Objective: To evaluate the bioequivalence and safety of generic formulation of alogliptin( test and original brand formulation( reference). Methods: A single-center, randomized, open-label, single-dose, twoperiod, two-sequence and self-crossover study was designed. A total of 48 healthy Chinese subjects were divided into fast group( 24 cases) and fed group( 24 cases). Plasma concentrations of alogliptin were determined by HPLCMS/MS and the pharmacokinetic parameters were calculated using Win Nolin 7. 0. Results: After the volunteers were given tested and reference preparations in fasting state, bioequivalence was evaluated by Cmaxand AUC of alogliptin. The geometric mean ratio of Cmaxwas 102. 65%, the 90% CI was 96. 90% ∼ 108. 74%, and the intra-individual varition was 11. 38%; The geometric mean ratio of AUC0-twas 100. 67%, the 90% CI was 98. 38% ∼ 103. 03%, and the intra-individual varition was 4. 55%; The geometric mean ratio of AUC0-∞was 100. 62%, the 90% CI was98. 19% ∼ 103. 12%, and the intra-individual varition was 4. 83%. After the volunteers were given tested and reference preparations in fed state, bioequivalence was evaluated by Cmaxand AUC of alogliptin. The geometric mean ratio of Cmaxwas 93. 23%, the 90% CI was 88. 17% ∼ 98. 57%, and the intra-individual varition was 11. 28%; The geometric mean ratio of AUC0-twas 97. 62%, the 90% CI was 95. 67% ∼ 99. 60%, and the intra-individual varition was 4. 06%; The geometric mean ratio of AUC0-∞was 97. 38%, the 90% CI was 95. 37% ∼ 99. 43%, and the intra-individual varition was 4. 21%. Conclusions: The generic formulation of alogliptin was bioequivalent to the reference marketed brand under fast and fed states. Both the alogliptin formulations were well tolerated.