A Pharmacokinetic Study Comparing Diclofenac Dosage Forms

• Research type

  Research Study

• Full title

  A Pharmacokinetic Study Comparing the Plasma Concentrations of Diclofenac among Topical Panadol ClearFlex, Topical Voltarol Emulgel and Oral Diclofenac Tablets

• IRAS ID

  81847

• Sponsor organisation

  GlaxoSmithKline Consumer Healthcare

• Eudract number

  2011-002075-42

• Research summary

  Diclofenac is a non-steroidal anti-inflammatory drug (NSAID) used to treat mild to moderate pain and inflammation. In order to reduce the systemic side effects associated with oral diclofenac, Panadol ClearFlex (a new spray on patch) is being developed for local application that targets delivery of diclofenac to the site of tissue damage. This study will compare this new treatment with currently marketed diclofenac products (Voltarol Emulgel applied four times a day and Oral Diclofenac Sodium taken three times a day). Panadol ClearFlex will be tested after twice-daily and three times a day application. A total of 16 male and/or female volunteers (aged 18-50 years) will take part in this study. Volunteers will be randomized to receive 3 out of the 4 possible treatments, with each administered for 3 days. Treatments will be separated by a 7-day washout period.

• REC name

  Scotland A REC

• REC reference

  11/IE/0079

• Date of REC Opinion

  23 Aug 2011

• REC opinion

  Further Information Favourable Opinion