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Completed

NCT Number: NCT01493856

A Clinical Trial to Compare the Safety and Pharmacokinetic Characteristics of Combination of Rosuvastatin and CS-866 and DWJ1276

The purpose of this study is to evaluate the safety and pharmacokinetic characteristics of combination of rosuvastatin and CS-866 and DWJ1276 alone.

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Key information

Conditions

Healthy Volunteers

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, rosuvastatin 20mg

Olmetec

Drug

tablet, olmesartan medoxomil(CS-866) 40mg

DWJ1276

Drug

tablet, Rosuvastatin 20mg and olmesartan medoxomil 40mg

Primary outcomes

  1. AUClast

    Time frame: 18 time points up to 72 hours

  2. Cmax

    Time frame: 18 time points up to 72 hours

Secondary outcomes

  1. AUCinf

    Time frame: 18 time points up to 72 hours

  2. T1/2

    Time frame: 18 time points up to 72 hours

  3. %AUCextra

    Time frame: 18 time points up to 72 hours

  4. Tmax

    Time frame: 18 time points up to 72 hours

Sponsors and collaborators

Lead sponsor

Daewoong Pharmaceutical Co. LTD.

Industry

Registry information

Official study title

A Randomized, Open Label, Single-Dose, 2-Way Cross-over Clinical Trial to Compare the Safety and Pharmacokinetic Characteristics of Combination of Rosuvastatin and CS-866 and DWJ1276 in Healthy Male Volunteers

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Dec 16, 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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