[Translation] A single oral administration, randomized, open-label, two-sequence, two-cycle, crossover bioequivalence trial of vonoraphane fumarate tablets in healthy subjects on an empty stomach or after a meal
主要目的:考察中国健康受试者在空腹/餐后条件下单剂量口服江苏利泰尔药业有限
公司(持有人:苏州第壹制药有限公司)生产的富马酸伏诺拉生片与 Takeda
Pharmaceutical Company Limited, Hikari Plant 生产的(持证商:Takeda Pharmaceutical
Company Limited)富马酸伏诺拉生片后的体内药代动力学特征,评价两制剂的生物
等效性;
次要目的:研究单剂量口服富马酸伏诺拉生片(规格:20mg)在中国健康受试者中
的安全性。
[Translation] Main purpose: To investigate the oral administration of a single dose of Jiangsu Litail Pharmaceutical Co., Ltd. to Chinese healthy subjects under fasting/postprandial conditions.
The company (owner: Suzhou First Pharmaceutical Co., Ltd.) produces vonoraphane fumarate tablets and Takeda
Manufactured by Pharmaceutical Company Limited, Hikari Plant (Licensee: Takeda Pharmaceutical
Company Limited) in vivo pharmacokinetic characteristics of vonoraphan fumarate tablets, to evaluate the biological
equivalence;
Secondary purpose: To study the efficacy of a single dose of oral vonoraphan fumarate tablets (strength: 20 mg) in Chinese healthy subjects
security.