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Tolerability, Safety and Pharmacokinetics of Four Formulations of Ketorolac Tromethamine in Healthy Volunteers

NCT01355588 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2017-03-16

Study results available
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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

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

Sponsors & Collaborators

  • Egalet Ltd

    lead INDUSTRY

Principal Investigators

  • Cyril Clarke, BSc MB BS MFPM · Medeval Limited

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-08-31
Primary Completion
2005-09-30
Completion
2006-03-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01355588 on ClinicalTrials.gov