Safety and Pharmacokinetics of Kovacaine Nasal Spray in Pediatric Subjects

PHASE2CompletedINTERVENTIONAL
Enrollment

18

Participants

Timeline

Start Date

September 30, 2013

Primary Completion Date

October 31, 2013

Study Completion Date

October 31, 2013

Conditions
Anesthesia
Interventions
DRUG

Tetracaine HCl 3% and Oxymetazoline HCl 0.05%

1 spray device is 0.2mL (200 μL) in volume and contains 6mg Tetracaine HCl 3% and 0.1mg Oxymetazoline HCl. Subjects receiving the 100 μL dose will receive half of the contents of one device using a dose divider. Subjects receiving the 200 μL dose will first receive half of the contents of one device using a dose divider and then 4 minutes later will receive the 2nd half by removing the dose divider. Subjects receiving the 400 μL dose will first receive the entire contents of one device and then 4 minutes later will receive the contents of a 2nd device.

Trial Locations (1)

90036

AXIS Clinical Trials Research Center, Los Angeles

All Listed Sponsors
collaborator

Triligent International

INDUSTRY

collaborator

Analytical Bio-Chemistry Laboratories, Inc.

INDUSTRY

collaborator

Rho, Inc.

INDUSTRY

lead

St. Renatus, LLC

INDUSTRY

NCT01952990 - Safety and Pharmacokinetics of Kovacaine Nasal Spray in Pediatric Subjects | Biotech Hunter | Biotech Hunter