CompletedNot Applicable

An Exploratory Pilot Study in Healthy Volunteers to Assess the Parameters for the Design of Bioequivalence Studies on Moderately Lipophilic, Moderately to Highly Protein Bound Drugs Using Dermal Open Flow Microperfusion (dOFM)

Austria6 participantsStarted 2018-03-22

Plain-language summary

The overall aim of this clinical pilot study is to develop an optimal design (e.g. dose, study duration) for the main clinical study. In the main study factors that influence dOFM data variability will be measured to develop a general BE testing method using dOFM for dermatological drug products.

Who can participate

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 18 to 65 years inclusive,
✓. Males and/or non-pregnant, non-breastfeeding females (subjects need to be informed about adequate contraceptive methods).
✓. Able to read, understand, and sign the written informed consent form.
✓. Willing to follow the protocol requirements and comply with protocol restrictions.

Exclusion criteria

✕. Social Habits
✕. Smoker who is not willing to restrain from smoking during the in-house-visit (Visit 2).
✕. History of drug and/or alcohol abuse within one year of start of study as judged by the investigator.
✕. Medications
✕. Diseases
✕. Congenital or idiopathic methemoglobinemia
✕. Glucose-6-phosphate dehydrogenase deficiencies
✕. Presence of any acute or chronic disease or malignancies unless deemed not clinically significant by the investigator.

What they're measuring

Find the dose of Lidocaine 2.5% and Prilocaine 2.5% cream for the main study by comparing the concentration time curves and corresponding PK parameter Cmax of 3 different doses (5 mg/cm², 10 mg/cm² and 15 mg/cm²) twice in each subject

Timeframe: 24 hours

Find the dose of Lidocaine 2.5% and Prilocaine 2.5% cream for the main study by comparing the concentration time curves and corresponding PK parameter AUC of 3 different doses (5 mg/cm², 10 mg/cm² and 15 mg/cm²) twice in each subject

Timeframe: 24 hours

Trial details

NCT IDNCT03613207

SponsorJoanneum Research Forschungsgesellschaft mbH

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-04-10

View on ClinicalTrials.gov More Dermatology/Skin - Other trials

Who can participate

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 18 to 65 years inclusive,
✓. Males and/or non-pregnant, non-breastfeeding females (subjects need to be informed about adequate contraceptive methods).
✓. Able to read, understand, and sign the written informed consent form.
✓. Willing to follow the protocol requirements and comply with protocol restrictions.

Exclusion criteria

✕. Social Habits
✕. Smoker who is not willing to restrain from smoking during the in-house-visit (Visit 2).
✕. History of drug and/or alcohol abuse within one year of start of study as judged by the investigator.
✕. Medications
✕. Diseases
✕. Congenital or idiopathic methemoglobinemia
✕. Glucose-6-phosphate dehydrogenase deficiencies
✕. Presence of any acute or chronic disease or malignancies unless deemed not clinically significant by the investigator.

What they're measuring

Timeframe: 24 hours