Pharmacokinetics and Drug Interaction Study Between Rosuvastatin and CS-866 in Healthy Male Volunteers

NCT01415466 | Completed Phase 1

• 1 other identifier: DW_DWJ1276001
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the pharmacokinetics profile and drug-drug interaction between rosuvastatin and CS-866 in healthy male volunteers.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• AUCtau

  Multiple blood samples will be collected for 72 hours after last dosing in each of the periods.((in case of CS-866, for 48 hours)

• Css,max

  Multiple blood samples will be collected for 72 hours after last dosing in each of the periods.(in case of CS-866, for 48 hours)

Secondary Outcomes (4)

• AUCss,last

  Multiple blood samples will be collected for 72 hours after last dosing in each of the periods. (in case of CS-866, for 48 hours)

• AUCss,inf

  Multiple blood samples will be collected for 72 hours after last dosing in each of the periods. (in case of CS-866, for 48 hours)

• Css,min

  Multiple blood samples will be collected for 72 hours after last dosing in each of the periods. (in case of CS-866, for 48 hours)

• T1/2

  Multiple blood samples will be collected for 72 hours after last dosing in each of the periods. (in case of CS-866, for 48 hours)

Study Arms (3)

R

EXPERIMENTAL

multiple dose of Rosuvastatin 20mg

Drug: Cresto

O

EXPERIMENTAL

multiple dose of CS-866 40mg

Drug: Olmetec

R+O

EXPERIMENTAL

multiple dose of the combination of Rosuvastatin 20mg and CS-866 40mg

Drug: Cresto, Olmetec

Interventions

Cresto DRUG

tablet, 20mg

R

Olmetec DRUG

tablet, 40mg

O

Cresto, Olmetec DRUG

tablet, 20mg and 40mg

R+O

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Daewoong Pharmaceutical Co. LTD.: lead
• Yonsei University: collaborator

Study Sites (1)

Yonsei University Health System (Yuhs)

Seoul, South Korea

Location

MeSH Terms

Interventions

Olmesartan Medoxomil

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Tetrazoles

Study Officials

• Kyungsoo Park, M.D., Ph.D.

  YONSEI UNIVERSITY HEALTH SYSTEM (YUHS)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2011
• First Posted: August 12, 2011
• Study Start: August 1, 2011
• Primary Completion: September 1, 2011
• Study Completion: October 1, 2011
• Last Updated: April 4, 2012

Record last verified: 2012-04

Locations

KR (1)