[Translation] A single-center, open-label, randomized, single-dose, two-period, two-sequence, crossover bioequivalence study to evaluate the bioequivalence of the test formulation of drospirenone ethinyl estradiol tablets (II) (strength: drospirenone 3 mg and ethinyl estradiol 0.02 mg) and the reference formulation in healthy adult female participants under fasting conditions
主要试验目的:研究空腹状态下单次口服受试制剂屈螺酮炔雌醇片(II)(规格:屈螺酮3 mg和炔雌醇0.02 mg;武汉九珑人福药业有限责任公司生产)与参比制剂屈螺酮炔雌醇片(II)(规格:屈螺酮3 mg和炔雌醇0.02 mg;Bayer Weimar GmbH & Co. KG生产)在健康成年女性参与者体内的药代动力学特征,评价空腹状态口服两种制剂的生物等效性。
次要试验目的:研究受试制剂屈螺酮炔雌醇片(II)(规格:屈螺酮3 mg和炔雌醇0.02 mg)和参比制剂屈螺酮炔雌醇片(规格:屈螺酮3 mg和炔雌醇0.02 mg)在健康成年女性参与者中的安全性。
[Translation] The main purpose of the study is to study the pharmacokinetic characteristics of the test preparation drospirenone ethinylestradiol tablets (II) (specifications: drospirenone 3 mg and ethinylestradiol 0.02 mg; produced by Wuhan Jiulong Renfu Pharmaceutical Co., Ltd.) and the reference preparation drospirenone ethinylestradiol tablets (II) (specifications: drospirenone 3 mg and ethinylestradiol 0.02 mg; produced by Bayer Weimar GmbH & Co. KG) in healthy adult female participants after a single oral administration under fasting conditions, and to evaluate the bioequivalence of the two preparations when taken orally under fasting conditions.
The secondary purpose of the study is to study the safety of the test preparation drospirenone ethinylestradiol tablets (II) (specifications: drospirenone 3 mg and ethinylestradiol 0.02 mg) and the reference preparation drospirenone ethinylestradiol tablets (specifications: drospirenone 3 mg and ethinylestradiol 0.02 mg) in healthy adult female participants.