A BE study of Dapagliflozin/Metformin tablets in healthy volunteers

• Research type

  Research Study

• Full title

  A Bioequivalence Study of the Fixed Dose Combination Dapagliflozin/Metformin Tablet (0.5 mg/850 mg) Relative to a 5.0 mg Dapagliflozin Tablet and a 850 mg Metformin (Glucophage® Marketed in Canada by Sanofi-Aventis) Tablet Co-Administered to Healthy Subjects in the Fasted and Fed States.

• IRAS ID

  100791

• Contact name

  Alex Wong

• Sponsor organisation

  AstraZeneca R&D MöIndal

• Eudract number

  2011-002308-33

• Research summary

  This study involves the administration of two different drugs for Type 2 Diabetes Mellitus (T2DM); Dapagliflozin and Metformin which will be given by mouth either as a combination tablet or separately. Dapagliflozin is a new drug under clinical development for the possible treatment of T2DM. Metformin is a licensed medication prescribed worldwide for T2DM. In this study we are investigating whether the combination of Dapagliflozin/Metformin (in a single tablet) is equivalent to Dapagliflozin and Metformin when given separately at the same time by mouth on a full stomach (fed state) and on an empty stomach (fasting state).Dapagliflozin is being developed by AstraZeneca and Bristol-Myers Squibb (pharmaceutical companies). So far Dapagliflozin has been given, either alone or in combination with Metformin, to more than 5000 people (including healthy volunteers and patients with T2DM) in clinical trials worldwide. Dapagliflozin inhibits the activity of a protein in the kidneys called ??Sodium glucose co-transporter (SGLT2)?. This results in decrease reabsorption of glucose by the kidneys. The excess glucose is excreted in the urine thereby reducing the risk of blood sugar rising too high. At least 36 healthy male and female volunteers aged 18-55 years will be enrolled in the study to ensure that 32 subjects complete the study. The study involves 6 visits over approximately 9 weeks, which includes 4 periods each of 5 days/4 nights.

• REC name

  HSC REC A

• REC reference

  12/NI/0022

• Date of REC Opinion

  8 Mar 2012

• REC opinion

  Further Information Favourable Opinion