Status:
COMPLETED
MD Ezetimibe Cyclosporine Interaction (0653-057)
Lead Sponsor:
Organon and Co
Collaborating Sponsors:
Schering-Plough
Conditions:
Cholesterol
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2004
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT00653276
Start Date
November 1 2003
End Date
January 1 2004
Last Update
August 15 2024
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