A Clinical Trial to Compare the Safety and Pharmacokinetic Characteristics of Combination of Rosuvastatin and CS-866 and DWJ1276

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: Cresto; Drug: DWJ1276; Drug: Olmetec

• Registration Number: NCT01493856
• Lead Sponsor: Daewoong Pharmaceutical Co. LTD.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-12-13
• Study First Submitted QC: 2011-12-14
• Study First Posted: 2011-12-16
• Study Start: 2012-01
• Primary Completion: 2012-02
• Study Completion: 2012-03
• Status Verified: 2012-04
• Last Update Submitted: 2012-04-02
• Last Update Posted: 2012-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 58

Inclusion Criteria

1. Healthy adult male volunteers aged 20 to 50 years
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

1. A subject who had any allergic history to any drug.

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Rosuvastatin+Olmesartan	Cresto	single dose of Rosuvastatin 20mg and olmesartan medoxomil(CS-866) 40mg
DWJ1276	DWJ1276	Single dose of DWJ1276
Rosuvastatin+Olmesartan	Olmetec	single dose of Rosuvastatin 20mg and olmesartan medoxomil(CS-866) 40mg

Primary Outcome Measures

Name	Time	Method
AUClast	18 time points up to 72 hours
Cmax	18 time points up to 72 hours

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Yonsei University Health System (Yuhs); 🇰🇷 Seoul, Korea, Republic of