A Clinical Trial to Compare the Safety and Pharmacokinetic Characteristics of Combination of Rosuvastatin and CS-866 and DWJ1276
NCT ID: NCT01493856
Last Updated: 2012-04-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
58 participants
INTERVENTIONAL
2012-01-31
2012-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
NONE
Study Groups
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Rosuvastatin+Olmesartan
single dose of Rosuvastatin 20mg and olmesartan medoxomil(CS-866) 40mg
Cresto
tablet, rosuvastatin 20mg
Olmetec
tablet, olmesartan medoxomil(CS-866) 40mg
DWJ1276
Single dose of DWJ1276
DWJ1276
tablet, Rosuvastatin 20mg and olmesartan medoxomil 40mg
Interventions
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Cresto
tablet, rosuvastatin 20mg
Olmetec
tablet, olmesartan medoxomil(CS-866) 40mg
DWJ1276
tablet, Rosuvastatin 20mg and olmesartan medoxomil 40mg
Eligibility Criteria
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Inclusion Criteria
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
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.
20 Years
50 Years
MALE
Yes
Sponsors
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Daewoong Pharmaceutical Co. LTD.
INDUSTRY
Responsible Party
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Principal Investigators
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Kyungsoo Park, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
YONSEI UNIVERSITY HEALTH SYSTEM (YUHS)
Locations
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Yonsei University Health System (Yuhs)
Seoul, , South Korea
Countries
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Other Identifiers
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DW_DWJ1276002
Identifier Type: -
Identifier Source: org_study_id
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