Conditions: Healthy Volunteers
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 16
Healthy volunteers: yes

Brief 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.

Detailed description:

Arms:
arm 1: None arm 2: None arm 3: None arm 4: None

Interventions: intervention 1: Ketorolac Tromethamine intervention 2: Ketorolac Tromethamine with 4% Lidocaine hydrochloride (HCl) intervention 3: Ketorolac Tromethamine with 5% Lidocaine HCl intervention 4: 30 mg Ketorolac Tromethamine with 6% Lidocaine HCl
Intervention descriptions: intervention 1: 30 mg Ketorolac Tromethamine intranasal (IN) intervention 2: 30 mg Ketorolac Tromethamine with 4% Lidocaine HCl IN intervention 3: 30 mg Ketorolac Tromethamine with 5% Lidocaine HCl IN intervention 4: 30 mg Ketorolac Tromethamine with 6% Lidocaine HCl IN

Protocol document: