[Translation] Bioequivalence study of sulindac tablets in healthy subjects in a randomized, open-label, two-formulation, single-dose, two-sequence, two-period, crossover fasting state and in healthy subjects in a randomized, open-label, two-formulation, single-dose, two-sequence, four-period, fully repeated crossover fed state
主要研究目的
研究空腹和餐后状态下单次口服受试制剂舒林酸片(规格:0.2g,成都通德药业有限公司生产,苏州朗科生物技术股份有限公司提供)与参比制剂舒林酸片(Sulindac®,规格:200mg;Watson Pharma Private Ltd.生产,WATSON LABORATORIES INC持证)在人体内的药代动力学,评价空腹和餐后状态口服两种制剂的生物等效性。
次要研究目的
评价中国健康受试者空腹和餐后单次口服受试制剂舒林酸片和参比制剂舒林酸片(Sulindac®)后的安全性。
[Translation] Main study objectives
To study the pharmacokinetics of the test preparation sulindac tablets (specification: 0.2g, produced by Chengdu Tongde Pharmaceutical Co., Ltd., provided by Suzhou Langke Biotechnology Co., Ltd.) and the reference preparation sulindac tablets (Sulindac®, specification: 200mg; produced by Watson Pharma Private Ltd., licensed by WATSON LABORATORIES INC) in humans after a single oral administration in the fasting and fed state, and to evaluate the bioequivalence of the two preparations after oral administration in the fasting and fed state.
Secondary study objectives
To evaluate the safety of the test preparation sulindac tablets and the reference preparation sulindac tablets (Sulindac®) after a single oral administration in fasting and fed state in healthy Chinese subjects.