[Translation] A single-center, open-label, randomized, single-dose, two-period, two-sequence self-crossover bioequivalence trial of oral administration of Pemabet tablets under fasting and fed conditions in healthy study participants
主要研究目的:
以南京海融制药有限公司生产的佩玛贝特片(规格:0.1mg)为受试制剂,以持证商为興和株式会社的佩玛贝特片(规格:0.1mg)为参比制剂,考察两制剂在空腹和餐后状态下单次给药的药代动力学参数及相对生物利用度,评价两制剂是否具有生物等效性。
次要研究目的:
评价受试制剂和参比制剂在健康研究参与者中的安全性。
[Translation] Main research objectives:
Pemabet tablets (specification: 0.1 mg) produced by Nanjing Hairong Pharmaceutical Co., Ltd. was used as the test preparation, and Pemabet tablets (specification: 0.1 mg) produced by the certified manufacturer Kowa Co., Ltd. was used as the reference preparation. The pharmacokinetic parameters and relative bioavailability of the two preparations after single administration in the fasting and postprandial states were investigated to evaluate whether the two preparations were bioequivalent.
Secondary study objectives:
To evaluate the safety of test and reference products in healthy research participants.