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MechanismM1 receptor antagonists [+1] |
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Drug Highest PhaseApproved |
First Approval Ctry. / Loc.CN |
First Approval Date17 Mar 2020 |
苯环喹溴铵鼻用喷雾剂代谢性相互作用(作用药物:帕罗西汀)试验
[Translation] Metabolic Interaction Trial of Benzcycline Nasal Spray (Interactive Drug: Paroxetine)
本试验通过比较苯环喹溴铵单独用药及与帕罗西汀合并用药条件下苯环喹溴铵的主要药动学参数及药动学特征的变化情况,评价代谢酶CYP2D6的抑制剂与苯环喹溴铵鼻用喷雾剂合并给药后,是否会发生对苯环喹溴铵鼻用喷雾剂的代谢性药物相互作用。
[Translation] This study evaluated whether metabolic drug interactions of benzcyclidine nasal spray would occur after co-administration of inhibitors of the metabolic enzyme CYP2D6 with benzcyclidine nasal spray by comparing the changes in the main pharmacokinetic parameters and pharmacokinetic characteristics of benzcyclidine when it was used alone and in combination with paroxetine.
苯环喹溴铵鼻用喷雾剂180 μg剂量组的单次和多次给药人体药代动力学试验
[Translation] Single and multiple dose pharmacokinetic study of 180 μg bencyclidine nasal spray in humans
对健康受试者进行苯环喹溴铵鼻用喷雾剂180 μg剂量的单次和多次给药人体药代动力学试验,观察健康受试者单次和多次给药后苯环喹溴铵的经时血药浓度,计算主要药代动力学参数,为申报生产和后续临床试验提供参考。
[Translation] A human pharmacokinetic study of single and multiple doses of 180 μg of benzcyclidine nasal spray was conducted on healthy subjects. The time-dependent blood concentration of benzcyclidine bromide after single and multiple doses in healthy subjects was observed, and the main pharmacokinetic parameters were calculated to provide a reference for production application and subsequent clinical trials.
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