Single dose study to assess absolute bioavailability of ipragliflozin

• Research type

  Research Study

• Full title

  A single dose, open-label, randomized two-period crossover study in healthy young subjects to assess the absolute bioavailability of ipragliflozin

• IRAS ID

  79372

• Contact name

  Ashley Brooks

• Sponsor organisation

  Astellas Pharma Europe B.V. (APEB)

• Eudract number

  2010-023813-77

• Research summary

  Ipragliflozin is being developed as an oral-tablet formulation for mono-therapy and/or Combination therapy for treatment of type 2 diabetes mellitus (T2DM).This will be a two-period randomized crossover study in which the absolute bioavailability of ipragliflozin will be assessed by using an oral and IV preparation.Subjects will reside in the clinical unit for 2 periods of 5 days (4 nights). There will be a wash-out period of at least 7 days between the dosing occasions. In total 14 healthy male or female subjects (minimal 6 of each gender) will be randomized to ensure 12 evaluable subjects. The subjects will be randomized in such way that in the first period 7 subjects will receive the study medication as an oral (tablet) formulation and 7 as an intravenous (i.v.) formulation. In the second period, the subjects will receive the study medication in the alternate way. Both formulations will be administered under fasted conditions.After discharge on Day 4 of period 2 subjects will return for an end of study visit (ESV) after 7-14 days.

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  11/IE/0075

• Date of REC Opinion

  7 Jun 2011

• REC opinion

  Further Information Favourable Opinion