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

NCT03441841 | Completed Phase 1 DMC

• 1 other identifier: GDN 002/16
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

local anesthetics; pharmacokinetics; nanotechnology

Outcome Measures

Primary Outcomes (3)

• Measurement of lidocaine and prilocaine plasma levels

  Blood sampling for the determination of plasma levels of lidocaine and prilocaine in participants of each treatment group.

  0-24 h

• Maximum Plasma Concentration (Cmax) of lidocaine and prilocaine

  Determination of Cmax for lidocaine and prilocaine based on plasma concentrations of samples obtained.

  0-24 h

• Area Under the Curve (AUC) of lidocaine and prilocaine

  Determination of AUC for lidocaine and prilocaine based on plasma concentrations of samples obtained.

  0-24 h

Secondary Outcomes (1)

• Number of adverse events per participant

  Up to 36 h after treatment

Study Arms (3)

Lidocaine + prilocaine

EXPERIMENTAL

Single topical dose of a combination of nanoencapsulated lidocaine (2.5%) and prilocaine (2.5%) formulation in a delimited area of 16 cm2 in the volar surface of the forearm.

Drug: Lidocaine + Prilocaine

Lidocaine

ACTIVE COMPARATOR

Single topical dose of lidocaine nanoencapsulated gel (2.5 %) formulation in a delimited area of 16 cm2 in the volar surface of the forearm.

Drug: Lidocaine

Prilocaine

ACTIVE COMPARATOR

Single topical dose of prilocaine (2.5 %) nanoencapsulated gel formulation in a delimited area of 16 cm2 in the volar surface of the forearm.

Drug: Prilocaine

Interventions

Lidocaine + Prilocaine DRUG

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

Also known as: Nanorap®

Lidocaine + prilocaine

Lidocaine DRUG

Single topical dose of 2g lidocaine 2.5 % formulation.

Lidocaine

Prilocaine DRUG

Single topical dose of 2g prilocaine 2.5 % formulation.

Prilocaine

Eligibility Criteria

• Age: 19 Years - 53 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy volunteers over 18 years old
• Body mass index (BMI) ≥ 19.0 kg/m² and ≤ 28.75 kg/m²
• No evidence of significant diseases, that, at the investigator's discretion, may affect the participation in the clinical trial, in accordance with the protocol requirements
• Ability to understand the nature and the objective of the clinical trial,including the risks and possible side effects; intention to cooperate with the investigator and act in accordance with the protocol requirements, as confirmed by the informed consent form signature.

You may not qualify if:

• Subjects with known hypersensitivity to the compounds of the investigational products, severe allergies or multiple drug allergies
• Existing diseases or pathological findings, which might interfere with the safety or tolerability, and/or pharmacokinetics of the drug
• Screening laboratory tests presenting deviations deemed as clinically significant, which, due to possible risks, prevents the participation in clinical trial.
• Use of maintenance therapy with any drug
• Drug or alcohol dependence
• Volunteers who ingests more than 5 cups of coffee or tea per day and/or smoke
• Volunteers with unusual eating habits, e.g, vegetarian
• Treatment, within 3 months prior to the initiation of the clinical trial treatment, with any drug known to have a well-established toxic potential to major organs.
• Use of regular medication within 2 weeks before the start of treatment and the date of evaluation, or made use of any medication within one week, except for oral contraceptives or cases where, based on the half-life of the drug and/or active metabolites, complete elimination can be assumed
• Treatment within 6 months prior to the study with any known drug of have a well-defined toxic potential in large organs
• Hospitalization for any reason up to 8 weeks before the start of the treatment of this study
• Participation in a clinical trial during the last 6 months
• Blood donation or other blood loss of more than 450 mL within the last 3 months
• Pregnant, delivery or abortion in the 12 weeks prior to the planned hospitalization
• The volunteer who has any condition that prevents him from participating in the study by judgment of the investigator

Sponsors & Collaborators

• Galeno Desenvolvimento de Pesquisas Clínicas: lead
• Biolab Sanus Farmaceutica: collaborator

Study Sites (1)

Galeno Desenvolvimento de Pesquisas Clinicas Ltda. - ME

Campinas, São Paulo, Brazil

Location

MeSH Terms

Interventions

Lidocaine, Prilocaine Drug Combination; Lidocaine; Prilocaine

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Drug Combinations; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: February 10, 2018
• First Posted: February 22, 2018
• Study Start: February 28, 2016
• Primary Completion: March 19, 2016
• Study Completion: May 6, 2016
• Last Updated: February 22, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)