Investigation of Pharmacokinetic Interaction Between Rosuvastatin and Olmesartan in Healthy Male Volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01831479

Enrollment

Registered

2013-04-15

Start date

2011-08-31

Completion date

2011-10-31

Last updated

2013-04-15

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

Conditions

Healthy

Keywords

Pharmacokinetics, drug-drug interaction

Brief summary

This study investigates pharmacokinetics and drug-drug interaction between Rosuvastatin and Olmesartan in healthy male volunteers

Interventions

DRUGRosuvastatin

Single administration of rosuvastatin 20mg tablet QD for 7 consecutive days

DRUGOlmesartan

Single administration of olmesartan 40mg tablet QD for 7 consecutive days

DRUGRosuvastatin and olmesartan

Co-administration of rosuvastatin 20mg tablet and and olmesartan 40mg tablet QD for 7 consecutive days

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

20 Years to 50 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy male volunteers between the ages of 20 and 50 and within 20% of their ideal body weight, without congenital abnormality or chronic disease

Exclusion criteria

* History of cardiovascular, pulmonary, renal, endogenous, gastrointestinal, hematologic, neurologic or hemorrhagic disease; * Clinically significant findings on routine laboratory (hematology, serum chemistry and urinalysis) or ECG tests; * Use of prescription drugs in the 14 days immediately prior to starting the study that had the potential to interact with the study medication; * Use of any substance that could induce or inhibit drug metabolism enzymes

Design outcomes

Primary

Measure	Time frame	Description
Profile of Pharmacokinetics	0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72 hours post-dose with a sample at 72 hr being taken for rosuvastatin only	Css,max, AUCtau

Secondary

Measure	Time frame	Description
Profile of Pharmacokinetics	0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72 hours post-dose with a sample at 72 hr being taken for rosuvastatin only	AUCss,last, AUCss,inf, Css,min, T\_1/2

Countries

South Korea

Outcome results

None listed

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