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

This study has been completed.

Sponsor:

Collaborator:

Yonsei University Health System

Information provided by (Responsible Party):

Daewoong Pharmaceutical Co. LTD.

ClinicalTrials.gov Identifier:

NCT01415466

First received: August 9, 2011

Last updated: April 2, 2012

Last verified: April 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

August 9, 2011

Last Updated Date

April 2, 2012

Start Date ^ICMJE

August 2011

Primary Completion Date

September 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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) ] [ Designated as safety issue: No ]
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) ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01415466 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

AUCss,last [ 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) ] [ Designated as safety issue: No ]
AUCss,inf [ 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) ] [ Designated as safety issue: No ]
Css,min [ 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) ] [ Designated as safety issue: No ]
T1/2 [ 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) ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label

Condition ^ICMJE

Healthy

Intervention ^ICMJE

Drug: Cresto
tablet, 20mg
Drug: Olmetec
tablet, 40mg
Drug: Cresto, Olmetec
tablet, 20mg and 40mg

Study Arm (s)

Experimental: R
multiple dose of Rosuvastatin 20mg

Intervention: Drug: Cresto
Experimental: O
multiple dose of CS-866 40mg

Intervention: Drug: Olmetec
Experimental: R+O
multiple dose of the combination of Rosuvastatin 20mg and CS-866 40mg

Intervention: Drug: Cresto, Olmetec

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

October 2011

Primary Completion Date

September 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Male

Ages

20 Years to 50 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Korea, Republic of

Administrative Information

NCT Number ^ICMJE

NCT01415466

Other Study ID Numbers ^ICMJE

DW_DWJ1276001

Has Data Monitoring Committee

Responsible Party

Daewoong Pharmaceutical Co. LTD.

Study Sponsor ^ICMJE

Daewoong Pharmaceutical Co. LTD.

Collaborators ^ICMJE

Yonsei University Health System

Investigators ^ICMJE

Principal Investigator:

Kyungsoo Park, M.D., Ph.D.

YONSEI UNIVERSITY HEALTH SYSTEM (YUHS)

Information Provided By

Daewoong Pharmaceutical Co. LTD.

Verification Date

April 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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