Anesthesia Clinical Trial
Official title:
A Single-Center, Study Evaluating The Pharmacokinetics Of Tetracaine, Para-Butylaminobenzoic Acid, And Oxymetazoline After Intranasal Administration Of Kovacaine Mist To Healthy Pediatric Subjects
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.
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 recommended, weight-based Phase 3 dose of Kovacaine Mist (Tetracaine Hydrochloride with
Oxymetazoline Hydrochloride) to healthy pediatric subjects.
Kovacaine Mist is an anesthetic solution containing 3% tetracaine hydrochloride and 0.05%
oxymetazoline hydrochloride. A single spray dose of 100 μL Kovacaine Mist contains 3 mg
tetracaine HCl and 0.05 mg oxymetazoline HCl. A two-100 μL spray dose (a total of 200 μL) of
Kovacaine Mist contains 6 mg tetracaine HCl and 0.1 mg oxymetazoline HCl. A two-200 μL spray
dose (a total of 400 μL) of Kovacaine Mist contains 12 mg tetracaine HCl and 0.2 mg
oxymetazoline HCl.
Kovacaine Mist will be administered based on the weight of the subject as summarized in the
table below. Subjects weighing 10 to <20 kg will receive 1 intranasal spray of 100 μL of
Kovacaine Mist at time D0. Subjects weighing 20 to <40 kg will receive 2 intranasal sprays
of 100 μL (total dose 200 μL) administered 4 minutes apart at times D0 and D4. Subjects
weighing 40 kg or more will receive 2 intranasal sprays of 200 μL (total dose 400 μL)
administered 4 minutes apart at times D0 and D4.
;
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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