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

Daewoong Pharmaceutical Co. LTD.1 site in 1 country36 target enrollmentAugust 2011

ConditionsHealthy

InterventionsCresto Olmetec Cresto, Olmetec

DrugsCresto Olmetec Cresto, Olmetec

Overview

Phase: Phase 1
Intervention: Cresto
Conditions: Healthy
Sponsor: Daewoong Pharmaceutical Co. LTD.
Enrollment: 36
Locations: 1
Primary Endpoint: AUCtau
Status: Completed
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

August 2011

End Date

October 2011

Last Updated

14 years ago

Study Type

Interventional

Study Design

Crossover

Sex

Male

Investigators

Sponsor

Daewoong Pharmaceutical Co. LTD.

Responsible Party

Sponsor

Eligibility Criteria

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.

Arms & Interventions

R

multiple dose of Rosuvastatin 20mg

Intervention: Cresto

O

multiple dose of CS-866 40mg

Intervention: Olmetec

R+O

multiple dose of the combination of Rosuvastatin 20mg and CS-866 40mg

Intervention: Cresto, Olmetec

Outcomes

Primary Outcomes

AUCtau

Time Frame: 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

Time Frame: 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 Outcomes

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))