NCT01807624

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

The Pharmacokinetics Of Tetracaine, Para-Butylaminobenzoic Acid, And Oxymetazoline After Intranasal Administration Of The Highest Phase 3 Dose Of Kovacaine™ Mist To Healthy Volunteers

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: St. Renatus, LLC · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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.

Detailed description

The purpose of this study is to determine the pharmacokinetics and safety of tetracaine, para- butylaminobenzoic acid (PBBA), and oxymetazoline after intranasal administration of the highest Phase 3 dose of Kovacaine Mist (Tetracaine Hydrochloride with Oxymetazoline Hydrochloride) to healthy volunteers. This is an open-label, single-treatment, single-dose study in healthy volunteers in which all subjects will receive the highest Phase 3 dose of Kovacaine Mist on one occasion. No randomization is necessary for this single treatment, single dose study. A single study center will participate. Each subject will receive a single dose of Kovacaine Mist (3% tetracaine HCl with 0.05% oxymetazoline HCl) consisting of 3 sprays (each 0.2 mL) in one nostril not taking longer than 8 minutes, for a total 0.6 mL dose containing 18 mg tetracaine HCl and 0.3 mg oxymetazoline HCl. The total dosing period will be 8 minutes. Subjects will be required to fast 10 hours prior to dosing and for four (4) hours after dosing. Water will be allowed ad lib during the study except for one (1) hour prior through one (1) hour after dose administration. Subjects will be admitted to the study unit no later than 2100 hours of the evening prior to drug administration and will remain in the unit until the 24 hour blood sample is collected and discharge procedures are completed.

Conditions

• Anesthesia

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2013-03-01
• Primary completion: 2013-03-01
• Completion: 2013-03-01
• First posted: 2013-03-08
• Last updated: 2017-08-30
• Results posted: 2016-12-29

Locations

1 site across 1 country: United States