Study of the Relative Oral Bioavailability of the Antiflu Medicine Oseltamivir in the Intensive Care Unit
Status:
Withdrawn
Trial end date:
2009-07-01
Target enrollment:
Participant gender:
Summary
This proposed pharmacokinetic study will test the hypothesis that in critically ill patients
with respiratory failure requiring mechanical ventilation such as might be anticipated to be
needed to treat patients with severe influenza pneumonia, oseltamivir administered enterally
via nasogastric tube, with and without concomitant food or alimentation, will have similar
oral bioavailability to that observed in ambulatory adults ill with influenza in whom
oseltamivir therapy 75 mg BID is efficacious and well tolerated. Additionally, this
experiment will test the hypothesis that increasing the dose (150 mg), with and without
concomitant enteral feeding, will show a proportionate increase in bioavailability. Relative
oral bioavailability will be assessed from plasma concentration vs. time over 12 hrs and
urinary recovery of drug from 0 to 48 hrs after administration.