A crossover study to compare the PK of Epistatus® with Hypnovel®

• Research type

  Research Study

• Full title

  A single-dose, randomised, open-label, two-period, two-treatment, healthy volunteer, crossover study to compare the pharmacokinetic profiles of Epistatus® (midazolam oromucosal solution 10 mg/ml) with the marketed formulation Hypnovel® (5 mg/ml parenteral solution) via the oromucosal route

• IRAS ID

  106419

• Contact name

  Jorg Taubel

• Sponsor organisation

  Special Products Ltd.

• Eudract number

  2012-001785-15

• Research summary

  We are conducting a clinical trial, with a marketed but unlicensed medication called Epistatus© (midazolam) oromucosal solution used for treatment of epileptic seizures (fits). We want to find out more information about the absorption of Epistatus© (midazolam) oromucosal solution into the body, in comparison to Hypnovel© (midazolam) solution for injection, after a single dose has been administered to volunteers via the Buccal route. Hypnovel© is a licensed medicine which also contains the active ingredient midazolam and will be used as a comparator. The study is designed for up to 24 healthy volunteers to enroll and complete the study. Volunteers will attend our clinical unit for 2 residential visits (periods) over 3 days which is the main part of the study; but volunteers will be involved in the study for up to 53 days including the time when we determine who is suitable for taking part in the study, and the follow-up at the end of the study. The study will be carried out using a crossover, open-label, randomised design which means the volunteers who are randomly allocated to receive Epistatin© during Period 1 will receive Hypnovel during Period 2 and vice-versa; and both the doctor administrating the medication and the volunteer will know whether they receive Hypnovel© or Epistatus©. The current drugs on the market such as Diazepam are given by 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 gums and teeth with an oral syringe) so it is expected to become more popular for the emergency treatment of seizures if it is equally or more effective. The study is sponsored by Special Products Ltd., who manufacture Epistatus© (midazolam) oromucosal solution.

• REC name

  London - London Bridge Research Ethics Committee

• REC reference

  12/LO/0694

• Date of REC Opinion

  6 Jun 2012

• REC opinion

  Further Information Favourable Opinion