Vildagliptin’s 50 mg twice daily immediate release formulation and its 100 mg once daily modified release dosage are therapeutically equivalent

History and objectives: Vildagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor, is available as instant release (IR) tablets that are used twice day at a dose of 50 mg (BID). For once daily (QD) administration, a modified release (MR) formulation of 100 mg was created. The objective of this study was to examine the therapeutic equivalent at steady state under fasting conditions of the formulations of vildagliptin, 100 mg MR QD (test), and 50 mg IR BID (reference).

Methods: This study used healthy adult volunteers in an open-label, randomised, two-period, single- and multiple-dose, two-way crossover, steady state setting. For six days, both vildagliptin preparations were given. The tolerability of both formulations, pharmacokinetic characteristics, and pharmacodynamic equivalency were the endpoints.

Results: Of the 30 participants, 26 finished both treatments. On days 1 and 6, the maximum plasma concentration and exposure attained with the test were lower than those of the reference formulation. Between the formulations, the DPP-4 enzyme inhibition over time (DPP-4-AUEC0-24) was comparable. Both formulas received favourable reviews.

This research supports the clinical equivalentity of vildagliptin IR and MR formulations for long-term DPP-4 enzyme inhibition. According to the study, vildagliptin 100 mg MR QD is a beneficial therapeutic option to the 50 mg IR BID formulation that may increase patient compliance and treatment adherence. This study does not assess the long-term safety of the vildagliptin 100 mg MR QD formulation.

Dipeptidyl-peptidase IV inhibitors, Therapeutic equivalency, Adherence and compliance to Treatment, Pharmacodynamic, Pharmacokinetic Vildagliptin for type 2 diabetes mellitus.



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