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
1 other identifier
interventional
58
1 country
1
Brief Summary
The purpose of this study is to evaluate the safety and pharmacokinetic characteristics of combination of rosuvastatin and CS-866 and DWJ1276 alone.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 healthy-volunteers
Started Jan 2012
Shorter than P25 for phase_1 healthy-volunteers
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 13, 2011
CompletedFirst Posted
Study publicly available on registry
December 16, 2011
CompletedStudy Start
First participant enrolled
January 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2012
CompletedApril 4, 2012
April 1, 2012
1 month
December 13, 2011
April 2, 2012
Conditions
Outcome Measures
Primary Outcomes (2)
AUClast
18 time points up to 72 hours
Cmax
18 time points up to 72 hours
Secondary Outcomes (4)
AUCinf
18 time points up to 72 hours
T1/2
18 time points up to 72 hours
%AUCextra
18 time points up to 72 hours
Tmax
18 time points up to 72 hours
Study Arms (2)
Rosuvastatin+Olmesartan
ACTIVE COMPARATORsingle dose of Rosuvastatin 20mg and olmesartan medoxomil(CS-866) 40mg
DWJ1276
EXPERIMENTALSingle dose of DWJ1276
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Yonsei University Health System (Yuhs)
Seoul, South Korea
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kyungsoo Park, M.D., Ph.D.
YONSEI UNIVERSITY HEALTH SYSTEM (YUHS)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 13, 2011
First Posted
December 16, 2011
Study Start
January 1, 2012
Primary Completion
February 1, 2012
Study Completion
March 1, 2012
Last Updated
April 4, 2012
Record last verified: 2012-04