Lugoff

Researchers are studying the pharmacokinetic (PK) properties, safety, and tolerability of GOPRELTO4 and NUMBRINO12 nasal solutions, which are anesthetic drugs used for diagnostic procedures and surgeries involving the mucous membranes of the nasal cavities. These products are already approved for adults, and this study focuses on pediatric adolescent subjects aged 12 to under 18 years to better understand appropriate dosing and effects in this age group. The study is an open-label, phase 3 trial aiming to evaluate both anesthetics when used as a single topical dose for local anesthesia. Participants will receive one single dose of either GOPRELTO4 or NUMBRINO12 nasal solution applied as a pledget to the nasal mucous membranes. The study monitors the pharmacokinetics by measuring drug concentrations in plasma at multiple time points up to 8 hours after application. Safety and tolerability are also assessed during this period. This administration occurs on Treatment Day 1, with a screening visit beforehand to confirm eligibility and baseline measurements. During the study, participants undergo physical examinations, electrocardiograms, pulse oximetry, and continuous monitoring of vital signs such as blood pressure, heart rate, and respiratory rate at various intervals before and after pledget application. Researchers track adverse events from Treatment Day 1 through a follow-up call on Day 10. The study measures key outcomes including maximum plasma concentration, time to maximum concentration, and drug elimination parameters to understand how the drugs behave in pediatric subjects.