Pharmacokinetics and Drug Interaction Study Between Rosuvastatin and CS-866 in Healthy Male Volunteers

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the pharmacokinetics profile and drug-drug interaction between rosuvastatin and CS-866 in healthy male volunteers.

Official Title
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A Randomized, Open Label, Multiple-Dose, Cross-over Clinical Study to Investigate Pharmacokinetics and Drug-Drug Interaction Between Rosuvastatin and CS-866 in Healthy Male Volunteers

Conditions
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Healthy

Intervention / Treatment
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* Drug: Cresto
* Drug: Olmetec
* Drug: Cresto, Olmetec


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy adult male volunteers aged 20 to 50 years A subject who provided written informed consent to participate in this study and cooperative with regard to compliance with study related constraints Exclusion Criteria: A subject who had any allergic history to any drug. 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 History or suspicion of current drug abuse 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 A subject who had participated in any other clinical study within the last 2 weeks A subject from whom over 400mL of blood was sampled(whole blood donation) within last 2 weeks or plasma/platelet donation within 1 month.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: R<br>multiple dose of Rosuvastatin 20mg | Drug: Cresto<br>* tablet, 20mg<br>|
| Experimental: O<br>multiple dose of CS-866 40mg | Drug: Olmetec<br>* tablet, 40mg<br>|
| Experimental: R+O<br>multiple dose of the combination of Rosuvastatin 20mg and CS-866 40mg | Drug: Cresto, Olmetec<br>* tablet, 20mg and 40mg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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) |