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Safety and Pharmacokinetics of Kovacaine Nasal Spray (24 Hour Blood Collection)

NCT01807624 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2017-08-30

Study results available
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Summary

The purpose of this study is to determine the pharmacokinetics/pharmacodynamics and safety of a nasal spray containing the anesthetic drug tetracaine in combination with oxymetazoline with blood draws over 24 hours.

Conditions

  • Anesthesia

Interventions

DRUG

Tetracaine HCl 3% and Oxymetazoline HCl 0.05%

1 spray is 0.2mL is volume and contains 6mg Tetracaine HCl 3% and 0.1mg Oxymetazoline HCl (para-butylaminobenzoic acid or PABA is active metabolite)

Sponsors & Collaborators

  • Triligent International

    collaborator INDUSTRY

  • Rho, Inc.

    collaborator INDUSTRY

  • Analytical Bio-Chemistry Laboratories, Inc.

    collaborator INDUSTRY

  • St. Renatus, LLC

    lead INDUSTRY

Principal Investigators

  • Jim Mulvahill · St. Renatus

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2013-03-31
Primary Completion
2013-03-31
Completion
2013-03-31

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 NCT01807624 on ClinicalTrials.gov