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Pharmacokinetic Study of Nanoencapsulated Gel of Lidocaine, Prilocaine and Combination of Lidocaine and Prilocaine

NCT03441841 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2018-02-22

No results posted yet for this study

Summary

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.

Conditions

  • Topical Anesthesia

Interventions

DRUG

Lidocaine + Prilocaine

Single topical dose of 2g lidocaine + prilocaine 2.5 % formulation.

DRUG

Lidocaine

Single topical dose of 2g lidocaine 2.5 % formulation.

DRUG

Prilocaine

Single topical dose of 2g prilocaine 2.5 % formulation.

Sponsors & Collaborators

  • Biolab Sanus Farmaceutica

    collaborator INDUSTRY

  • Galeno Desenvolvimento de Pesquisas Clínicas

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
19 Years
Max Age
53 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-02-28
Primary Completion
2016-03-19
Completion
2016-05-06

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03441841 on ClinicalTrials.gov