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The Pharmacokinetics Of Tetracaine, Para-Butylaminobenzoic Acid, And Oxymetazoline After Intranasal Administration Of The Highest Phase 3 Dose Of Kovacaine™ Mist To Healthy Volunteers
The purpose of this study is to determine the pharmacokinetics/pharmacodynamics and safety of a nasal spray containing the anesthetic drug tetracaine in combination with oxymetazoline with blood draws over 24 hours.
Details
| Lead sponsor | St. Renatus, LLC |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 24 |
| Start date | 2013-03 |
| Completion | 2013-03 |
Conditions
- Anesthesia
Interventions
- Tetracaine HCl 3% and Oxymetazoline HCl 0.05%
Primary outcomes
- Cmax of Oxymetazoline and PBBA — 0, 5, 10, 15, 20, 25, 30, 40, 50 minutes, and 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12, 16 and 24 hours after completion of the last nasal spray
- Tmax of Oxymetazoline and PBBA — 0, 5, 10, 15, 20, 25, 30, 40, 50 minutes, and 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12, 16 and 24 hours after completion of the last nasal spray
- Half-life of Oxymetazoline and PBBA — 0, 5, 10, 15, 20, 25, 30, 40, 50 minutes, and 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12, 16 and 24 hours after completion of the last nasal spray
- AUC0-t of Oxymetazoline and PBBA — 0, 5, 10, 15, 20, 25, 30, 40, 50 minutes, and 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12, 16 and 24 hours after completion of the last nasal spray
- AUC0-infinity of Oxymetazoline and PBBA — 0, 5, 10, 15, 20, 25, 30, 40, 50 minutes, and 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12, 16 and 24 hours after completion of the last nasal spray
Countries
United States