Status:
COMPLETED
An Exploratory Study in Healthy Volunteers to Investigate the Cross-talk Between Local Drug Concentrations in the Skin and Systemic Concentrations During Topical Bioequivalence Studies Using Dermal Sampling Techniques
Lead Sponsor:
Joanneum Research Forschungsgesellschaft mbH
Conditions:
Healthy
Dermal Pharmacokinetic Measurement
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
This will be a single center, open label, exploratory research study to assess the dermal and systemic PK of marketed products of lidocaine/prilocaine in 26 healthy participants using dermal open flow...
Detailed Description
The clinical study is divided into a pilot and a pivotal study. The pilot study will involve 6 healthy adult participants and in each participant the concentration of lidocaine/prilocaine will be ass...
Eligibility Criteria
Inclusion
- Healthy, adult volunteers of age 18 to 65 years (both inclusive).
- Males or non-pregnant, non-breast feeding females using adequate contraceptive methods or abstinence.
- Able to read, understand and sign the written informed consent form.
- Willing to follow the protocol requirements and comply with protocol restrictions.
Exclusion
- Social Habits
- Smoker who is not willing to restrain from smoking during the in-house visits.
- History of drug and/or alcohol abuse within one year of start of study as judged by the investigator.
- Medications
- Current treatment with systemically effective corticosteroids, monoamine oxidase (MAO) inhibitors, systemic non-selective beta-blockers, warfarin or anticholinergic drugs, or use of any medications referred in the prescription information of the products.
- Hormonal contraceptive or hormone replacement therapy, routine vitamins or other prescribed medication are allowed if dose is stable.
- Diseases
- Congenital or idiopathic methemoglobinemia.
- History of deep vein thrombosis (DVT)/pulmonary emboly (PE)
- Inherited blood disorders (such as factor V Leiden) who are prone to hypercoagulable state
- Glucose-6-phosphate dehydrogenase deficiencies
- Presence of any acute or chronic diseases or malignancies unless deemed not clinically significant by the investigator.
- Any reason, which in the opinion of the investigator, would prevent the subject from safely participating in the study.
- Any abnormalities found at physical examination or vital signs, unless deemed not clinically significant by the investigator.
- Clinically significant abnormal laboratory evaluation results, as deemed by the investigator.
- Clinically significant abnormal 12-lead ECG at screening, as deemed by the investigator.
- Positive results to the test for hepatitis B antigen or hepatitis C antibodies.
- Positive HIV test.
- Positive alcohol breath test.
- Blood donation within 30 days or significant loss of blood or plasma (more than 550 ml) within 90 days prior to screening.
- Subject who have received an investigational drug within 30 days prior to the initial dose of study medication.
- Known or suspected allergy/hypersensitivity to lidocaine or prilocaine, known history of sensitivity to local anesthetics of the amide type or to any other component of the product, other related products, or any inactive ingredients.
- Tattoos or broken and/or damaged skin at the application areas.
- Active skin diseases like psoriasis or atopic dermatitis, as judged by the investigator.
- Scarring at the anterior part of the thighs.
- Subjects prone to keloid or hypertrophic scar formation or any known wound healing disorder.
- Recent and/or recurrent history of autonomic dysfunction (e.g., recurrent episodes of fainting, palpitations, etc.), as judged by the investigator.
- Not willing to avoid excessive sun exposure, steam baths, sauna, swimming and other strenuous activities for 14 days after Visit 2 to ensure good tissue regeneration.
- Not willing to refrain from shaving the planned application sites or using skin care products on the planned application sites for at least 5 days prior to start of Visit 2.
- Pronounced hairiness on the planned application sites that may negatively affect BE testing.
- Known allergy/hypersensitivity to any of the materials/supplies used during the study.
- Presence of needle phobia.
Key Trial Info
Start Date :
January 16 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 28 2019
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT03813030
Start Date
January 16 2019
End Date
August 28 2019
Last Update
February 10 2023
Active Locations (1)
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1
Clinical Research Center, Medical University Graz
Graz, Austria, 8010