Safety and bioavailability of multiple doses of GF-001001-00 2% cream.

• Research type

  Research Study

• Full title

  GF-001001-00 2% cream formulation. A phase I, double blind, 2-way crossover, placebo controlled, multiple dose study to examine the systemic bioavailability and safety of topical applications in healthy volunteers

• IRAS ID

  8372

• Sponsor organisation

  Ferrer International

• Eudract number

  2008-004817-82

• ISRCTN Number

  NA

• Research summary

  This is a double blind (neither the subjects nor the researchers know who is receiving the active drug), 2-way crossover, randomized, multiple dose, placebo controlled study. The purpose of this study is to find out how a cream containing a drug code named as GF-001001-00 is absorbed after repeated applications to subjects skin. The study is also to check that the drug is safe and causes subjects no discomfort. Ferrer the sponsor of this study will be responsible for funding this research..

• REC name

  Wales REC 1

• REC reference

  08/WSE04/74

• Date of REC Opinion

  27 Nov 2008

• REC opinion

  Further Information Favourable Opinion