Bioequivalence and Food Effect of Heat-Stressed and Non-Heat-stressed Dapagliflozin Tablets

August 2015 e105 fed state; a low fat breakfast was provided in Part A and a high breakfast in Part B. Results: In both parts, the new formulation substantially increased DRL-17822 exposure in fasted state, characterised by Cmax, AUC0-t and AUC0-∞, compared to the current formulation. Following high fat breakfast, DRL-17822 exposure was significantly less using the new formulation compared to the current formulation (P < 0.01). In addition, the new formulation resulted in similar ratios fed/fasted for AUC0-t in following both types of breakfast while the current formulation had a higher ratio after high fat breakfast compared to a low fat breakfast (Table 1, similar ratios were seen for Cmax and AUC0-∞). Conclusion: The new formulation had favourable pharmacokinetic characteristics compared to the current formulation, showing a food effect of only 3-fold, which may relate in more predictable effect profile.