At a glance
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A Phase 1, Double-blind, 4-way Crossover Study of the Tolerability, Safety and Pharmacokinetics of 4 Formulations of Ketorolac Tromethamine by Intranasal Administration in Healthy Volunteers
In Brief
A Phase 1 clinical trial evaluating Ketorolac Tromethamine, Ketorolac Tromethamine with 4% Lidocaine hydrochloride (HCl), and 2 other interventions for Healthy Volunteers. Completed, enrolled 16 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
30 mg Ketorolac Tromethamine intranasal (IN)
30 mg Ketorolac Tromethamine with 4% Lidocaine HCl IN
30 mg Ketorolac Tromethamine with 5% Lidocaine HCl IN
30 mg Ketorolac Tromethamine with 6% Lidocaine HCl IN