[Translation] A single-center, randomized, open-label, two-sequence, two-period crossover bioequivalence trial of a single oral dose of desogestrel ethinyl estradiol tablets in Chinese healthy female volunteers, either fasting or after a meal
主要目的:
为研究空腹和餐后状态下单次口服去氧孕烯炔雌醇片受试制剂(0.150 mg/0.020 mg片;西班牙Laboratorios Leon Farma,S.A.公司)与参比制剂(Mercilon®;0.15 mg/20 μg,N.V. Organon)后去氧孕烯代谢物3-酮去氧孕烯和炔雌醇在中国健康女性受试者体内的药代动力学特征,评价空腹和餐后状态下口服两种制剂的生物等效性。
次要目的:
为评价中国健康女性受试者单次口服去氧孕烯炔雌醇片受试制剂和参比制剂后的安全性。
[Translation] Primary objective:
To investigate the pharmacokinetic characteristics of the desogestrel metabolites 3-ketodesogestrel and ethinylestradiol in healthy Chinese female subjects after a single oral administration of the test formulation of desogestrel ethinylestradiol tablets (0.150 mg/0.020 mg tablets; Laboratorios Leon Farma, S.A., Spain) and the reference formulation (Mercilon®; 0.15 mg/20 μg, N.V. Organon) in fasting and fed states, and to evaluate the bioequivalence of the two formulations in fasting and fed states.
Secondary objective:
To evaluate the safety of the test formulation of desogestrel ethinylestradiol tablets and the reference formulation in healthy Chinese female subjects after a single oral administration.