Pharmacokinetics, Safety, and Tolerability of GOPRELTO and NUMBRINO in Pediatric Nasal Procedures
Status:
NOT_YET_RECRUITING
Trial end date:
2026-12-25
Target enrollment:
Participant gender:
Summary
This open-label, two-arm, single-dose clinical study evaluates the pharmacokinetics, safety, and tolerability of GOPRELTO (cocaine hydrochloride nasal solution 4%) and NUMBRINO (cocaine hydrochloride nasal solution 4%) in pediatric subjects aged 12 to \<18 years undergoing diagnostic procedures or surgeries on or through the nasal mucous membranes. Up to 20 subjects will receive GOPRELTO and up to 20 will receive NUMBRINO.