Tolerability, Safety and Pharmacokinetics of Four Formulations of Ketorolac Tromethamine in Healthy Volunteers
Status:
Completed
Trial end date:
2006-03-01
Target enrollment:
Participant gender:
Summary
This was a phase 1, double-blind, 4-way crossover study in healthy male and female
volunteers. Subjects received 4 formulations of intranasal ketorolac tromethamine 30 mg.
There was a wash-out period of 3-7 days between each dose. On Day 1 of each period subjects
were randomised to receive either a single intranasal dose of 30 mg ketorolac tromethamine
alone or single intranasal dose of 30 mg ketorolac tromethamine with 4%, 5% or 6% lidocaine
hydrochloride. At the end of the study each subject had received all 4 treatments.
The primary objective of this study in healthy volunteers was to compare the safety,
tolerability, and pharmacokinetics of 4 formulations of ketorolac tromethamine. A secondary
objective was to monitor lidocaine hydrochloride plasma levels.