Comparing tablets & injections of Keppra in Japanese volunteers; ver 1

• Research type

  Research Study

• Full title

  A single site, open-label, randomized, single-dose, two-way cross-over study in healthy Japanese subjects to evaluate the bioequivalence, safety & tolerability of Levetiracetam administered as an oral tablet or intravenous infusion. (HMR code: 11-006)

• IRAS ID

  79682

• Sponsor organisation

  UCB Pharma SA

• Eudract number

  2011-000827-34

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  Keppra (levetiracetam) is a prescription medicine widely used by doctors to treat epilepsy. People with epilepsy suffer from seizures (fits). Epileptic seizures happen when extra 'messages' get sent to the wrong parts of the brain. Keppra is thought to interfere with those extra messages. Taking Keppra tablets twice daily can prevent epileptic seizures. If patients miss a dose, they might have a seizure. There are times when patients can??t take Keppra by mouth, so they need to have Keppra by injection.Keppra tablets and injections are approved for use in many countries, but only tablets are approved in Japan. Before injections can be approved in Japan, we need to compare the tablet and injection of Keppra in Japanese people.We'll give up to 52 healthy Japanese people, aged 20??55 years, 2 single doses of Keppra. Participants will take tablets in one study session, and receive Keppra by slow injection into a vein in another study session. We'll compare the side effects and blood levels. Participants will take up to 6 weeks to finish the study. They'll stay on the ward for 3 nights in each study session.A pharmaceutical company (UCB Pharma SA) is funding the study.The study will take place at 1 centre in London. We'll recruit healthy participants by: advertising (newspaper, radio, and websites); by word of mouth; from volunteer databases; and via our websites.

• REC name

  Scotland A REC

• REC reference

  11/IE/0063

• Date of REC Opinion

  23 May 2011

• REC opinion

  Further Information Favourable Opinion