|
|
|
|
|
|
Drug Highest PhaseApproved |
First Approval Ctry. / Loc.Japan |
First Approval Date08 Aug 1973 |
/ Active, not recruitingNot Applicable 健康研究参与者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] Bioequivalence study of human participants after oral administration of diclofenac sodium enteric-coated tablets in a postprandial state in a health study.
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:观察餐后状态下,受试制剂和参比制剂在健康研究参与者中的安全性。
[Translation] Primary objective: To evaluate the bioequivalence of diclofenac sodium enteric-coated tablets (25 mg) manufactured by Sichuan Tiande Pharmaceutical Co., Ltd. in humans under postprandial conditions, using diclofenac sodium enteric-coated tablets (25 mg, trade name: Voltaren®) manufactured by Novartis Pharmaceuticals Co., Ltd. in Beijing as the reference formulation.
Secondary objective: To observe the safety of the test and reference formulations in healthy study participants under postprandial conditions.
/ Not yet recruitingPhase 1 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] Bioequivalence study of diclofenac sodium enteric-coated tablets in healthy subjects after fasting and postprandial administration
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®) produced by Beijing Novatis Pharmaceutical Co., Ltd. were used as the reference preparation. Human bioequivalence studies were conducted under fasting/fed conditions to evaluate the bioequivalence of the test preparation and the reference preparation.
Secondary purpose: To observe the safety of the test preparation and the reference preparation in healthy subjects under fasting/fed conditions.
/ Not yet recruitingPhase 1 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] Bioequivalence study of diclofenac sodium enteric-coated tablets in healthy subjects after fasting and postprandial administration
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®) produced by Beijing Novatis Pharmaceutical Co., Ltd. were used as the reference preparation. Human bioequivalence studies were conducted under fasting/fed conditions to evaluate the bioequivalence of the test preparation and the reference preparation.
Secondary purpose: To observe the safety of the test preparation and the reference preparation in healthy subjects under fasting/fed conditions.
100 Clinical Results associated with Sichuan Tiande Pharmaceutical Co. Ltd.
0 Patents (Medical) associated with Sichuan Tiande Pharmaceutical Co. Ltd.
100 Deals associated with Sichuan Tiande Pharmaceutical Co. Ltd.
100 Translational Medicine associated with Sichuan Tiande Pharmaceutical Co. Ltd.