[Translation] A single-center, randomized, open-label, two-formulation, single-dose, two-period, double-crossover fasting bioequivalence study of drospirenone ethinylestradiol tablets (II) in healthy trial participants.

主要目的：以药代动力学参数作为主要终点评价指标，比较在空腹条件下口服受试制剂屈螺酮炔雌醇片（II）（规格：每片含屈螺酮3mg与炔雌醇0.02mg，生产厂家：乐福思健康产业股份公司）与参比制剂屈螺酮炔雌醇片（II）（商品名：优思悦®，规格：屈螺酮3mg和炔雌醇0.02mg，持证商：Bayer Australia Ltd）后在健康成年女性试验参与者体内的药代动力学行为，评价两制剂的生物等效性。次要目的：观察受试制剂和参比制剂在健康成年女性试验参与者中的安全性。

[Translation]

Primary objective: To evaluate the bioequivalence of the test formulation, drospirenone ethinyl estradiol tablets (II) (3 mg drospirenone and 0.02 mg ethinyl estradiol per tablet, manufactured by Lefus Health Industry Co., Ltd.), and the reference formulation, drospirenone ethinyl estradiol tablets (II) (trade name: Yousiyue®, 3 mg drospirenone and 0.02 mg ethinyl estradiol per tablet, licensee: Bayer Australia Ltd.), in healthy adult female participants after oral administration under fasting conditions. Secondary objective: To observe the safety of the test and reference formulations in healthy adult female participants.

Start Date09 Sep 2026

Sponsor / Collaborator

Wuhan Jissbon Sanitary Product Co. Ltd.

CTR20262895

/ Active, not recruitingNot Applicable

屈螺酮炔雌醇片在健康试验参与者中单中心、随机、开放、两制剂、单次给药、两周期、双交叉空腹生物等效性试验

[Translation] A single-center, randomized, open-label, two-formulation, single-dose, two-cycle, double-crossover fasting bioequivalence study of drospirenone ethinylestradiol tablets in healthy participants.

主要目的：以药代动力学参数作为主要终点评价指标，比较在空腹条件下口服受试制剂屈螺酮炔雌醇片（规格：每片含炔雌醇0.03毫克和屈螺酮3毫克，生产厂家：乐福思健康产业股份公司）与参比制剂屈螺酮炔雌醇片（商品名：优思明®Yasmin®，规格：每片含炔雌醇0.03毫克和屈螺酮3毫克，持证商：Bayer Australia Ltd）后在健康成年女性试验参与者体内的药代动力学行为，评价两制剂的生物等效性。。次要目的：观察受试制剂和参比制剂在健康成年女性试验参与者中的安全性。

[Translation]

Primary objective: To evaluate the bioequivalence of the test formulation, drospirenone ethinylestradiol tablets (0.03 mg ethinylestradiol and 3 mg drospirenone per tablet, manufactured by Lefus Health Industries Co., Ltd.), and the reference formulation, drospirenone ethinylestradiol tablets (Yasmin®, 0.03 mg ethinylestradiol and 3 mg drospirenone per tablet, licensee: Bayer Australia Ltd.), in healthy adult female participants after oral administration under fasting conditions. Secondary objective: To observe the safety of the test and reference formulations in healthy adult female participants.

Start Date26 Aug 2026

Sponsor / Collaborator

Wuhan Jissbon Sanitary Product Co. Ltd.

CTR20244534

/ CompletedNot Applicable

屈螺酮炔雌醇片在中国健康志愿者中空腹及餐后状态下的人体生物等效性试验

[Translation] Human bioequivalence study of drospirenone and ethinyl estradiol tablets in Chinese healthy volunteers under fasting and fed conditions

主要目的：研究空腹和餐后状态下单次口服受试制剂屈螺酮炔雌醇片（规格：每片含炔雌醇0.03mg和屈螺酮3mg，乐福思健康产业股份公司生产）与参比制剂屈螺酮炔雌醇片（优思明®，规格：每片含炔雌醇0.03mg和屈螺酮3mg；Bayer Australia Ltd持证，Bayer Weimar GmbH & Co. KG.生产）在健康成年受试者体内的药代动力学特征，评价空腹和餐后状态下口服两种制剂的生物等效性。次要目的：研究受试制剂屈螺酮炔雌醇片（规格：每片含炔雌醇0.03mg和屈螺酮3mg）和参比制剂屈螺酮炔雌醇片（优思明®）（规格：每片含炔雌醇0.03mg和屈螺酮3mg）在健康受试者中的安全性。

[Translation]

Primary objective: To study the pharmacokinetic characteristics of the test preparation drospirenone ethinyl estradiol tablets (specification: each tablet contains 0.03 mg ethinyl estradiol and 3 mg drospirenone, produced by Love Health Industry Co., Ltd.) and the reference preparation drospirenone ethinyl estradiol tablets (Yasmin®, specification: each tablet contains 0.03 mg ethinyl estradiol and 3 mg drospirenone; licensed by Bayer Australia Ltd, produced by Bayer Weimar GmbH & Co. KG.) in healthy adult subjects after single oral administration in fasting and fed state, and to evaluate the bioequivalence of the two preparations after oral administration in fasting and fed state. Secondary objective: To study the safety of the test preparation drospirenone ethinyl estradiol tablets (specification: each tablet contains 0.03 mg ethinyl estradiol and 3 mg drospirenone) and the reference preparation drospirenone ethinyl estradiol tablets (Yasmin®) (specification: each tablet contains 0.03 mg ethinyl estradiol and 3 mg drospirenone) in healthy subjects.

Start Date07 Dec 2024

Sponsor / Collaborator

Wuhan Jissbon Sanitary Product Co. Ltd.

100 Clinical Results associated with Wuhan Jissbon Sanitary Product Co. Ltd.

0 Patents (Medical) associated with Wuhan Jissbon Sanitary Product Co. Ltd.

100 Deals associated with Wuhan Jissbon Sanitary Product Co. Ltd.

100 Translational Medicine associated with Wuhan Jissbon Sanitary Product Co. Ltd.

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