Pharmacokinetics, Safety, and Tolerability Study of GOPRELTO® Nasal Solution and NUMBRINO™ Nasal Solution

Conditions

• ENT Disorder
• Nasal Anesthesia
• Nasal Mucosa Surgery
• Nasal Procedures

Eligibility Criteria

Sex

ALL

Age

12 Years - 18 Years

Healthy Volunteers

Not accepted

Interventions

• Cocaine Hydrochloride Nasal Solution — DRUG
  Topical Anesthetic
• Cocaine Hydrochloride Nasal Solution — DRUG
  Topical Anesthetic

Study Details

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.

Key Dates

Start date

Dec 6, 2025

Status verified

Dec 2025

Primary completion

Dec 31, 2027

Completion

Dec 31, 2027

Study Design

Enrollment

40 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

PREVENTION

Arms

• Experimental: GOPRELTO® nasal solution, 4%,
  FDA Approved GOPRELTO® (cocaine hydrochloride nasal solution, 4%); Up to 160 mg depending on subject's weight; Saturated cottonoid pledgets are applied topically in both nostrils by study personnel
• Experimental: NUMBRINO™ nasal solution, 4%
  FDA Approved NUMBRINO™ (cocaine hydrochloride nasal solution, 4%); Up to 160 mg depending on subject's weight; Saturated cottonoid pledgets are applied topically in both nostrils by study personnel

Primary Outcome Measure

Changes in Blood pressure [ Time Frame: Baseline and every 5 minutes through 90 minutes post-pledget application. ]

Central Contacts

• Robert Puchlaski, M.D
  803-256-7076; 803-549-2467
  [email protected]

Locations (4)

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