Study of the Tolerability of Ketorolac Tromethamine Following Intranasal Administration in Healthy Volunteers
Status:
Completed
Trial end date:
2007-06-01
Target enrollment:
Participant gender:
Summary
This was a Phase 1, double blind, two part study in healthy male and female volunteers. Each
subject participated in only one part of the study. In Part A subjects received one dose of
15 mg ketorolac tromethamine with a lidocaine hydrochloride free formulation in one nostril
and one dose of 15 mg ketorolac tromethamine containing 6% lidocaine hydrochloride in the
other nostril, in a randomized manner. In Part B subjects were randomized to receive a single
intranasal dose of 15 mg ketorolac tromethamine containing 0% lidocaine hydrochloride into
one nostril and either placebo or a single intranasal dose of 15 mg ketorolac tromethamine
containing 0%, 4% or 6% lidocaine hydrochloride into the other nostril. During the study,
subjects remained resident from the morning of Day 1 until the afternoon of Day 1, when a
post-study medical was performed prior to discharge.
The objective of this study was to compare the tolerability of formulations of ketorolac
tromethamine with differing concentrations of lidocaine hydrochloride (0% and 6% in Part A
and 0%, 4%, 6% and placebo in Part B) following intranasal administration to healthy
volunteers.