Comparison Study of Tablets for Use in Treating Diabetes

• Research type

  Research Study

• Full title

  An Open-Label, Randomized, 2-Cohort, 4-Sequence, 4-Period Crossover Study to Determine the Bioequivalence of Alogliptin 6.25 mg and 12.5 mg and Glucophage® (metformin HCl) 500 mg and 1000 mg when Administered as Individual Tablets and as a Fixed-Dose Combination Tablet

• IRAS ID

  79620

• Contact name

  Stephen Smith

• Sponsor organisation

  Celerion on behalf of Takeda Global Research & Development Centre (Europe) Ltd.

• Eudract number

  2011-001109-29

• Research summary

  Four dose strengths of a new fixed-dose combination (FDC) tablet (containing two active ingredients) will be compared to giving tablets of each ingredient separately. The purpose of the study is to:?½ Compare the amounts of and rates at which the two active ingredients get into and are removed from the bloodstream when given as FDC and separate tablets.?½ Look at the safety of, and the ability of the body to tolerate, the two active ingredients when given as FDC and separate tablets.A total of up to 72 healthy volunteers will take part in this study, split into two groups of equal size, with each group investigating two dose strengths of the FDC and co-administered separate tablets. The maximum length of the study for a volunteer from screening until study completion could be 66 days.

• REC name

  Scotland A REC

• REC reference

  11/IE/0053

• Date of REC Opinion

  24 May 2011

• REC opinion

  Further Information Favourable Opinion