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

Yonsei University

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Rosuvastatin and olmesartan; Drug: Olmesartan; Drug: Rosuvastatin

Study type: Interventional

Funder types: Other

Identifiers

NCT01831479

DWJ1276001

Details and patient eligibility

About

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

Enrollment: 36 patients

Sex: Male

Ages: 20 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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36 participants in 1 patient group

Rosuvastatin and Olmesartan

Experimental group

Description:

A multiple-dose administration of rosuvastatin, a multiple-dose administration of olmesartan, and a multiple-dose administration of rosuvastatin and olmesartan, given orally with a washout period of 8 days between each administrations

Treatment:

Drug: Olmesartan

Drug: Rosuvastatin

Drug: Rosuvastatin and olmesartan