NCT01356212

Assessment of Nasal Deposition and Clearance of Ketorolac Solution Administered Using the Valois Nasal Spray Device

Scintigraphic Assessment of Nasal Deposition and Clearance of 99mTc DTPA Ketorolac Solution Administered Using the Valois Nasal Spray Device

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Egalet Ltd · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This was a randomised three-way crossover design study. The study consisted of three study periods each separated by a minimum 44 hour washout period. During the course of each study period, scintigraphic images were acquired at planned intervals after dosing. Subjects were able to leave the clinical unit after the completion of study specific procedures at 6 hours post-dose. The primary objective of the study was to determine whether any of the radiolabelled ketorolac formulation was deposited in the lungs of healthy volunteers following nasal inhalation under three different conditions (gentle sniff-inhalation with subject standing, vigorous sniff-inhalation with subject standing, gentle sniff-inhalation with subject semi-supine). The secondary objectives were to determine the deposition pattern of radiolabelled ketorolac solution in the nasal cavity, and clearance of the radiolabel over a six-hour period.

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DRUG	Ketorolac tromethamine	30 mg ketorolac (15 mg (100 ul) per nostril) administered intranasally
DRUG	Ketorolac tromethamine	30 mg ketorolac (15 mg (100 ul) per nostril) administered intranasally
DRUG	Ketorolac tromethamine	30 mg ketorolac (15 mg (100 ul) per nostril) administered intranasally

Timeline

• Start date: 2002-09-01
• Primary completion: 2002-10-01
• Completion: 2002-12-01
• First posted: 2011-05-19
• Last updated: 2017-02-08

Locations

1 site across 1 country: United Kingdom