Indobufen

To compare the pharmacokinetics and safety of indobufen (IDB) tablets and IBUSTRIN®, a randomized, open-label, two-period, two-sequence, single-dose, crossover bioequivalence study was conducted under fasting and fed conditions. A total of 48 eligible subjects were enrolled and randomly assigned to the fasting and fed groups. For each treatment period, participants received a single oral dose of 0.2 g test formulation or reference formulation. Meanwhile, blood samples were continuously collected from the subjects within 36 h after administration, and the safety was monitored throughout the study. The main pharmacokinetic parameters, such as C_max, AUC_0-t, and AUC_0-∞, were calculated using a non-compartmental model. As a result, for the two formulations, bioequivalence analysis showed that the 90% confidence intervals for the geometric mean ratios of the pharmacokinetic parameters were in the range of 80-125% in both fasting and fed groups. Therefore, the test and reference drugs of IDB were proved to be bioequivalent under the fasting and fed conditions, and they were safe and well tolerated after administration.