[Translation] A randomized, open-label, single-dose, two-formulation, two-sequence, two-period crossover bioequivalence study of guanifacin hydrochloride extended-release tablets in healthy participants under fasting/postprandial conditions.
主要目的:健康参与者空腹/餐后状态下,口服单剂量盐酸胍法辛缓释片(Guanfacine Hydrochloride Extended Release Tablets,受试制剂T,海南慧谷药业有限公司生产,规格:2mg/片)与盐酸胍法辛缓释片(Guanfacine Hydrochloride Extended Release Tablets,参比制剂R,Takeda Pharmaceuticals America, Inc持证,Patheon Manufacturing Services LLC生产,商品名:Intuniv®,规格:2mg/片)进行生物等效性试验,研究受试制剂与参比制剂在人体内的吸收速度和吸收程度,评价受试制剂与参比制剂是否具有生物等效性。
次要目的:观察受试制剂和参比制剂在中国健康参与者中的安全性。
[Translation] Primary Objective: To conduct a bioequivalence study of single-dose oral administration of guanfacine hydrochloride extended-release tablets (test formulation T, manufactured by Hainan Huigu Pharmaceutical Co., Ltd., strength: 2 mg/tablet) and guanfacine hydrochloride extended-release tablets (reference formulation R, licensed by Takeda Pharmaceuticals America, Inc., manufactured by Patheon Manufacturing Services LLC, trade name: Intuniv®, strength: 2 mg/tablet) in healthy participants under fasting/postprandial conditions. The aim was to investigate the absorption rate and extent of absorption of the test and reference formulations in humans, and to evaluate their bioequivalence.
Secondary Objective: To observe the safety of the test and reference formulations in healthy participants in China.