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

• Sponsor: Daewoong Pharmaceutical Co. LTD. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01493856
• Collaborator: (none)
• Enrollment: 58
• Location: 1
• Arms: 2
• Duration (Months): 2
• Patients Per Site Per Month: 29.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteers	Drug: Cresto; Drug: Olmetec; Drug: DWJ1276	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 58 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Official Title: 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
• Study Start Date: Jan 1, 2012
• Actual Primary Completion Date: Feb 1, 2012
• Actual Study Completion Date: Mar 1, 2012

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. AUClast [18 time points up to 72 hours]

2. Cmax [18 time points up to 72 hours]

Secondary Outcome Measures

1. AUCinf [18 time points up to 72 hours]

2. T1/2 [18 time points up to 72 hours]

3. %AUCextra [18 time points up to 72 hours]

4. Tmax [18 time points up to 72 hours]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 50 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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

1. A subject who had participated in any other clinical study within the last 2 weeks

2. A subject from whom over 400mL of blood was sampled(whole blood donation) within last 2 weeks or plasma/platelet donation within 1 month.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Yonsei University Health System (Yuhs)	Seoul		Korea, Republic of

Sponsors and Collaborators

• Daewoong Pharmaceutical Co. LTD.

Investigators

• Principal Investigator: Kyungsoo Park, M.D., Ph.D., YONSEI UNIVERSITY HEALTH SYSTEM (YUHS)

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Daewoong Pharmaceutical Co. LTD.
• ClinicalTrials.gov Identifier: NCT01493856
• Other Study ID Numbers: DW_DWJ1276002
• First Posted: Dec 16, 2011
• Last Update Posted: Apr 4, 2012
• Last Verified: Apr 1, 2012

• Additional relevant MeSH terms: Olmesartan Medoxomil

Study Results

No Results Posted as of Apr 4, 2012