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Safety and Pharmacokinetics of Kovacaine Nasal Spray in Pediatric Subjects

NCT01952990 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2015-06-08

No results posted yet for this study

Summary

The purpose of this study is to determine the pharmacokinetics and safety of a nasal spray containing the anesthetic drug Tetracaine in combination with Oxymetazoline in healthy pediatric subjects.

Conditions

  • Anesthesia

Interventions

DRUG

Tetracaine HCl 3% and Oxymetazoline HCl 0.05%

1 spray device is 0.2mL (200 μL) in volume and contains 6mg Tetracaine HCl 3% and 0.1mg Oxymetazoline HCl. Subjects receiving the 100 μL dose will receive half of the contents of one device using a dose divider. Subjects receiving the 200 μL dose will first receive half of the contents of one device using a dose divider and then 4 minutes later will receive the 2nd half by removing the dose divider. Subjects receiving the 400 μL dose will first receive the entire contents of one device and then 4 minutes later will receive the contents of a 2nd device.

Sponsors & Collaborators

  • Triligent International

    collaborator INDUSTRY

  • Analytical Bio-Chemistry Laboratories, Inc.

    collaborator INDUSTRY

  • Rho, Inc.

    collaborator INDUSTRY

  • St. Renatus, LLC

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
3 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2013-10-31
Completion
2013-10-31

Countries

  • United States

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 NCT01952990 on ClinicalTrials.gov