drugset / Trial / NCT01365624

Safety and Pharmacokinetics Study of Intranasal Ketorolac in Elderly and Nonelderly Adult Healthy Subjects

NCT01365624

Phase 1 Completed 30 enrolled American Regent, Inc.
NaSingle-groupOpen-labelTreatment

Summary

This study had an open-label, single-dose design. All subjects received a single dose of 30 mg of intranasal ketorolac. Blood samples for determination of ketorolac plasma levels were obtained pre-dose and at specified time points over 24 hours post-dose. The primary objective of this trial was to compare the pharmacokinetics of intranasal ketorolac between elderly and nonelderly adult subjects. The secondary objective was to evaluate the safety profile of intranasal ketorolac in elderly subjects.

Timeline

Start
2008-02
Primary completion
2008-04
Completion
2008-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Ketorolac Other / unclassified 30 mg Intranasal

Indications

No indication recorded.