NCT01363050

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Egalet Ltd · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Ketorolac tromethamine	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.

Timeline

• Start date: 2006-01-01
• Primary completion: 2006-02-01
• Completion: 2006-09-01
• First posted: 2011-06-01
• Last updated: 2017-03-16
• Results posted: 2013-05-03

Locations

1 site across 1 country: United Kingdom