The objective of this study is to compare the pharmacokinetics of lopinavir tablets
administered to pediatric patients as either whole or crushed tablets. The study is a
randomized,open-label, crossover study of pediatric subjects already taking
lopinavir/ritonavir tablets as part of their clinical care. THe investigators hypothesize
that lopinavir exposure in pediatric patients will be lower after taking a dose of the tablet
formulation, crushed and mixed with pudding or yogurt, as compared to the exposure after
taking a dose with tablets swallowed whole.
Phase:
Phase 4
Details
Lead Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)