Journal of Bioequivalence & Bioavailability

Esapharma SPA, Via Alcide De Gasperi 13, I-20066 Melzo, Italy

Publications

• Research Article   
  Bioequivalence Study of a Novel Clobetasol Propionate Topical gel 0.05% using the Vasoconstriction Bioassay
  Author(s): Catherine Queille-Roussel, Francesca Morano, Andrea F D Di Stefano*, Paola Babbi and Massimiliano Perego
  
  Background: A novel propylene glycol-based gel containing Clobetasol propionate 0.05% was developed. Methods: This phase I single center, randomized, reference-controlled, human skin vasoconstriction assay study was subdivided into 2 parts with the aim of comparing the skin blanching effect of the new Clobetasol gel versus a marketed reference cream to test their in vivo bioequivalence in compliance with FDA guidance. The pilot part determined the dose-duration response curve to the reference. The pivotal part was the pharmacodynamics in vivo bioequivalence study. Healthy volunteers received single applications on randomized sites of the forearms. In the pilot part, the reference was applied once at 8 dose durations from 0.25 to 6 h to determine the dose duration (D) at which effect is half-maximal (ED50.. View more»
  

  DOI: 10.35248/0975-0851.22.S7.003

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