Topical AnesthesiaPhase 1NCT03441841
Pharmacokinetic Study of Nanoencapsulated Gel of Lidocaine, Prilocaine and Combination of Lidocaine and Prilocaine
A Phase 1 study testing Lidocaine + Prilocaine, Lidocaine and Prilocaine in people with Topical Anesthesia, run by Galeno Desenvolvimento de Pesquisas Clínicas at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 53 yearsHealthy volunteers can take part
- Conditions the study is for
- Topical Anesthesia
- What is being tested?
- Lidocaine + Prilocaine, Lidocaine and Prilocaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteBrazil
- Study dates
- 28 Feb 2016to 6 May 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 53 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Galeno Desenvolvimento de Pesquisas Clinicas Ltda. - ME
Campinas, São Paulo
About this study
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.
Read the detailed description
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).
- Conditions
- Topical Anesthesia
- Being tested
- Lidocaine + Prilocaine, Lidocaine, Prilocaine
- Keywords
- local anesthetics, pharmacokinetics, nanotechnology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine + PrilocaineDrug
Also called Nanorap®
Single topical dose of 2g lidocaine + prilocaine 2.5 % formulation.
LidocaineDrug
Single topical dose of 2g lidocaine 2.5 % formulation.
PrilocaineDrug
Single topical dose of 2g prilocaine 2.5 % formulation.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Drug: Prilocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 0-24 h
Secondary outcomes (1)
Number of adverse events per participant
Determination of the number of adverse events, in each treatment group, including clinically relevant alterations of vital signs and laboratory tests results.
Measured: Up to 36 h after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2018
- Study start28 Feb 2016
- Primary completion19 Mar 2016
- Study completion6 May 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Topical AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Galeno Desenvolvimento de Pesquisas Clínicas
- Sponsor type
- Other government
- Collaborators
- Biolab Sanus Farmaceutica
- Responsible party
- Principal investigator, Gilberto De Nucci, Galeno Desenvolvimento de Pesquisas Clínicas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03441841
- Sponsor's protocol ID
- GDN 002/16
- Status last verified
- Feb 2018
- First submitted
- 10 Feb 2018
- Last updated
- 22 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03441841
- Acronym / sponsor ID
- GDN 002/16
- Conditions
- Topical Anesthesia
- Keywords
- local anesthetics, pharmacokinetics, nanotechnology
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Galeno Desenvolvimento de Pesquisas ClínicasOther government
- Collaborators
- Biolab Sanus Farmaceutica
- Study start
- 28 Feb 2016 (actual)
- Primary completion
- 19 Mar 2016 (actual)
- Study completion
- 6 May 2016 (actual)
- First posted
- 22 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Lidocaine + prilocaine | Experimental | Drug: Lidocaine + PrilocaineSingle 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. |
| Lidocaine | Active comparator | Drug: LidocaineSingle topical dose of lidocaine nanoencapsulated gel (2.5 %) formulation in a delimited area of 16 cm2 in the volar surface of the forearm. |
| Prilocaine | Active comparator | Drug: PrilocaineSingle topical dose of prilocaine (2.5 %) nanoencapsulated gel formulation in a delimited area of 16 cm2 in the volar surface of the forearm. |
Who may qualify
- Ages
- 19 to 53 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lidocaine + PrilocaineAlso: Nanorap®Single topical dose of 2g lidocaine + prilocaine 2.5 % formulation. | Drug | Lidocaine + prilocaine |
| LidocaineSingle topical dose of 2g lidocaine 2.5 % formulation. | Drug | Lidocaine |
| PrilocaineSingle topical dose of 2g prilocaine 2.5 % formulation. | Drug | Prilocaine |
Primary outcome
Measurement of lidocaine and prilocaine plasma levels
Time frame: 0-24 h
Blood sampling for the determination of plasma levels of lidocaine and prilocaine in participants of each treatment group.
Maximum Plasma Concentration (Cmax) of lidocaine and prilocaine
Time frame: 0-24 h
Determination of Cmax for lidocaine and prilocaine based on plasma concentrations of samples obtained.
Area Under the Curve (AUC) of lidocaine and prilocaine
Time frame: 0-24 h
Determination of AUC for lidocaine and prilocaine based on plasma concentrations of samples obtained.
1 secondary outcome
Number of adverse events per participant
Time frame: Up to 36 h after treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Lidocaine + Prilocaine, Lidocaine and Prilocaine in people with Topical Anesthesia, run by Galeno Desenvolvimento de Pesquisas Clínicas at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of lidocaine and prilocaine plasma levels (time frame: 0-24 h). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2018; AzTrials last refreshed its copy on 8 Nov 2026.