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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
History of Changes
  Purpose

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


Condition Intervention Phase
Healthy Volunteers
 Drug: Cresto
Drug: Olmetec
Drug: DWJ1276
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official 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

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 58
Study Start Date: January 2012
Study Completion Date: March 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Rosuvastatin+Olmesartan
single dose of Rosuvastatin 20mg and olmesartan medoxomil(CS-866) 40mg
 Drug: Cresto
tablet, rosuvastatin 20mg
Drug: Olmetec
tablet, olmesartan medoxomil(CS-866) 40mg
Experimental: DWJ1276
Single dose of DWJ1276
 Drug: DWJ1276
tablet, Rosuvastatin 20mg and olmesartan medoxomil 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01493856

Locations
Korea, Republic of
Yonsei University Health System (Yuhs)
Seoul, Korea, Republic of
Sponsors and Collaborators
Daewoong Pharmaceutical Co. LTD.
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: NCT01493856     History of Changes
Other Study ID Numbers: DW_DWJ1276002
Study First Received: December 13, 2011
Last Updated: April 2, 2012
Health Authority: Korea: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 23, 2013