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
  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
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: 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) ] [ 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 ]

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) ] [ 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 ]

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

Ages Eligible for Study:   20 Years to 50 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Daewoong Pharmaceutical Co. LTD.
ClinicalTrials.gov Identifier: NCT01415466     History of Changes
Other Study ID Numbers: DW_DWJ1276001
Study First Received: August 9, 2011
Last Updated: April 2, 2012
Health Authority: Korea: Food and Drug Administration

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

ClinicalTrials.gov processed this record on October 01, 2014