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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Daewoong Pharmaceutical Co. LTD.
ClinicalTrials.gov Identifier:
NCT01493856
First received: December 13, 2011
Last updated: April 2, 2012
Last verified: April 2012

December 13, 2011
April 2, 2012
January 2012
February 2012   (final data collection date for primary outcome measure)
  • AUClast [ Time Frame: 18 time points up to 72 hours ] [ Designated as safety issue: No ]
  • Cmax [ Time Frame: 18 time points up to 72 hours ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01493856 on ClinicalTrials.gov Archive Site
  • AUCinf [ Time Frame: 18 time points up to 72 hours ] [ Designated as safety issue: No ]
  • T1/2 [ Time Frame: 18 time points up to 72 hours ] [ Designated as safety issue: No ]
  • %AUCextra [ Time Frame: 18 time points up to 72 hours ] [ Designated as safety issue: No ]
  • Tmax [ Time Frame: 18 time points up to 72 hours ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Clinical Trial to Compare the Safety and Pharmacokinetic Characteristics of Combination of Rosuvastatin and CS-866 and DWJ1276
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

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

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Healthy Volunteers
  • Drug: Cresto
    tablet, rosuvastatin 20mg
  • Drug: Olmetec
    tablet, olmesartan medoxomil(CS-866) 40mg
  • Drug: DWJ1276
    tablet, Rosuvastatin 20mg and olmesartan medoxomil 40mg
  • Active Comparator: Rosuvastatin+Olmesartan
    single dose of Rosuvastatin 20mg and olmesartan medoxomil(CS-866) 40mg
    Interventions:
    • Drug: Cresto
    • Drug: Olmetec
  • Experimental: DWJ1276
    Single dose of DWJ1276
    Intervention: Drug: DWJ1276
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
58
March 2012
February 2012   (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
 
NCT01493856
DW_DWJ1276002
No
Daewoong Pharmaceutical Co. LTD.
Daewoong Pharmaceutical Co. LTD.
Not Provided
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