A 2 way crossover study of Clobazam vs Frisium Tablets in adults

• Research type

  Research Study

• Full title

  An open label, randomised, two-period, two-treatment, two sequence, single dose, two-way crossover, bioequivalence study comparing Clobazam 10mg/5ml Oral Suspension with Frisium 10mg Tablets in healthy, adult, male and female subjects under fasting conditions

• IRAS ID

  222136

• Contact name

  Annelize Koch

• Contact email

  annelize.koch@simbecorion.com

• Sponsor organisation

  Wockhardt UK Ltd

• Eudract number

  2017-000046-21

• Duration of Study in the UK

  0 years, 5 months, 1 days

• Research summary

  This study is being funded by Wockhardt. A pharmaceutical company based in the UK, who specialise in generic products.

  The purpose of this study is to compare 2 different types (formulations) of Clobazam. To help compare the 2 products, blood samples will be taken at specific times during the study after subjects have taken one of clobazam formulations. Measuring drug levels in blood will help to find out how much clobazam has been absorbed into the blood stream from the stomach/gastro-intestinal tract.

  Twenty-four (24) subjects are to be enrolled. Some of the most important entry criteria are:

  - Subjects (male and females) are aged between 18 and 60 and are considered healthy
  - Subjects are not taking any medication
  - Subjects are a non-smoker or ex-smoker who hasn't smoked in the last 3 months

  The study will consist of a screening visit, 2 treatment visits (there will be a 28-day washout between treatment visits), and one post study follow-up visit. Each treatment visit will include 2 overnight stay and two additional return visits. The post study follow-up will take place 7-10 days after the final blood draw of treatment period 2.

• REC name

  Wales REC 1

• REC reference

  17/WA/0018

• Date of REC Opinion

  20 Feb 2017

• REC opinion

  Further Information Favourable Opinion