MD Ezetimibe Cyclosporine Interaction (0653-057)
- Registration Number
- NCT00653276
- Lead Sponsor
- Organon and Co
- Brief Summary
Study to determine the effect of multiple oral doses of ezetimibe on the pharmacokinetics of a single oral dose cyclosporine in young healthy males and females.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 13
Inclusion Criteria
- Subject is male or female between 18 to 45 years of age
- Subject is judged to be in good health on the basis of history, physical examination, and routine laboratory data
Exclusion Criteria
- Premenopausal women who are currently pregnant or who are currently nursing
- Subjects with drug or substance abuse, poor mental function, history of major gastrointestinal abnormalities (stomach issues), or high cholesterol
- Subject that has donated blood or has participated in another clinical trial within the last four weeks
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Treatment B ezetimibe Treatment B: subjects will receive single oral daily doses of ezetimibe 20 mg (2 x 10 mg tablets) on Days 1 through 6, followed by coadministration of a single oral dose of ezetimibe 20 mg (2 x 10 mg tablets) and cyclosporine 100 mg capsule on Day 7.
- Primary Outcome Measures
Name Time Method To evaluate the safety and tolerability of cyclosporine coadministered with ezetimibe vs. cyclosporine administered alone. Blood sampling will be conducted for 48 hours starting with the first cyclosporine dosing.
- Secondary Outcome Measures
Name Time Method