/ CompletedNot Applicable 甲泼尼龙片在健康受试者中随机、开放、两制剂、单次给药、两周期、两序列餐后状态下的生物等效性试验
[Translation] A randomized, open-label, two-formulation, single-dose, two-cycle, two-sequence bioequivalence study of methylprednisolone tablets in healthy subjects under fed conditions
主要目的:以武汉九珑人福药业有限责任公司生产的甲泼尼龙片为受试制剂,按生物等效性试验的有关规定,与Pfizer Italia Srl生产的甲泼尼龙片(商品名:美卓乐®,参比制剂)对比在健康人体内的吸收速度及吸收程度,考察两制剂的人体生物等效性。
次要目的:观察受试制剂甲泼尼龙片和参比制剂甲泼尼龙片(美卓乐®)在健康受试者中的安全性。
[Translation] Main purpose: To compare the absorption rate and extent of methylprednisolone tablets produced by Wuhan Jiulong Renfu Pharmaceutical Co., Ltd. with methylprednisolone tablets (trade name: Medrol®, reference preparation) produced by Pfizer Italia Srl in healthy human bodies according to the relevant provisions of bioequivalence test, and to investigate the bioequivalence of the two preparations in humans.
Secondary purpose: To observe the safety of the test preparation methylprednisolone tablets and the reference preparation methylprednisolone tablets (Metrol®) in healthy subjects.
/ CompletedNot Applicable 戊酸雌二醇片在中国健康绝经后女性参与者中单中心、随机、开放、两周期、自身交叉、单次给药的空腹和餐后状态下生物等效性研究
[Translation] A single-center, randomized, open-label, two-period, self-crossover, single-dose bioequivalence study of estradiol valerate tablets in healthy Chinese postmenopausal female participants under fasting and fed conditions
主要目的:考察空腹及餐后状态下单次口服受试制剂戊酸雌二醇片(规格:1 mg/片,武汉九珑人福药业有限责任公司生产)与参比制剂戊酸雌二醇片(补佳乐®,规格:1 mg/片;Jenapharm GmbH & Co. KG持证)在中国健康绝经后女性参与者体内的药代动力学特征,评价空腹及餐后状态口服两种制剂的生物等效性。次要目的:考察受试制剂戊酸雌二醇片(规格:1 mg/片)和参比制剂戊酸雌二醇片(补佳乐®,规格:1 mg/片)在中国健康绝经后女性参与者中的安全性。
[Translation] Primary objective: To investigate the pharmacokinetic characteristics of the test preparation estradiol valerate tablets (specification: 1 mg/tablet, produced by Wuhan Jiulong Renfu Pharmaceutical Co., Ltd.) and the reference preparation estradiol valerate tablets (Progynova®, specification: 1 mg/tablet; certified by Jenapharm GmbH & Co. KG) in healthy Chinese postmenopausal female participants after a single oral administration in the fasting and fed state, and to evaluate the bioequivalence of the two preparations in the fasting and fed state. Secondary objective: To investigate the safety of the test preparation estradiol valerate tablets (specification: 1 mg/tablet) and the reference preparation estradiol valerate tablets (Progynova®, specification: 1 mg/tablet) in healthy Chinese postmenopausal female participants.
/ CompletedNot Applicable 布洛芬混悬液在健康受试者中随机、开放、两制剂、单次给药、双周期、双交叉空腹和餐后状态下的生物等效性试验
[Translation] A randomized, open-label, two-dose, single-dose, two-period, double-crossover bioequivalence study of ibuprofen suspension in healthy subjects under fasting and fed conditions
主要目的:以武汉九珑医药有限责任公司持证(武汉人福药业有限责任公司生产)的布洛芬混悬液为受试制剂,以上海强生制药有限公司生产的布洛芬混悬液(商品名:美林®)为参比制剂,考察两制剂在空腹及餐后状态下单次给药的药代动力学参数及相对生物利用度,评价两制剂是否具有生物等效性。
次要目的:评价中国健康受试者单次空腹/餐后口服布洛芬混悬液受试制剂和参比制剂后的安全性。
[Translation] Primary objective: Using the ibuprofen suspension licensed by Wuhan Jiulong Pharmaceutical Co., Ltd. (produced by Wuhan Renfu Pharmaceutical Co., Ltd.) as the test preparation and the ibuprofen suspension (trade name: Meilin®) produced by Shanghai Johnson Pharmaceutical Co., Ltd. as the reference preparation, the pharmacokinetic parameters and relative bioavailability of the two preparations after a single administration in the fasting and postprandial state were investigated to evaluate whether the two preparations are bioequivalent.
Secondary objective: To evaluate the safety of the ibuprofen suspension test preparation and reference preparation after a single oral administration in fasting/postprandial state in healthy Chinese subjects.
100 Clinical Results associated with Wuhan Jiulong Renfu Pharmaceutical Co., Ltd.
0 Patents (Medical) associated with Wuhan Jiulong Renfu Pharmaceutical Co., Ltd.
100 Deals associated with Wuhan Jiulong Renfu Pharmaceutical Co., Ltd.
100 Translational Medicine associated with Wuhan Jiulong Renfu Pharmaceutical Co., Ltd.