Phase 1Completed
Tolerability, Safety and Pharmacokinetics of Four Formulations of Ketorolac Tromethamine in Healthy Volunteers
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
- Sponsor
- Egalet Ltd (Industry)
- Enrollment
- 16 enrolled
- Conditions
- Healthy Volunteers
- Interventions
- Ketorolac Tromethamine; Ketorolac Tromethamine with 4% Lidocaine hydrochloride (HCl); Ketorolac Tromethamine with 5% Lidocaine HCl; 30 mg Ketorolac Tromethamine with 6% Lidocaine HCl
- Ages
- adults
- Registry
- NCT01355588
Full record on ClinicalTrials.gov
From the registry
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.
Primary outcomes
- Maximum Observed Plasma Concentration (Cmax)
- Area Under the Plasma Concentration-time Profile From Time Zero to the Last Quantifiable Post-dose (AUC 0-t)
- Area Under the Plasma Concentration-time Profile From Time Zero to Infinity (AUC 0-∞)
History
Last registry update
Results first posted
Registered
Study completion
Primary completion
Started