Comparison of PK and Bioequivalence of Epistatus® and Hypnovel®

• Research type

  Research Study

• Full title

  A single-dose, randomised, open-label, four-period, two-sequence crossover study to compare the pharmacokinetic profiles and assess bioequivalence of Epistatus (midazolam oromucosal solution 10 mg/ml) and Hypnovel (midazolam parenteral solution 5 mg/ml) administered via the oromucosal route in healthy adult subjects

• IRAS ID

  126633

• Contact name

  Jorg Taubel

• Sponsor organisation

  Special Products Ltd.

• Eudract number

  2013-000736-10

• ISRCTN Number

  N/A

• Research summary

  This is a follow-on study of a previous study we completed recently. The previous study had a very similar design to compare the pharmacokinetics (absorption and breakdown in the body), safety and tolerability of Epistatus© (an unlicensed midazolam oromucosal solution) and Hypnovel© (a licensed midazolam solution for injection) after a single dose has been administered to 24 volunteers via the Buccal route i.e. between the cheek and gum. The main difference in this study is that we will dose 54 volunteers and double the crossover study periods in order to show formal bioequivalence (the levels of midazolam in the blood) which will help the manufacturers of Epistatus© obtain a license. Volunteers will attend our clinical unit for 4 residential visits (periods) of 3 study days for each period with a washout period of 7 days between each 2 periods. The study will be carried out using a 4-way crossover, open-label, randomised design so the volunteers are randomly allocated to receive either Epistatus© or Hypnovel© during each period; and both the doctor administrating the medication and the volunteer will know whether they receive Hypnovel© or Epistatus©. Volunteers will be involved in the study for up to 68 days including the screening time, and the follow-up at the end of the study. The current drugs on the market such as Diazepam are given as suppositories which is not ideal, particularly as the patient will be having a fit during administration. Epistatus© (midazolam) oromucosal solution is administered by the less invasive and more practical oromucosal route (squirted between the cheek and gum with an oral syringe) so has become more popular for the emergency treatment of seizures and buccal midazolam is already licensed for use in children. The study is sponsored by Special Products Ltd., who manufacture Epistatus© (midazolam) oromucosal solution.

• REC name

  South Central - Berkshire B Research Ethics Committee

• REC reference

  13/SC/0112

• Date of REC Opinion

  27 Mar 2013

• REC opinion

  Further Information Favourable Opinion