Healthy Clinical Trial
Official title:
An Exploratory Study in Healthy Volunteers to Identify Factors Influencing Bioequivalence Studies on Moderately Lipophilic Drugs Using Dermal Open Flow Microperfusion (dOFM)
The overall aim of this clinical study is to develop a general bioequivalence (BE) testing method using dermal open flow microperfusion (dOFM) for dermatological drug products. In this study BE of different lidocaine/prilocaine products will be assessed and factors that influence dOFM data variability will be evaluated.
The study will involve 20 healthy adult participants. Dermal pharmacokinetic (PK) profile of
three different lidocaine/prilocaine products will be assessed in parallel at different skin
sites on the same participant.
For BE evaluations a reference product will be compared against itself and an approved
generic test product as positive control and against a non-equivalent test product as
negative control. Additionally different non-invasive measurements (e.g. TEWL) will be
conducted and results will be correlated with lidocaine/prilocaine PK data to identify
factors that might influence skin penetration.
dOFM probes will be inserted into the dermis to monitor the dermal drug concentrations up to
12 h post-dose in topically treated skin sites. Blood samples will be drawn to rule out
systemic appearance of lidocaine and/or prilocaine.
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