Status:
COMPLETED
A Clinical Trial to Compare the Safety and Pharmacokinetic Characteristics of Combination of Rosuvastatin and CS-866 and DWJ1276
Lead Sponsor:
Daewoong Pharmaceutical Co. LTD.
Conditions:
Healthy Volunteers
Eligibility:
MALE
20-50 years
Phase:
PHASE1
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.
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2012
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT01493856
Start Date
January 1 2012
End Date
March 1 2012
Last Update
April 4 2012
Active Locations (1)
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1
Yonsei University Health System (Yuhs)
Seoul, South Korea