Cholesterol
Conditions
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.
Interventions
DRUGezetimibe
ezetimibe 20 mg (2 x 10 mg tablets) on Days 1 through Day 7.
DRUGComparator: cyclosporine
single oral dose of cyclosporine 100 mg capsules on Day 1 or Day 7.
Sponsors
Schering-Plough
Organon and Co
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. |
Outcome results
None listed