will be collected for 72 hours after last dosing in each of the periods. (in case of CS-866, for 48 hours) |
Countries
South Korea
Outcome results
None listed