A Single-Center, Study Evaluating The Pharmacokinetics Of Tetracaine, Para-Butylaminobenzoic Acid, And Oxymetazoline After Intranasal Administration Of Kovacaine Mist To Healthy Pediatric Subjects

NCT01952990 Phase 2 COMPLETED

The purpose of this study is to determine the pharmacokinetics and safety of a nasal spray containing the anesthetic drug Tetracaine in combination with Oxymetazoline in healthy pediatric subjects.

Details

Lead sponsor	St. Renatus, LLC
Phase	Phase 2
Status	COMPLETED
Enrolment	18
Start date	2013-09
Completion	2013-10

Conditions

• Anesthesia

Interventions

• Tetracaine HCl 3% and Oxymetazoline HCl 0.05%

Primary outcomes

• Peak Plasma Concentration (Cmax) of tetracaine — 0, 10, 30 minutes, and 1, 3, 6, 8, 9, 12, and 24 hours after completion of the last nasal spray
• Time to Peak Plasma Concentration (Cmax) of tetracaine — 0, 10, 30 minutes, and 1, 3, 6, 8, 9, 12, and 24 hours after completion of the last nasal spray
• Terminal elimination rate constant (λz) of tetracaine — 0, 10, 30 minutes, and 1, 3, 6, 8, 9, 12, and 24 hours after completion of the last nasal spray
• Elimination half-life (t½) of tetracaine — 0, 10, 30 minutes, and 1, 3, 6, 8, 9, 12, and 24 hours after completion of the last nasal spray
• Area under the plasma concentration versus time curve (AUC) of tetracaine — 0, 10, 30 minutes, and 1, 3, 6, 8, 9, 12, and 24 hours after completion of the last nasal spray
• Peak Plasma Concentration (Cmax) of para- butylaminobenzoic acid (PBBA) — 0, 10, 30 minutes, and 1, 3, 6, 8, 9, 12, and 24 hours after completion of the last nasal spray

Countries

United States