[Translation] Pre-evaluation of the test preparation Norgestromin and ethinyl estradiol patch (specification: norgestromin 150 μg/day; ethinyl estradiol 35 μg/day) and the reference preparation XULANE® (specification: norgestromin 150 μg/day) day; ethinyl estradiol 35 μg/day) single-center, open-label, randomized, single-dose, three-cycle, six-sequence, crossover bioequivalence and adhesion trial in healthy female participants under topical conditions
主要试验目的:研究外用条件下单次给予受试制剂诺孕曲明炔雌醇贴片(规格:诺孕曲明150 μg/天;炔雌醇35 μg/天,新领医药技术(深圳)有限公司生产)与参比制剂XULANE®(规格:诺孕曲明150 μg/天;炔雌醇35μg/天;持证商Mylan Technologies Inc.)在健康女性参与者体内的药代动力学特征和黏附力,为正式人体生物等效性和黏附力试验提供参考。
次要试验目的:研究受试制剂诺孕曲明炔雌醇贴片(规格:诺孕曲明150 μg/天;炔雌醇35 μg/天)和参比制剂XULANE®(规格:诺孕曲明150μg/天;炔雌醇35 μg/天)在健康参与者中的安全性。
[Translation] Main purpose of the test: To study the single administration of the test preparation norgestromin and ethinyl estradiol patch under external use conditions (specification: norgestromin 150 μg/day; ethinyl estradiol 35 μg/day, Xinling Medical Technology (Shenzhen) Co., Ltd.) and the reference preparation XULANE® (specification: norgestramine 150 μg/day; ethinyl estradiol 35 μg/day; license holder Mylan Technologies Inc.) in healthy female participants. Adhesion, providing reference for formal human bioequivalence and adhesion testing.
Secondary trial purpose: To study the test preparation norgestromin and ethinyl estradiol patch (specification: norgestramine 150 μg/day; ethinyl estradiol 35 μg/day) and the reference preparation XULANE® (specification: norgestramine The safety of ethinyl estradiol 150 μg/day; ethinyl estradiol 35 μg/day) in healthy participants.