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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Cresto; Drug: Olmetec; Drug: Cresto, Olmetec

• Registration Number: NCT01415466
• Lead Sponsor: Daewoong Pharmaceutical Co. LTD.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08
• Study First Submitted: 2011-08-09
• Study First Submitted QC: 2011-08-10
• Study First Posted: 2011-08-12
• Primary Completion: 2011-09
• Study Completion: 2011-10
• Status Verified: 2012-04
• Last Update Submitted: 2012-04-02
• Last Update Posted: 2012-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 36

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
R	Cresto	multiple dose of Rosuvastatin 20mg
O	Olmetec	multiple dose of CS-866 40mg
R+O	Cresto, Olmetec	multiple dose of the combination of Rosuvastatin 20mg and CS-866 40mg

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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)

Trial Locations

Locations (1)

Yonsei University Health System (Yuhs); 🇰🇷 Seoul, Korea, Republic of