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

NCT ID: NCT01831479

Last Updated: 2013-04-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-08-31
• Study Completion Date: 2011-10-31

Brief Summary

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

Conditions

Healthy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Rosuvastatin and Olmesartan

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

Group Type: EXPERIMENTAL

Rosuvastatin

Intervention Type: DRUG

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

Olmesartan

Intervention Type: DRUG

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

Rosuvastatin and olmesartan

Intervention Type: DRUG

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

Interventions

Rosuvastatin

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

Intervention Type: DRUG

Olmesartan

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

Intervention Type: DRUG

Rosuvastatin and olmesartan

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Severance Hospital

OTHER

Sponsor Role: lead

Responsible Party

Kyungsoo Park

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Severance Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

DWJ1276001

Identifier Type: -

Identifier Source: org_study_id