盐酸氯哌丁片随机、开放、两周期、两交叉健康人体空腹和餐后状态下生物等效性试验
[Translation] Randomized, open-label, two-cycle, two-crossover bioequivalence trial of cloperidine hydrochloride tablets in fasting and postprandial states
主要目的:研究健康受试者在空腹/餐后状态下,单次口服由辽源市百康药业有限责任公司生产的盐酸氯哌丁片(受试制剂,10mg/片)和ニプロES ファーマ株式会社生产的盐酸氯哌丁片(参比制剂,10mg/片)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] Main purpose: To study the healthy subjects taking a single oral dose of cloperidine hydrochloride tablets (tested preparation, 10mg/tablet) and NIPROES ファーマ produced by Liaoyuan Baikang Pharmaceutical Co., Ltd. The relative bioavailability of cloperidine hydrochloride tablets (reference preparation, 10 mg/tablet) produced by the company was evaluated, and the bioequivalence between the test preparation and the reference preparation was evaluated.
Secondary objective: To observe the safety and tolerability of the test and reference preparations in healthy Chinese subjects through changes in the incidence of adverse events, laboratory test results, vital signs and physical examinations.
盐酸氯哌丁片随机、开放、两周期、两交叉健康人体空腹和餐后状态下生物等效性试验
[Translation] Randomized, open-label, two-cycle, two-crossover bioequivalence trial of cloperidine hydrochloride tablets in fasting and postprandial states
主要目的:研究健康受试者在空腹/餐后状态下,单次口服由辽源市百康药业有限责任公司生产的盐酸氯哌丁片(受试制剂,10mg/片)和ニプロES ファーマ株式会社生产的盐酸氯哌丁片(参比制剂,10mg/片)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] Main purpose: To study the healthy subjects taking a single oral dose of cloperidine hydrochloride tablets (tested preparation, 10mg/tablet) and NIPROES ファーマ produced by Liaoyuan Baikang Pharmaceutical Co., Ltd. The relative bioavailability of cloperidine hydrochloride tablets (reference preparation, 10 mg/tablet) produced by the company was evaluated, and the bioequivalence between the test preparation and the reference preparation was evaluated.
Secondary objective: To observe the safety and tolerability of the test and reference preparations in healthy Chinese subjects through changes in the incidence of adverse events, laboratory test results, vital signs and physical examinations.
100 Clinical Results associated with Liaoyuan Baikang Pharmaceutical Co., Ltd.
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100 Deals associated with Liaoyuan Baikang Pharmaceutical Co., Ltd.
100 Translational Medicine associated with Liaoyuan Baikang Pharmaceutical Co., Ltd.