(duplicate) Vasoconstrictor Assay for Clobetasone Butyrate (PH-GB-001)

• Research type

  Research Study

• Full title

  A Study To Investigate The Bioequivalence Of Eumovate® Ointment And A Generic Form Of Clobetasone Butyrate 0.05% w/w Ointment Using The Vasoconstrictor Response On Healthy Human Skin

• IRAS ID

  65615

• Contact name

  Ronald marks

• Sponsor organisation

  PharmaServe R&D Ltd

• Eudract number

  2010-022800-38

• ISRCTN Number

  1

• Research summary

  The study is designed to investigate the bioequivalence of a generic form of clobetasone butyrate 0.05% w/w ointment compared to Eumovate ointment using the FDA vasoconstriction protocol and in accordance with EMEA guidelines. The test is divided into a pilot phase, where the dose duration is determined, and a pivotal phase, where the bioequivalence is determined.

• REC name

  Wales REC 1

• REC reference

  10/WSE04/56

• Date of REC Opinion

  13 Jan 2011

• REC opinion

  Further Information Favourable Opinion