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

NCT01356212 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2017-02-08

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Egalet Ltd

    lead INDUSTRY

Principal Investigators

  • L Rankin, MD · Pharmaceutical Profiles, Ltd

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2002-09-30
Primary Completion
2002-10-31
Completion
2002-12-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01356212 on ClinicalTrials.gov