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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01415466
First Posted: August 12, 2011
Last Update Posted: April 4, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Yonsei University
Information provided by (Responsible Party):
Daewoong Pharmaceutical Co. LTD.
  Purpose
The purpose of this study is to evaluate the pharmacokinetics profile and drug-drug interaction between rosuvastatin and CS-866 in healthy male volunteers.

Condition Intervention Phase
Healthy Drug: Cresto Drug: Olmetec Drug: Cresto, Olmetec Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Daewoong Pharmaceutical Co. LTD.:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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) ]
  • 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) ]
  • 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) ]
  • 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) ]

Enrollment: 36
Study Start Date: August 2011
Study Completion Date: October 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: R
multiple dose of Rosuvastatin 20mg
Drug: Cresto
tablet, 20mg
Experimental: O
multiple dose of CS-866 40mg
Drug: Olmetec
tablet, 40mg
Experimental: R+O
multiple dose of the combination of Rosuvastatin 20mg and CS-866 40mg
Drug: Cresto, Olmetec
tablet, 20mg and 40mg

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01415466


Locations
Korea, Republic of
Yonsei University Health System (Yuhs)
Seoul, Korea, Republic of
Sponsors and Collaborators
Daewoong Pharmaceutical Co. LTD.
Yonsei University
Investigators
Principal Investigator: Kyungsoo Park, M.D., Ph.D. YONSEI UNIVERSITY HEALTH SYSTEM (YUHS)
  More Information

Responsible Party: Daewoong Pharmaceutical Co. LTD.
ClinicalTrials.gov Identifier: NCT01415466     History of Changes
Other Study ID Numbers: DW_DWJ1276001
First Submitted: August 9, 2011
First Posted: August 12, 2011
Last Update Posted: April 4, 2012
Last Verified: April 2012

Additional relevant MeSH terms:
Rosuvastatin Calcium
Olmesartan
Olmesartan Medoxomil
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists