An Open Label, Randomized, 2-Sequence, Multiple-Dose, Cross-Over Study to Investigate the Drug-Drug Interaction of Sevikar and Crestor in Healthy Adult Volunteers

Daewoong Pharmaceutical Co. LTD.1 site in 1 country32 target enrollmentMay 2014

ConditionsHealthy

InterventionsSevikar(amlodipne/olmesartan)crestor(Rosuvastatin)

DrugsSevikar(amlodipne/olmesartan)crestor(Rosuvastatin)

Overview

Phase: Phase 1
Intervention: Sevikar(amlodipne/olmesartan)
Conditions: Healthy
Sponsor: Daewoong Pharmaceutical Co. LTD.
Enrollment: 32
Locations: 1
Primary Endpoint: AUCtau
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to evaluate the pharmacokinetics profile and drug-drug interaction between amlodipine, olmesartan and rosuvastatin in healthy adult volunteers.

Registry

clinicaltrials.gov

Start Date

May 2014

End Date

June 2014

Last Updated

11 years ago

Study Type

Interventional

Study Design

Crossover

Sex

Male

Investigators

Sponsor

Daewoong Pharmaceutical Co. LTD.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Healthy male subjects aged 19 - 55 years
•A body mass index in the range 19 - 27 kg/m2
•Willingness to participate during the entire study period
•Written informed consent after being fully informed about the study procedures

Exclusion Criteria

•Any past medical history of hepatic, renal, gastrointestinal, respiratory, endocrine, psychiatric, neurologic, haemato-oncologic or cardiovascular disease
•History of clinically significant drug hypersensitivity
•Use of medication within 7 days before the first dose
•Heavy drinker (\>140 g/week)
•Whole blood donation during 60 days before the study
•Judged not eligible for study participation by investigator

Arms & Interventions

Treatment AB

S-\>S+C

Intervention: Sevikar(amlodipne/olmesartan)

Treatment AB

S-\>S+C

Intervention: crestor(Rosuvastatin)

Treatment C

Intervention: crestor(Rosuvastatin)

Outcomes

Primary Outcomes

AUCtau

Time Frame: Multiple blood sample will be collected for 24 hours after last dosing in each of the treatment

Css,max

Time Frame: Multiple blood sample will be collected for 24 hours after last dosing in each of the treatment

Secondary Outcomes

Tss,max(Multiple blood sample will be collected for 24 hours after last dosing in each of the treatment)
Css,min(Multiple blood sample will be collected for 24 hours after last dosing in each of the treatment)