Status:
COMPLETED
Pharmacokinetic Study of Nanoencapsulated Gel of Lidocaine, Prilocaine and Combination of Lidocaine and Prilocaine
Lead Sponsor:
Galeno Desenvolvimento de Pesquisas Clínicas
Collaborating Sponsors:
Biolab Sanus Farmaceutica
Conditions:
Topical Anesthesia
Eligibility:
All Genders
19-53 years
Phase:
PHASE1
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 tolerab...
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 ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
February 28 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 6 2016
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT03441841
Start Date
February 28 2016
End Date
May 6 2016
Last Update
February 22 2018
Active Locations (1)
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1
Galeno Desenvolvimento de Pesquisas Clinicas Ltda. - ME
Campinas, São Paulo, Brazil