A STUDY COMPARING SUBLINGUAL TABLETS WITH INTRAVENOUS ALFENTANIL V1

• Research type

  Research Study

• Full title

  A Randomised, Single Dose, Open Label, Four-way Crossover Study to Assess the Pharmacokinetics of Two Different Sublingual Alfentanil Tablet Formulations Relative to Intravenous Alfentanil

• IRAS ID

  64952

• Contact name

  Simon Singer

• Sponsor organisation

  Orexo AB

• Eudract number

  2010-022981-28

• Research summary

  This study aims to investigate a new formulation of Alfentanil. Orexo have developed 2 different types of tablets (OX51-1 and OX51-2), containing Alfentanil to be given to dissolve under the tongue. This is a single centre, open label, randomized 4 way crossover study. Each subject will participate in a screening visit, one study period in which 4 doses will be administered and a follow up visit. Subjects will be randomised to receive 3 doses of one of the two sublingual formulations and an IV formulation. The two formulations will be compared by measurement of pharmacokinetic parameters up to 24hours after each dose. Assessment of taste and sedation will be measured. Vital signs will be measured throughout and adverse events monitored for the duration of the study. The effect of Alfentanil will be measured via pupillometry. Subjects must be male or female, aged between 18 and 45 years inclusive with a Body Mass Index of 19.0 to 29.0 inclusive. They must also be negative for alcohol and drugs of abuse tests at screening and on admission, have refrained from smoking within two weeks of screening visit until the completion of the study and be in good health in the opinion of the investigator.

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  10/IEC03/21

• Date of REC Opinion

  15 Nov 2010

• REC opinion

  Further Information Favourable Opinion