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

Daewoong Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Cresto, Olmetec; Drug: Cresto; Drug: Olmetec

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01415466

DW_DWJ1276001

Details and patient eligibility

About

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

Enrollment: 36 patients

Sex: Male

Ages: 20 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

36 participants in 3 patient groups

R

Experimental group

Description:

multiple dose of Rosuvastatin 20mg

Treatment:

Drug: Cresto

O

Experimental group

Description:

multiple dose of CS-866 40mg

Treatment:

Drug: Olmetec

R+O

Experimental group

Description:

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

Treatment:

Drug: Cresto, Olmetec