目的 评价健康成年人服用美沙拉秦肠溶片后在空腹、餐后条件下的生物等效性。方法 采用双制剂、双序列、四周期、完全重复交叉的试验方案，空腹和餐后分别入组46例，po 0.5 g美沙拉秦肠溶片，采用LC-MS/MS法测定美沙拉秦的血药浓度，用Phoenix WinNonlin 8.3软件计算对应受试者的药动学参数。结果 健康受试者空腹、餐后条件下，几何均值比的点估计值均处于可接受范围[80.00%～125.00%]。结论 美沙拉秦肠溶片的受试制剂与参比制剂在健康受试者中单次空腹、餐后口服后生物等效。

Objective To evaluate the bioavailability of Mesalazine Enteric-coated Tablets in healthy adults under fasting and fed conditions. Methods A two-formulation, two-sequence, four-period, fully replicated crossover bioequivalence study was conducted, with 46 subjects under fasting and fed conditions, and they were po administered with Mesalazine Enteric-coated Tablets 0.5 g. Plasma concentrations of mesalazine were determined using LC-MS/MS. Pharmacokinetic parameters were calculated using Phoenix WinNonlin software (version 8.3). Results The point estimates of the geometric mean ratios in healthy adults under fasting and fed conditions fell within the acceptable range of 80.00% — 125.00%. Conclusion The test formulation of Mesalazine Enteric-coated Tablets and the reference formulation were bioequivalent under fasting and fed conditions in healthy adult subjects.

R969.1