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)
- Conditions
- Healthy volunteers
- Registration Number
- DRKS00012706
- Lead Sponsor
- HEALTH – Institute for Biomedicine and Health Sciences, JOANNEUM RESEARCH Ges.mbH,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 6
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.
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.
Tattoos or broken and/or damaged skin at the application areas.
Active skin diseases like psoriasis or atopic dermatitis.
Not willing to avoid excessive sun exposure, steam baths, sauna, swimming and other strenuous activities between Visit 2 and the End-of-Study examination
Not willing to refrain from shaving the anterior of the thighs or using skin care products on the anterior of the thighs for at least 5 days prior to start of Visit 2.
Pronounced hairiness on the thighs that may negatively affect BE testing.
Known allergy/hypersensitivity to any of the materials/supplies used during the study.
Presence of needle phobia.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method idocaine/ prilocaine concentration-time curves for the ISF samples obtained from the test sites dosed with three different doses of EMLA® cream.<br>Area under the lidocaine/ prilocaine concentration-time curve from 0-24 hours (AUC0-24) for the ISF samples obtained from the test sites dosed with EMLA® cream.<br>Maximum observed lidocaine/prilocaine concentration (Cmax) in the ISF samples obtained from the test sites dosed with EMLA® cream.<br>Time to reach maximum lidocaine/prilocaine concentration (TMAX) in the ISF samples obtained from the test sites dosed with EMLA® cream.
- Secondary Outcome Measures
Name Time Method idocaine/ prilocaine concentration-time curves for the ISF samples obtained from the test sites dosed with of EMLA® cream, with ORAQIX® gel and with no product application. Lidocaine/ prilocaine concentration-time curves for the blood samples.<br>Area under the lidocaine/ prilocaine concentration-time curve from 0-24 hours (AUC0-24) for the ISF samples obtained from the test sites dosed with EMLA® cream, with ORAQIX® gel and with no product application.<br>Maximum observed lidocaine/prilocaine concentration (Cmax) in the ISF samples obtained from the test sites dosed with EMLA® cream, with ORAQIX® gel and with no product application.<br>Time to reach maximum lidocaine/prilocaine concentration (TMAX) in the ISF samples obtained from the test sites dosed with EMLA® cream, with ORAQIX® gel and with no product application.<br>Factors influence skin penetration (e.g. TEWL, impedance).<br>Inflammation marker and immune cell content