NCT01493856
Completed
Phase 1
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
Daewoong Pharmaceutical Co. LTD.1 site in 1 country58 target enrollmentJanuary 2012
Overview
- Phase
- Phase 1
- Intervention
- Cresto
- Conditions
- Healthy Volunteers
- Sponsor
- Daewoong Pharmaceutical Co. LTD.
- Enrollment
- 58
- Locations
- 1
- Primary Endpoint
- AUClast
- Status
- Completed
- Last Updated
- 14 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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 Criteria
- •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.
Arms & Interventions
Rosuvastatin+Olmesartan
single dose of Rosuvastatin 20mg and olmesartan medoxomil(CS-866) 40mg
Intervention: Cresto
Rosuvastatin+Olmesartan
single dose of Rosuvastatin 20mg and olmesartan medoxomil(CS-866) 40mg
Intervention: Olmetec
DWJ1276
Single dose of DWJ1276
Intervention: DWJ1276
Outcomes
Primary Outcomes
AUClast
Time Frame: 18 time points up to 72 hours
Cmax
Time Frame: 18 time points up to 72 hours
Secondary Outcomes
- 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 Sites (1)
Loading locations...
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