ENT Disorder Clinical Trial
Official title:
Open-label, Pharmacokinetics, Safety, and Tolerability Study of a Single Topical Dose of GOPRELTO® Nasal Solution for the Induction of Local Anesthesia in Pediatric Subjects From ≥12 Years to <17 Years of Age
The purpose of this study is to assess the pharmacokinetic (PK) properties, safety, tolerability, and dosing of GOPRELTO® as an anesthetic for diagnostic procedures and surgeries on or through the mucous membranes of the nasal cavities in pediatric adolescent subjects.
GOPRELTO® (cocaine hydrochloride nasal solution, 4%) is an approved product in adults. The purpose of this study is to assess the pharmacokinetic (PK) properties, safety, tolerability, and dosing of GOPRELTO® as an anesthetic for diagnostic procedures and surgeries on or through the mucous membranes of the nasal cavities in pediatric adolescent subjects. The primary objectives of the study are: - To assess the safety and tolerability of GOPRELTO® nasal solution in pediatric adolescent subjects as an anesthetic for diagnostic procedures and surgeries on or through the mucous membranes of the nasal cavities. - To evaluate the PK properties and define the dosing for GOPRELTO® nasal solution in pediatric adolescent subjects as an anesthetic for diagnostic procedures and surgeries on or through the mucous membranes of the nasal cavities. ;
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