健康受试者空腹及餐后状态下口服双氯芬酸钠肠溶片后人体生物等效性试验
[Translation] Human bioequivalence test of oral diclofenac sodium enteric-coated tablets in fasting and postprandial states in healthy subjects
主要目的:以四川天德制药有限公司生产的双氯芬酸钠肠溶片(规格:25 mg)为受试制剂,以北京诺华制药有限公司生产的双氯芬酸钠肠溶片(规格:25 mg,商品名:扶他林®)为参比制剂,进行空腹/餐后状态下人体生物等效性试验,评价受试制剂与参比制剂的生物等效性。
次要目的:观察空腹/餐后状态下,受试制剂和参比制剂在健康受试者中的安全性。
[Translation] Main purpose: Take diclofenac sodium enteric-coated tablets (specification: 25 mg) produced by Sichuan Tiande Pharmaceutical Co., Ltd. as the test preparation, and use diclofenac sodium enteric-coated tablets (specification: 25 mg) produced by Beijing Novartis Pharmaceutical Co., Ltd. Voltaren®) as the reference preparation, the human bioequivalence test in fasting/postprandial state was carried out to evaluate the bioequivalence between the test preparation and the reference preparation.
Secondary objective: To observe the safety of test preparation and reference preparation in healthy subjects in fasting/postprandial state.
健康受试者空腹及餐后状态下口服双氯芬酸钠肠溶片后人体生物等效性试验
[Translation] Human bioequivalence test after oral administration of diclofenac sodium enteric-coated tablets to healthy subjects under fasting and postprandial conditions
主要目的:以四川天德制药有限公司生产的双氯芬酸钠肠溶片(规格:25 mg)为受试制剂,以北京诺华制药有限公司生产的双氯芬酸钠肠溶片(规格:25 mg,商品名:扶他林®)为参比制剂,进行空腹/餐后状态下人体生物等效性试验,评价受试制剂与参比制剂的生物等效性。
次要目的:观察空腹/餐后状态下,受试制剂和参比制剂在健康受试者中的安全性。
[Translation] Main purpose: Diclofenac sodium enteric-coated tablets (specification: 25 mg) produced by Sichuan Tiande Pharmaceutical Co., Ltd. were used as the test preparation, and diclofenac sodium enteric-coated tablets (specification: 25 mg, trade name: Voltaren®) is the reference preparation. Human bioequivalence tests are conducted under fasting/postprandial conditions to evaluate the bioequivalence of the test preparation and the reference preparation.
Secondary purpose: To observe the safety of the test preparation and reference preparation in healthy subjects under fasting/postprandial conditions.
100 Clinical Results associated with Sichuan Tiande Pharmaceutical Co. Ltd.
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100 Translational Medicine associated with Sichuan Tiande Pharmaceutical Co. Ltd.