[Translation] A randomized, open-label, single-dose, two-formulation, two-period, two-sequence, crossover design bioequivalence study of indobufen tablets in healthy subjects under fasting and fed conditions
主要目的:
评价健康受试者在空腹和餐后状态下口服湖南千金协力药业有限公司生产的受试制剂吲哚布芬片与Pfizer Italia S.r.l生产的参比制剂吲哚布芬片(Ibustrin®)后的生物等效性。
次要目的:
观察受试制剂吲哚布芬片与参比制剂吲哚布芬片(Ibustrin®)在健康受试者中的安全性。
[Translation] Primary objective:
To evaluate the bioequivalence of the test preparation indobufen tablets produced by Hunan Qianjin Xieli Pharmaceutical Co., Ltd. and the reference preparation indobufen tablets (Ibustrin®) produced by Pfizer Italia S.r.l. in healthy subjects after oral administration in fasting and fed state.
Secondary objective:
To observe the safety of the test preparation indobufen tablets and the reference preparation indobufen tablets (Ibustrin®) in healthy subjects.