Investigation of Pharmacokinetic Interaction Between Rosuvastatin and Olmesartan in Healthy Male Volunteers
Phase 1
Completed
- Conditions
- Healthy
- Interventions
- Registration Number
- NCT01831479
- Lead Sponsor
- Severance Hospital
- Brief Summary
This study investigates pharmacokinetics and drug-drug interaction between Rosuvastatin and Olmesartan in healthy male volunteers
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 36
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Rosuvastatin and Olmesartan 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 Rosuvastatin and Olmesartan Rosuvastatin 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 Rosuvastatin and Olmesartan 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
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Severance Hospital
🇰🇷Seoul, Korea, Republic of