Bioavailability Study Comparing Tolvaptan Administered Via Nasogastric Tube to Tolvaptan Tablets Swallowed Intact
Status:
Completed
Trial end date:
2012-02-01
Target enrollment:
Participant gender:
Summary
The purpose of the study is to compare the relative bioavailability and pharmacokinetics of
tolvaptan 15 mg tablets administered orally versus tolvaptan via nasogastric (NG) tube in
healthy male and female subjects.
This study is an open 2-treatment, 2-period, 2-sequence crossover study to compare the
relative bioavailability of tolvaptan tablets to tolvaptan given via nasogastric tube in 28
healthy adults. Subjects will be randomized to one of the two treatment sequences; either
tolvaptan oral tablets swallowed intact followed by a tablet crushed and administered via
nasogastric tube, or the reverse sequence. Serial pharmacokinetic samples will be collected
following each tolvaptan administration and safety assessments will be performed. The
relative bioavailability of tolvaptan administered via nasogastric tube will be compared to
tolvaptan tablets swallowed intact.