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

Healthy Volunteers Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01493856
• Other study ID #: DW_DWJ1276002
• Status: Completed
• Phase: Phase 1
• First received: December 13, 2011
• Last updated: April 2, 2012
• Start date: January 2012
• Est. completion date: March 2012

Study information

• Verified date: April 2012
• Source: Daewoong Pharmaceutical Co. LTD.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: March 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 50 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Cresto
tablet, rosuvastatin 20mg
• Olmetec
tablet, olmesartan medoxomil(CS-866) 40mg
• DWJ1276
tablet, Rosuvastatin 20mg and olmesartan medoxomil 40mg

Locations

Country	Name	City	State
Korea, Republic of	Yonsei University Health System (Yuhs)	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Daewoong Pharmaceutical Co. LTD.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUClast		18 time points up to 72 hours	No
Primary	Cmax		18 time points up to 72 hours	No
Secondary	AUCinf		18 time points up to 72 hours	No
Secondary	T1/2		18 time points up to 72 hours	No
Secondary	%AUCextra		18 time points up to 72 hours	No
Secondary	Tmax		18 time points up to 72 hours	No