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

The purpose of this study is to evaluate the safety and pharmacokinetic characteristics of combination of rosuvastatin and CS-866 and DWJ1276 alone.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: Cresto; Drug: Olmetec; Drug: DWJ1276

• Study Type: Interventional
• Enrollment (Actual): 58
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Yonsei University Health System (Yuhs)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Rosuvastatin+Olmesartan; single dose of Rosuvastatin 20mg and olmesartan medoxomil(CS-866) 40mg	Drug: Cresto; tablet, rosuvastatin 20mg; Drug: Olmetec; tablet, olmesartan medoxomil(CS-866) 40mg
Experimental: DWJ1276; Single dose of DWJ1276	Drug: DWJ1276; tablet, Rosuvastatin 20mg and olmesartan medoxomil 40mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
AUClast	18 time points up to 72 hours
Cmax	18 time points up to 72 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Daewoong Pharmaceutical Co. LTD.
• Investigators: Principal Investigator: Kyungsoo Park, M.D., Ph.D., Yonsei University Health System (Yuhs)

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Actual): February 1, 2012
• Study Completion (Actual): March 1, 2012

Study Registration Dates

• First Submitted: December 13, 2011
• First Submitted That Met QC Criteria: December 14, 2011
• First Posted (Estimate): December 16, 2011

Study Record Updates

• Last Update Posted (Estimate): April 4, 2012
• Last Update Submitted That Met QC Criteria: April 2, 2012
• Last Verified: April 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists; Olmesartan Medoxomil
• Other Study ID Numbers: DW_DWJ1276002