Pharmacokinetics and Drug Interaction Study Between Rosuvastatin and CS-866 in Healthy Male Volunteers
NCT ID: NCT01415466
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
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
36 participants
INTERVENTIONAL
2011-08-31
2011-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Clinical Trial to Compare the Safety and Pharmacokinetic Characteristics of Combination of Rosuvastatin and CS-866 and DWJ1276
NCT01493856
Pharmacokinetics and Drug Interaction Study Between Rosuvastatin and Fenofibric Acid in Healthy Male Volunteers
NCT01964365
Investigation of Pharmacokinetic Interaction Between Rosuvastatin and Olmesartan in Healthy Male Volunteers
NCT01831479
Safety and Pharmacokinetic Comparison of Co-administration and a Combination Drug of Rosuvastatin and Olmesartan in Healthy Male Volunteers
NCT01823900
Influence of OATP1B1 and BRCP Genotype on Rosuvastatin PK, PD and Lipidomics in Hyperlipidemic Patients
NCT01466608
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
R
multiple dose of Rosuvastatin 20mg
Cresto
tablet, 20mg
O
multiple dose of CS-866 40mg
Olmetec
tablet, 40mg
R+O
multiple dose of the combination of Rosuvastatin 20mg and CS-866 40mg
Cresto, Olmetec
tablet, 20mg and 40mg
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Cresto
tablet, 20mg
Olmetec
tablet, 40mg
Cresto, Olmetec
tablet, 20mg and 40mg
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
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
Meet the organizations funding or collaborating on the study and learn about their roles.
Yonsei University
OTHER
Daewoong Pharmaceutical Co. LTD.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Kyungsoo Park, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
YONSEI UNIVERSITY HEALTH SYSTEM (YUHS)
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Yonsei University Health System (Yuhs)
Seoul, , South Korea
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
DW_DWJ1276001
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.