Topical Anesthesia Clinical Trial
Official title:
A Cross-over Study of Pharmacokinetic Interaction Comparing Nanoencapsulated Gel of Prilocaine (2.5%), Lidocaine (2.5%) and Association of Prilocaine + Lidocaine 2.5% (Nanorap®) Topically in Healthy Volunteers.
This trial evaluated the pharmacokinetic interaction between fixed doses of lidocaine (2.5%), prilocaine (2.5%) or the association of both (Nanorap®) in healthy volunteers. The drug safety and tolerability was also evaluated.
This study was performed as a monocentric, open, randomized, double-blind, with 3 treatment
regimen (lidocaine, prilocaine, or Nanorap®) in 3 periods design. Volunteers were submitted
to clinical and laboratory examination before enrollment. Treatments were carried out on 3
different days with a washout period of 7 days between each dose.
After a fasting period (8 h), volunteers received topically 2g of the formulation in a
delimited area of 16 cm2 in the volar surface of the forearm. The product was applied to the
left arm and venous blood was collected from the right arm. The remaining product was removed
with a cotton swab 10 minutes after application. Blood samples (3.5 mL) were collected into
heparinized tubes before (0:00) and at 1.0, 2.0, 3.0, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 7.5,
8.0, 8.5, 9.0, 9.5, 10.0, 10.5, 11.0, 12.0, 14.0, 16.0 and 24.0 h after the hydrogel
application.
Blood samples were centrifuged at 2000 g (4 ⁰C) for 10 minutes and the obtained plasma
samples were stored at -20 °C until analysis.
Following dosing, volunteers were monitored for 36 h in a clinical setting safety and
tolerability (signs, symptoms, adverse events, and laboratory parameters). The vital signs
(blood pressure and pulse rate) were evaluated. ECGs were obtained before (30 min) and at
drug Cmax (6 h) for each product application. QT interval corrected by heart rate (QTc) data
were obtained from a Bionet Cardiocare 2000 and BMS-Plus software program, using Bazett's
formula: QTc = QT/(sqrt RR Interval).
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02507440 -
Impact of Topical Pharyngeal Anesthetics on Discharge of the Patients When Used in Conjunction With Propofol Sedation in Routine EGD's
|
Phase 4 |