Bioequivalence study of two different dapagliflozin tablet formulations in healthy adult Indian volunteers

Abstract

Objective: To assess the bioequivalence of 10 mg dapagliflozin tablets compared with that of 10 mg Farxiga® (dapagliflozin) tablets of AstraZeneca Pharmaceuticals LP, USA in healthy, adult volunteers under fasting conditions. Materials and Methods: This was an open-label, balanced, randomized, two-treatment, two-period, two-sequence, single-dose, crossover, oral bioequivalence study. Volunteers were randomized to receive either test product or reference product of 10 mg dapagliflozin tablets under the fasting condition with a nine-day washout period. The primary pharmacokinetic (PK) parameters were maximum plasma concentration (Cmax), area under the curve (AUC) at time t (AUCt), and AUC extrapolated to infinity (AUCinf). Adverse events were assessed as safety endpoints. The bioequivalence was assessed to evaluate that the two formulations are not different from one another if the 90% confidence interval for the ratio of the geometric least square means falls completely within the predefined range of 80–125%. Results: Fifty-two healthy adult volunteers were randomized, and 47 completed the study. The mean values for Cmax, AUCt, and AUCinf were almost identical for test and reference products after administration to healthy human volunteers under fasting conditions. A total of 14 adverse events were reported by 10 volunteers during the study. All adverse events were mild to moderate in nature and did not cause study withdrawal. Conclusion: The test product dapagliflozin 10 mg was bioequivalent with the reference product in healthy, adult, human volunteers under fasting conditions. The availability of the affordable generic dapagliflozin has the potential to improve clinical outcomes in millions of patients in India because of its renoprotective, cardioprotective, and glucose-lowering effects.