[Translation] A single-center, randomized, open-label, single-dose, two-period, crossover bioequivalence study to evaluate the bioequivalence of the test formulation, Luqubopa tablets (strength: 3 mg), and the reference formulation, Luqubopa tablets (Mulpleta® strength: 3 mg), in healthy adult subjects in the fed state.
主要研究目的:以Shionogi Inc.持证的芦曲泊帕片(规格:3mg,商品名:Mulpleta®)为参比制剂,以郑州泰丰制药有限公司研发的芦曲泊帕片(规格:3mg)为受试制剂,通过单中心、随机、开放、两制剂、单次给药、两序列、两周期、双交叉设计的临床研究来评价两种制剂在餐后状态下的人体生物等效性。
次要研究目的:观察受试制剂和参比制剂在中国健康受试者中的安全性。
[Translation] The primary study objective was to evaluate the bioequivalence of Shionogi Inc.'s licensed Luqubopa tablets (3 mg, trade name: Mulpleta®) as the reference formulation and Zhengzhou Taifeng Pharmaceutical Co., Ltd.'s Luqubopa tablets (3 mg) as the test formulation in a single-center, randomized, open-label, two-dose, single-dose, two-sequence, two-period, double-crossover clinical study in the fed state.
The secondary study objective was to observe the safety of the test and reference formulations in healthy Chinese volunteers.