目的 分析贝前列素钠片受试制剂与参比制剂在健康受试者中生物等效性。方法 采用单中心、随机、开放、四周期、完全重复交叉设计，受试者于空腹或餐后状态下口服两种贝前列素钠片40 μg（2片×20 μg/片）。采用LC-MS/MS测定人血浆中贝前列素，通过Phoenix WinNonlin^® 8.3软件计算药动学参数，分析两种制剂等效性。结果 在空腹和餐后状态下最大血药浓度（C_max）、AUC_0-t和AUC_0-∞的几何均值比及其90% CI均完全落入80.00%～125.00%。结论 贝前列素钠片受试制剂和参比制剂在健康受试者空腹和餐后状态下单次给药后生物等效。

Objective To analyze the bioequivalence of Beraprost Sodium Tablets test formulation and the reference formulation in healthy subjects. Methods A single-center, randomized, open-label, four-period, two-sequence, replicated crossover design was employed. Subjects received a single oral dose of Beraprost Sodium Tablets 40 μg (2 × 20 μg tablets) under fasting or fed conditions. Plasma concentrations of beraprost were determined using LC-MS/MS method. Pharmacokinetic parameters were calculated using Phoenix WinNonlin^® 8.3 software, and bioequivalence between two formulations was assessed. Results The geometric mean ratios of C_max、AUC_0-t, AUC_0-∞ in fasting and fed states, along with their 90% confidence intervals, all fell entirely within the range of 80.00% to 125.00%. Conclusion The test and reference formulations of Beraprost Sodium Tablets are bioequivalence after a single dose in healthy subjects under both fasting and fed conditions.

R973