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

This study has been completed.
Sponsor:
Collaborator:
Yonsei University
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

August 9, 2011
April 2, 2012
August 2011
September 2011   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01415466 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Pharmacokinetics and Drug Interaction Study Between Rosuvastatin and CS-866 in Healthy Male Volunteers
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

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

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Healthy
  • Drug: Cresto
    tablet, 20mg
  • Drug: Olmetec
    tablet, 40mg
  • Drug: Cresto, Olmetec
    tablet, 20mg and 40mg
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
36
October 2011
September 2011   (final data collection date for primary outcome measure)

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.
Male
20 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01415466
DW_DWJ1276001
No
Daewoong Pharmaceutical Co. LTD.
Daewoong Pharmaceutical Co. LTD.
Yonsei University
Principal Investigator: Kyungsoo Park, M.D., Ph.D. YONSEI UNIVERSITY HEALTH SYSTEM (YUHS)
Daewoong Pharmaceutical Co. LTD.
April 2012

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