CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 15 enrolled
Drug / intervention
Ketorolac tromethaminedrug
Likely dose
Ketorolac tromethamine 30 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01363050
NCT01363050Phase 1Completed
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A Phase 1, Open Label, Multiple Dose Study to Determine the Tolerability, Safety and Pharmacokinetics of Ketorolac Tromethamine by Intranasal Administration in Healthy Volunteers

Egalet Ltd·interventional·Posted Jun 1, 2011·Updated Mar 16, 2017

In Brief

A Phase 1 clinical trial evaluating Ketorolac tromethamine for Healthy Volunteers. Completed, enrolled 15 participants across 1 site.

Detailed Summary

This was a phase 1, open label, multiple dose study in healthy male and female volunteers. Subjects received intranasal ketorolac tromethamine (30 mg) three times daily (t.i.d.) for three days (seven doses in total). Doses were administered every eight hours. The objective of this study in healthy volunteers was to determine the safety, tolerability, and pharmacokinetics of multiple doses of intranasal ketorolac tromethamine.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy Volunteers
CountriesUnited Kingdom
Collaborators--

Timeline

Phase 1CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 1, 2011
Enrollment StartJan 1, 2006
Primary CompletionFeb 1, 2006
Study CompletionSep 1, 2006
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 15.1 years ago

Interventions

Ketorolac tromethaminedrug

Subjects received intranasal ketorolac tromethamine (30 mg) three times daily (t.i.d.) for three days (seven doses in total). Doses were administered every eight hours.