Comparison of Lu AA21004 tablets and liquid; ver 1

• Research type

  Research Study

• Full title

  A Single Dose, Open-Label, Randomised, Two-Way Crossover Bioequivalence Study of Lu AA21004 in healthy subjects comparing 20 mg of an Oral Drops Solution (Test) with a 20 mg Tablet (Reference)

• IRAS ID

  86911

• Contact name

  Steve Warrington

• Sponsor organisation

  H. Lundbeck A/S

• Eudract number

  2011-002852-14

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  Lu AA21004 is a new experimental medicine for treating depression and anxiety. Medicines for depression and anxiety have many side effects, and often don't work well. We hope that Lu AA21004 will work better and have fewer side effects than existing medicines. This study compares blood levels and side effects of two formulations of Lu AA21004, A and B. We'll also take blood samples for ??biomarker?? research ?? that's the study of substances that may be linked to depression and anxiety or to the way the body handles and responds to the study medicine. Biomarker research will include tests on DNA (pieces of genes).26 healthy men and women, aged 18??55 years, will take part. They??ll have 2 study sessions. In one session, they??ll take a dose of study medicine as formulation A, in the other session, they??ll take it as formulation B. A computer will decide the order in which participants take the two formulations.Participants will take up to 9« weeks to finish the study: they??ll make 2 outpatient visits and have 2 inpatient stays (8 nights in total).The study will take place at 1 centre in London. We'll recruit participants by advertising (newspaper, radio, and websites), word of mouth, from volunteer databases, and our website.A pharmaceutical company, H. Lundbeck A/S, is paying for the study.

• REC name

  South Central - Berkshire B Research Ethics Committee

• REC reference

  11/IE/0106

• Date of REC Opinion

  5 Sep 2011

• REC opinion

  Further Information Favourable Opinion