/ Active, not recruitingNot Applicable 屈螺酮炔雌醇片(II)在健康人群中的生物等效性试验
[Translation] Bioequivalence study of drospirenone ethinyl estradiol tablets (II) in healthy subjects
主要研究目的:
在健康受试者体内,餐后状态下,以Bayer Australia Ltd持证,Bayer Weimar GmbH und Co.KG生产的屈螺酮炔雌醇片(II)(商品名:优思悦,规格:屈螺酮3 mg和炔雌醇0.02 mg)为参比制剂,研究浙江爱生药业有限公司研制的屈螺酮炔雌醇片(II)(受试制剂,规格:炔雌醇0.020 mg和屈螺酮3.000 mg)的吸收速度和吸收程度,评价受试制剂与参比制剂是否具有生物等效性。
次要研究目的:
观察受试制剂和参比制剂在中国健康受试者中的安全性。
[Translation] Main study objectives:
In healthy subjects, in the postprandial state, using Drospirenone Ethinyl Estradiol Tablets (II) (trade name: Yousiyue, specification: 3 mg drospirenone and 0.02 mg ethinyl estradiol) produced by Bayer Weimar GmbH und Co.KG and licensed by Bayer Australia Ltd as the reference preparation, to study the absorption rate and extent of Drospirenone Ethinyl Estradiol Tablets (II) (test preparation, specification: 0.020 mg ethinyl estradiol and 3.000 mg drospirenone) developed by Zhejiang Aisheng Pharmaceutical Co., Ltd., and to evaluate whether the test preparation and the reference preparation are bioequivalent.
Secondary study objectives:
Observe the safety of the test preparation and the reference preparation in healthy Chinese subjects.
/ Active, not recruitingNot Applicable 屈螺酮炔雌醇片(II)在健康人群中的生物等效性试验
[Translation] Bioequivalence study of drospirenone ethinyl estradiol tablets (II) in healthy subjects
主要研究目的:
在健康受试者体内,空腹状态下,以Bayer Australia Ltd持证,Bayer Weimar GmbH und Co.KG生产的屈螺酮炔雌醇片(II)(商品名:优思悦,规格:屈螺酮3 mg和炔雌醇0.02 mg)为参比制剂,研究浙江爱生药业有限公司研制的屈螺酮炔雌醇片(II)(受试制剂,规格:炔雌醇0.020 mg和屈螺酮3.000 mg)的吸收速度和吸收程度,评价受试制剂与参比制剂是否具有生物等效性。
次要研究目的:
观察受试制剂和参比制剂在中国健康受试者中的安全性。
[Translation] Main study objectives:
In healthy subjects, under fasting conditions, using Drospirenone Ethinyl Estradiol Tablets (II) (trade name: Usile, specification: 3 mg drospirenone and 0.02 mg ethinyl estradiol) produced by Bayer Australia Ltd and Bayer Weimar GmbH und Co.KG as the reference preparation, to study the absorption rate and extent of Drospirenone Ethinyl Estradiol Tablets (II) (test preparation, specification: 0.020 mg ethinyl estradiol and 3.000 mg drospirenone) developed by Zhejiang Aisheng Pharmaceutical Co., Ltd., and to evaluate whether the test preparation and the reference preparation are bioequivalent.
Secondary study objectives:
Observe the safety of the test preparation and the reference preparation in healthy Chinese subjects.
/ CompletedNot Applicable [Translation] Bioequivalence study of dydrogesterone tablets in healthy people
研究空腹/餐后状态下单剂量口服受试制剂地屈孕酮片与参比制剂地屈孕酮片在健康女性受试者体内的药代动力学,评价空腹/餐后状态下口服两种制剂的生物等效性。研究受试制剂地屈孕酮片和参比制剂在健康女性受试者中的安全性。
[Translation] To study the pharmacokinetics of a single oral dose of the test preparation Dydrogesterone Tablets and the reference preparation Dydrogesterone Tablets in healthy female subjects in the fasting/postprandial state, and to evaluate the bioequivalence of the two preparations in the fasting/postprandial state. To study the safety of the test preparation Dydrogesterone Tablets and the reference preparation in healthy female subjects.
100 Clinical Results associated with Zhejiang Aisheng Pharmaceutical Co. Ltd.
0 Patents (Medical) associated with Zhejiang Aisheng Pharmaceutical Co. Ltd.
100 Deals associated with Zhejiang Aisheng Pharmaceutical Co. Ltd.
100 Translational Medicine associated with Zhejiang Aisheng Pharmaceutical Co. Ltd.