[Translation] A randomized, open-label, single-dose, two-cycle, double-crossover bioequivalence study of desogestrel ethinyl estradiol tablets in healthy female subjects of childbearing age after fasting and high-fat meal
预试验:健康育龄女性受试者高脂餐后交叉单次口服两种制剂,测定血药浓度,根据Tmax等参数优化采样时间,为高脂餐后正式试验方案优化提供依据。正式试验:主要研究目的:健康育龄女性受试者空腹和高脂餐后交叉单次口服两种制剂,评价两种制剂在空腹和高脂餐后状态下是否生物等效。次要研究目的:观察受试者的安全性。
[Translation] Preliminary study: healthy female subjects of childbearing age took two preparations orally in a single dose after a high-fat meal, measured blood drug concentration, optimized sampling time according to parameters such as Tmax, and provided a basis for optimizing the formal test plan after a high-fat meal. Formal study: Main research purpose: healthy female subjects of childbearing age took two preparations orally in a single dose after fasting and after a high-fat meal, and evaluated whether the two preparations were bioequivalent in the fasting and high-fat meal states. Secondary research purpose: observe the safety of the subjects.