[Translation] Randomized, open-label, two-preparation, three-period, three-crossover human bioequivalence study of britinib enteric-coated capsules under fasting administration conditions
主要研究目的
考察健康受试者在空腹条件下,单次口服3粒经生产场地变更后的伯瑞替尼肠溶胶囊(受试制剂T,规格:100mg/粒)或3粒生产场地变更前的伯瑞替尼肠溶胶囊(参比制剂R,规格:100mg/粒)的药动学特征,评价两制剂间的生物等效性。
次要研究目的
观察健康受试者空腹条件下单次口服受试制剂与参比制剂伯瑞替尼肠溶胶囊的安全性。
[Translation] Main research purpose
Investigate healthy subjects under fasting conditions, orally orally 3 capsules of britinib enteric-coated capsules (test preparation T, specification: 100mg/capsule) after the change of production site or 3 capsules of Buritinib before the change of production site Pharmacokinetic characteristics of Tini enteric-coated capsules (reference preparation R, specification: 100mg/capsule), and evaluate the bioequivalence between the two preparations.
Secondary research purpose
To observe the safety of single oral administration of the test preparation and the reference preparation britinib enteric-coated capsules under fasting conditions in healthy subjects.