Assessment of Nasal Deposition and Clearance of Ketorolac Solution Administered Using the Valois Nasal Spray Device
Status:
Completed
Trial end date:
2002-12-01
Target enrollment:
Participant gender:
Summary
This was a randomised three-way crossover design study. The study consisted of three study
periods each separated by a minimum 44 hour washout period. During the course of each study
period, scintigraphic images were acquired at planned intervals after dosing. Subjects were
able to leave the clinical unit after the completion of study specific procedures at 6 hours
post-dose.
The primary objective of the study was to determine whether any of the radiolabelled
ketorolac formulation was deposited in the lungs of healthy volunteers following nasal
inhalation under three different conditions (gentle sniff-inhalation with subject standing,
vigorous sniff-inhalation with subject standing, gentle sniff-inhalation with subject
semi-supine). The secondary objectives were to determine the deposition pattern of
radiolabelled ketorolac solution in the nasal cavity, and clearance of the radiolabel over a
six-hour period.