|
|
|
|
|
Inactive Indication- |
Drug Highest PhaseApproved |
First Approval Ctry. / Loc.CN |
First Approval Date01 Jan 1995 |
/ CompletedNot Applicable 达格列净片在健康人体随机、开放、两制剂、两周期、交叉、空腹和餐后生物等效性试验
[Translation] A randomized, open-label, two-dose, two-period, crossover, fasting and fed bioequivalence study of dapagliflozin tablets in healthy volunteers
主要目的:研究健康受试者在空腹/餐后状态下,单次口服由山东鲁抗医药集团赛特有限责任公司生产的达格列净片10mg(受试制剂)和阿斯利康(AstraZenecaAB)为持证商的原研达格列净片10mg(FORXIGA/安达唐,参比制剂)的相对生物利用度,评价受试制剂与参比制剂间的生物等效性。
次要目的:通过不良事件发生率、实验室检验结果、生命体征和体格检查等的变化情况观察受试制剂和参比制剂在中国健康受试者中的安全性和耐受性。
[Translation] Primary objective: To study the relative bioavailability of dapagliflozin tablets 10 mg (test preparation) produced by Shandong Lukang Pharmaceutical Group Saite Co., Ltd. and original dapagliflozin tablets 10 mg (FORXIGA/Andatang, reference preparation) of AstraZeneca AB as the licensee in healthy subjects in the fasting/postprandial state, and to evaluate the bioequivalence between the test preparation and the reference preparation.
Secondary objective: To observe the safety and tolerability of the test preparation and the reference preparation in healthy Chinese subjects through changes in adverse event incidence, laboratory test results, vital signs and physical examinations.
/ CompletedNot Applicable 非那雄胺片在健康人体空腹/餐后状态下的生物等效性试验
[Translation] Bioequivalence study of finasteride tablets in healthy volunteers under fasting/fed conditions
主要目的:本研究以山东鲁抗医药集团赛特有限责任公司研制的非那雄胺片为受试制剂,按生物等效性试验的有关规定,以Organon Pharma(UK) Limited持证的保列治为参比制剂,进行空腹/餐后状态下人体生物等效性试验,评价受试制剂和参比制剂在健康男性受试者体内的生物等效性。
次要目的:观察受试制剂和参比制剂在健康男性受试者中的安全性。
[Translation] Main purpose: This study used finasteride tablets developed by Shandong Lukang Pharmaceutical Group Saite Co., Ltd. as the test preparation. According to the relevant regulations of bioequivalence tests, Proscar licensed by Organon Pharma (UK) Limited was used as the reference preparation. Human bioequivalence tests were conducted in fasting/postprandial states to evaluate the bioequivalence of the test preparation and the reference preparation in healthy male subjects.
Secondary purpose: To observe the safety of the test preparation and the reference preparation in healthy male subjects.
/ CompletedNot Applicable 阿奇霉素片随机、开放、两制剂、三周期、部分重复交叉、健康人体空腹和餐后生物等效性试验
[Translation] A randomized, open-label, two-dose, three-period, partially repeated crossover bioequivalence study of azithromycin tablets in healthy volunteers with fasting and fed diet
研究健康受试者在空腹和餐后状态下,单次口服由山东鲁抗医药集团赛特有限责任公司生产的阿奇霉素片0.25g(受试制剂)和辉瑞制药有限公司生产的阿奇霉素片0.25g(Azithromycin Tablets®/希舒美,参比制剂)的相对生物利用度,评价受试制剂与参比制剂间是否生物等效。
[Translation] To study the relative bioavailability of 0.25 g of azithromycin tablets produced by Shandong Lukang Pharmaceutical Group Saite Co., Ltd. (test preparation) and 0.25 g of azithromycin tablets produced by Pfizer Pharmaceuticals Co., Ltd. (Azithromycin Tablets®/Xisuomei, reference preparation) in healthy subjects under fasting and fed conditions, and to evaluate whether the test preparation and the reference preparation are bioequivalent.
100 Clinical Results associated with Shandong Lukang Pharmaceutical Group Saite Co., Ltd.
0 Patents (Medical) associated with Shandong Lukang Pharmaceutical Group Saite Co., Ltd.
100 Deals associated with Shandong Lukang Pharmaceutical Group Saite Co., Ltd.
100 Translational Medicine associated with Shandong Lukang Pharmaceutical Group Saite Co., Ltd.