[Translation] A randomized, open-label, two-formulation, two-period, crossover, fasting and postprandial bioequivalence study of birepiperazole orally disintegrating tablets in healthy human subjects.

主要目的：研究健康受试者在空腹/餐后状态下，单次口服由北京康立生医药技术开发有限公司的布瑞哌唑口崩片2mg（受试制剂）和大冢制药株式会社（Otsuka Pharmaceutical Co.Ltd.）为持证商的布瑞哌唑口崩片2mg（Brexpiprazole Orally Disintegrating Tablets/Rexulti® OD Tablets，参比制剂）的相对生物利用度，评价受试制剂和参比制剂的生物等效性。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 investigate the relative bioavailability of a single oral dose of Brexpiprazole Orally Disintegrating Tablets 2 mg (test formulation) from Beijing Kanglisheng Pharmaceutical Technology Development Co., Ltd., and Brexpiprazole Orally Disintegrating Tablets/Rexulti® OD Tablets (reference formulation) from Otsuka Pharmaceutical Co., Ltd., in healthy subjects under fasting/postprandial conditions, and to evaluate the bioequivalence of the test and reference formulations. Secondary Objective: To observe the safety and tolerability of the test and reference formulations in healthy Chinese subjects by monitoring changes in adverse event rates, laboratory test results, vital signs, and physical examination findings.

Start Date06 May 2026

Sponsor / Collaborator

Beijing Kanglisheng Pharm Tech Development Co. Ltd.

CTR20260589

/ CompletedNot Applicable

巴瑞替尼片在健康人体随机、开放、两制剂、两周期、交叉、空腹生物等效性试验

[Translation] Baricitinib tablets in a randomized, open-label, two-formulation, two-period, crossover, fasting bioequivalence trial in healthy human subjects

主要目的：研究健康受试者在空腹状态下，单次口服北京康立生医药技术开发有限公司的巴瑞替尼片2mg（受试制剂）和礼来制药公司（Eli Lilly Nederland B.V.）为持证商的巴瑞替尼片2mg（Baricitinib Tablets/Olumiant® (艾乐明®)，参比制剂），的相对生物利用度，评价受试制剂和参比制剂的生物等效性。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 investigate the relative bioavailability of a single oral dose of baricitinib tablets 2 mg (test formulation) from Beijing Kanglisheng Pharmaceutical Technology Development Co., Ltd., and baricitinib tablets 2 mg (Olumiant®, reference formulation) from Eli Lilly and Company (licensee Olumiant®), in healthy subjects under fasting conditions, and to evaluate the bioequivalence of the test and reference formulations. Secondary Objective: To observe the safety and tolerability of the test and reference formulations in healthy Chinese subjects by monitoring changes in adverse event rates, laboratory test results, vital signs, and physical examination findings.

Start Date17 Apr 2026

Sponsor / Collaborator

Beijing Kanglisheng Pharm Tech Development Co. Ltd.

CTR20255140

/ CompletedNot Applicable

阿帕他胺片在健康人体随机、开放、两制剂、两周期、双交叉、空腹和餐后生物等效性试验

[Translation] Apalutamide tablets were used in a randomized, open-label, two-formulation, two-period, two-crossover bioequivalence trial in healthy human subjects, including fasting and postprandial studies.

主要目的：研究健康试验参与者在空腹和餐后状态下，单次口服北京康立生医药技术开发有限公司的阿帕他胺片60mg（受试制剂）和Janssen-Cilag International NV为持证商的阿帕他胺片60mg（参比制剂，商品名：Erleada（安森珂））的相对生物利用度，评价受试制剂和参比制剂的生物等效性。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试验参与者中的安全性和耐受性。

[Translation]

Primary Objective: To investigate the relative bioavailability of apalutamide tablets 60 mg (test formulation) from Beijing Kanglisheng Pharmaceutical Technology Development Co., Ltd. and apalutamide tablets 60 mg (reference formulation, brand name: Erleada) from Janssen-Cilag International NV, in healthy participants under fasting and postprandial conditions, and to evaluate the bioequivalence of the test and reference formulations. Secondary Objective: To observe the safety and tolerability of the test and reference formulations in healthy participants in China through changes in adverse event rates, laboratory test results, vital signs, and physical examination findings.

Start Date01 Feb 2026

Sponsor / Collaborator

Beijing Kanglisheng Pharm Tech Development Co. Ltd.

100 Clinical Results associated with Beijing Kanglisheng Pharm Tech Development Co. Ltd.

0 Patents (Medical) associated with Beijing Kanglisheng Pharm Tech Development Co. Ltd.

100 Deals associated with Beijing Kanglisheng Pharm Tech Development Co. Ltd.

100 Translational Medicine associated with Beijing Kanglisheng Pharm Tech Development Co. Ltd.

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