An Open-label, Two-Arm, Pharmacokinetics, Safety, and Tolerability Study of a Single Topical Dose of GOPRELTO® Nasal Solution and a Single Dose of NUMBRINO™ Nasal Solution for the Induction of Local Anesthesia of the Mucous Membranes When Performing Diagnostic Procedures and Surgeries in Pediatric Subjects From ≥12 Years to <18 Years of Age
Noden Pharma
Summary
The purpose of this study is to assess the pharmacokinetic (PK) properties, safety and tolerability following a single dose administration of GOPRELTO® or NUMBRINO™ as an anesthetic for diagnostic procedures and surgeries on or through the mucous membranes of the nasal cavities in pediatric adolescent subjects.
Description
GOPRELTO® and NUMBRINO™ (cocaine hydrochloride nasal solution, 4%) are approved anesthetic products in adults. The purpose of this study is to assess the pharmacokinetic (PK) properties, safety, tolerability, and dosing of GOPRELTO® and NUMBRINO™ each 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 for each treatment of the study are: * To assess the safety and tolerability of GOPRELTO® and NUMBRINO™ nasal solution in pediatric adolescent subjects as an anesthetic for di…
Eligibility
- Age range
- 12–18 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: A subject will be eligible for inclusion in the study if he or she meets all of the following criteria: 1. Is accompanied and/or represented by a parent or guardian able to comprehend and sign the informed consent document. 2. Is able to understand and provide assent to an age-appropriate subject assent form (as defined by local practice or regulation). 3. Subject or parent/guardian is able to communicate with the Investigator and comply with the requirements of the protocol. 4. Is male or female ≥12 to \<18 years of age at the time of dosing. 5. Is no lower than the 10th…
Interventions
- DrugCocaine Hydrochloride Nasal Solution
Topical Anesthetic
- DrugCocaine Hydrochloride Nasal Solution
Topical Anesthetic
Locations (4)
- SCENT Sleep and Allergy, 110 Highland Center DriveColumbia, South Carolina
- SCENT Sleep and Allergy, 145 Park CentralColumbia, South Carolina
- South Carolina ENT, Sleep and AllergyColumbia, South Carolina
- SCENT Sleep and Allergy, 15 Exchange Dr.Lugoff, South Carolina