drugset / Trial / NCT01363050

Study to Determine the Tolerability, Safety and Pharmacokinetics of Ketorolac Tromethamine by Intranasal Administration in Healthy Volunteers

NCT01363050

Phase 1 Completed 15 enrolled Egalet Ltd
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2006-01
Primary completion
2006-02
Completion
2006-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Ketorolac Other / unclassified 30 mg Intranasal

Indications

No indication recorded.