Participants on Warfarin Therapy Clinical Trial
Official title:
An Open-label, Randomized 2-period Crossover Study to Investigate the Pharmacodynamics, Pharmacokinetics, Safety and Tolerability of Warfarin in Combination With Oseltamivir in Volunteers Stabilized on Warfarin Therapy
This is an open-label, randomized, 2-period crossover study, to evaluate the pharmacokinetics, pharmacodynamics, safety and tolerability of warfarin in combination with Tamiflu (oseltamivir) in participants stabilized on warfarin. Participants will be randomized to receive either Treatment A followed by Treatment B (AB) or Treatment B followed by Treatment A (BA) in 2 treatment periods. Treatment A includes participant's usual warfarin therapy, and Treatment B includes warfarin therapy along with repeated doses of oseltamivir twice daily for 4 days, and once on Day 5. The treatment periods will be separated by a washout period of at least 4 days.
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Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label