[Translation] A randomized, open-label, two-period, double-crossover fasting and postprandial bioequivalence study of levonorgestrel tablets in healthy female subjects
主要目的:以广州朗圣药业有限公司研制的左炔诺孕酮片(规格:1.5 mg)为受试制剂,按生物等效性研究的有关规定,与匈牙利吉瑞大药厂Gedeon Richter Plc.公司生产的左炔诺孕酮片(参比制剂,商品名:保仕婷®,规格:1.5 mg)对比在健康女性受试者中的相对生物利用度,考察两制剂的人体生物等效性。
次要目的:观察受试制剂左炔诺孕酮片和参比制剂(商品名:保仕婷®)在健康女性受试者中的安全性。
[Translation] Main purpose: Taking levonorgestrel tablets (specification: 1.5 mg) developed by Guangzhou Langsheng Pharmaceutical Co., Ltd. .The relative bioavailability of levonorgestrel tablets produced by the company (reference preparation, trade name: Baoshiting®, specification: 1.5 mg) was compared in healthy female subjects, and the human bioequivalence of the two preparations was investigated. sex.
Secondary purpose: To observe the safety of the test preparation levonorgestrel tablets and the reference preparation (trade name: Baoshiting®) in healthy female subjects.