NCT01365611

Open Label Study to Assess the Pharmacokinetics of Intranasal Ketorolac Tromethamine Following Fluticasone Propionate in Healthy Subjects

Open Label Study to Assess the Pharmacokinetics of Intranasal Ketorolac Tromethamine Following Multiple Doses of Fluticasone Propionate in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Egalet Ltd · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

This was a non-randomized, open label study in healthy male and female volunteers. A single intranasal dose of 30 mg ketorolac tromethamine was administered to all subjects on Days 1 and 6; in addition, subjects received a daily intranasal dose of 200 µg fluticasone propionate on Days 2-6. Subjects remained resident in the Clinical Unit from the evening of Day 1 until the morning of Day 2 and from the evening of Day 5 until the morning of Day 7, and made ambulatory visits to the Clinical Unit on the morning of Days 3-5. A post study medical was performed within 7 days of study completion. The objective of this study was to assess the effects of chronic administration of fluticasone propionate on the pharmacokinetics of intranasal ketorolac in healthy male and female subjects.

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DRUG	Ketorolac tromethamine	A single intranasal dose of 30 mg ketorolac tromethamine was administered to all subjects on Days 1 and 6.
DRUG	Fluticasone Propionate	Daily intranasal dose of 200 ug fluticasone propionate on Days 2-6

Timeline

• Start date: 2007-02-01
• Primary completion: 2007-05-01
• Completion: 2008-03-01
• First posted: 2011-06-03
• Last updated: 2017-03-15
• Results posted: 2013-04-30

Locations

1 site across 1 country: United Kingdom