NCT01355588

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Egalet Ltd · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Ketorolac Tromethamine	30 mg Ketorolac Tromethamine intranasal (IN)
DRUG	Ketorolac Tromethamine with 4% Lidocaine hydrochloride (HCl)	30 mg Ketorolac Tromethamine with 4% Lidocaine HCl IN
DRUG	Ketorolac Tromethamine with 5% Lidocaine HCl	30 mg Ketorolac Tromethamine with 5% Lidocaine HCl IN
DRUG	30 mg Ketorolac Tromethamine with 6% Lidocaine HCl	30 mg Ketorolac Tromethamine with 6% Lidocaine HCl IN

Timeline

• Start date: 2005-08-01
• Primary completion: 2005-09-01
• Completion: 2006-03-01
• First posted: 2011-05-18
• Last updated: 2017-03-16
• Results posted: 2013-05-03

Locations

1 site across 1 country: United Kingdom