Evaluate the Ability of dOFM for BE Testing of Topically Applied Diclofenac Sodium Products in Healthy Subjects
Condition: Healthy
Study type: Interventional

Summary: 
      This will be a single center, open label, exploratory research study to assess the dermal
      pharmacokinetic (PK) profile of three marketed diclofenac products in 26 healthy volunteers
      using dermal open flow microperfusion (dOFM).

      This clinical study aims to assess bioequivalence (BE) of three different diclofenac
      products.
    

Detailed description: 
      The clinical study is divided into a pilot and a pivotal study. The pilot study will involve
      6 healthy adult volunteers. The pilot study aims to develop the optimal study design for the
      pivotal study by defining the dose of the reference product (diclofenac sodium gel 1%) and by
      evaluating the absence of significant systemic cross-talk (systemic redistribution) and
      lateral diffusion (cross-talk between adjacent treatment sites), which could increase
      background drug levels in the dermis that might confound the discrimination of dermal PK
      profiles between different products. Additionally, the suitability of a non-equivalent test
      product to serve as negative control for BE relative to the reference product will be
      evaluated.

      The pivotal study will involve 20 healthy adult volunteers. In each volunteer the dermal PK
      profile of three different diclofenac products will be assessed in 6 topical treatment sites
      using dermal open flow microperfusion (dOFM), where the diclofenac penetration will be
      measured from baseline to 12 h post-dose. BE of the reference product against a generic test
      product (positive control) and against a non-equivalent test product (negative control) will
      be evaluated.
    

Intervention name(s): Voltaren - Diclofenac sodium gel 1% (GSK, USA); Pennsaid 2 % Topical Solution (Horizon Therapeutics, USA); Diclofenac sodium gel 1% (Perrigo, USA); Dermal open flow microperfusion - Pilot; Dermal open flow microperfusion - Pivotal; Blood sampling - Pilot; Blood sampling - Pivotal
Intervention type(s): Drug; Drug; Drug; Device; Device; Procedure; Procedure
Intervention description(s): Topical application in dermal-sampling visit; Topical application in dermal-sampling visit; Topical application in dermal-sampling visit; Dermal open flow microperfusion will be used to collect interstitial fluid in order to assess diclofenac concentration in the dermis. Interstitial fluid (ISF) sampling: 1 hour pre-dose and 24 hours post-dose.; Dermal open flow microperfusion will be used to collect interstitial fluid in order to assess diclofenac concentration in the dermis. Interstitial fluid (ISF) sampling: 1 hour pre-dose and 12 hours post-dose.; 1 sample is taken pre-dose and 24 samples are taken post-dose.; 1 sample is taken pre-dose and 12 samples are taken post-dose.
Intervention MeSH terms: Diclofenac; Coal Tar
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Bioequivalence; Dermal open flow microperfusion; Dermal Pharmacokinetics Measurement