/ Not yet recruitingNot Applicable 阿戈美拉汀片(25 mg)随机、开放、两序列、四周期、完全重复交叉单次空餐后状态下在健康受试者中的生物等效性试验
[Translation] A randomized, open-label, two-sequence, four-period, completely repeated crossover bioequivalence study of agomelatine tablets (25 mg) in healthy volunteers in the single fasting state
在健康男性与女性受试者中于餐后条件下评价受试制剂和参比制剂的生物等效性。
[Translation] The bioequivalence of the test and reference products was evaluated in healthy male and female subjects under fed conditions.
/ Not yet recruitingNot Applicable 枸橼酸坦度螺酮片(10 mg)随机、开放、两序列、四周期、完全重复交叉单次餐后状态下在健康受试者中的生物等效性试验
[Translation] A randomized, open-label, two-sequence, four-period, completely repeated crossover bioequivalence study of tandospirone citrate tablets (10 mg) in healthy subjects under the single fed state
主要目的:
在健康男性与女性受试者中于餐后条件下评价受试制剂和参比制剂的生物等效性。
次要目的:
观察受试制剂与参比制剂在健康受试者中的安全性。
[Translation] Primary objective:
To evaluate the bioequivalence of the test formulation and the reference formulation in healthy male and female subjects under fed conditions.
Secondary objective:
To observe the safety of the test formulation and the reference formulation in healthy subjects.
/ CompletedNot Applicable 富马酸喹硫平缓释片在健康受试者中的随机、开放、交叉生物等效性研究
[Translation] A randomized, open-label, crossover bioequivalence study of quetiapine fumarate extended-release tablets in healthy volunteers
主要目的:研究空腹和餐后状态下健康受试者口服受试制剂富马酸喹硫平缓释片200mg(中仁康博(北京)医药科技有限公司提供)与参比制剂富马酸喹硫平缓释片200mg(AstraZeneca Pharmaceuticals LP公司生产)的体内的药代动力学,评价空腹和餐后状态给药时两种制剂的生物等效性;
次要目的:观察受试制剂和参比制剂在健康受试者中的安全性。
[Translation] Primary objective: To study the pharmacokinetics of the test preparation quetiapine fumarate sustained-release tablets 200 mg (provided by Zhongren Kangbo (Beijing) Pharmaceutical Technology Co., Ltd.) and the reference preparation quetiapine fumarate sustained-release tablets 200 mg (produced by AstraZeneca Pharmaceuticals LP) in healthy subjects in the fasting and fed state, and to evaluate the bioequivalence of the two preparations when administered in the fasting and fed state;
Secondary objective: To observe the safety of the test preparation and the reference preparation in healthy subjects.
100 Clinical Results associated with Zhongren KangBo (Beijing) Pharmaceutical Technology Co., Ltd.
0 Patents (Medical) associated with Zhongren KangBo (Beijing) Pharmaceutical Technology Co., Ltd.
100 Deals associated with Zhongren KangBo (Beijing) Pharmaceutical Technology Co., Ltd.
100 Translational Medicine associated with Zhongren KangBo (Beijing) Pharmaceutical Technology Co., Ltd.