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Completed

NCT Number: NCT01415466

Pharmacokinetics and Drug Interaction Study 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.

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Key information

Conditions

Healthy

Age range

20 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Yonsei University Health System (Yuhs)

Seoul, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cresto

Drug

tablet, 20mg

Olmetec

Drug

tablet, 40mg

Cresto, Olmetec

Drug

tablet, 20mg and 40mg

Primary outcomes

  1. 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)

  2. 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 outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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)

Sponsors and collaborators

Lead sponsor

Daewoong Pharmaceutical Co. LTD.

Industry

Collaborators

  • Yonsei University

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Aug 12, 2011
Registry last updated
Apr 4, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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