[Translation] A single-center, randomized, open-label, two-dose, three-sequence, three-period, partially repeated crossover bioequivalence study of phloroglucinol oral lyophilized tablets (80 mg) in healthy Chinese subjects after a single postprandial oral administration
主要目的:评价中国健康受试者餐后条件下单次口服间苯三酚口服冻干片受试制剂(规格:80 mg,持有人:湖北午时医药研究院有限公司)和参比制剂(商品名:Spasfon-lyoc®,规格:80 mg,持有人:Teva Sante)后的药代动力学特点,考察二者在餐后条件下是否具有生物等效性。
次要目的:评估间苯三酚口服冻干片受试制剂(规格:80 mg)和参比制剂(商品名:Spasfon-lyoc®,规格:80 mg)在健康受试者中的安全性。
[Translation] Primary objective: To evaluate the pharmacokinetic characteristics of the test formulation of phloroglucinol oral lyophilized tablets (specification: 80 mg, holder: Hubei Wushi Pharmaceutical Research Institute Co., Ltd.) and the reference formulation (trade name: Spasfon-lyoc®, specification: 80 mg, holder: Teva Sante) after a single oral administration under fed conditions in healthy Chinese subjects, and to investigate whether the two are bioequivalent under fed conditions.
Secondary objective: To evaluate the safety of the test formulation of phloroglucinol oral lyophilized tablets (specification: 80 mg) and the reference formulation (trade name: Spasfon-lyoc®, specification: 80 mg) in healthy subjects.