Pharmacokinetics and Drug Interaction Study Between Amlodipine,Olmesartan and Rosuvastatin in Healthy Adult Volunteers

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02089399

Enrollment

Registered

2014-03-17

Start date

2014-05-31

Completion date

2014-06-30

Last updated

2015-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

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.

Interventions

DRUGSevikar(amlodipne/olmesartan)

Treatment AB

DRUGcrestor(Rosuvastatin)

Treatment AB/Treatment C

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

19 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
AUCtau	Multiple blood sample will be collected for 24 hours after last dosing in each of the treatment
Css,max	Multiple blood sample will be collected for 24 hours after last dosing in each of the treatment

Secondary

Measure	Time frame
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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026