Zhejiang Aisheng Pharmaceutical Co. Ltd.

The pharmacokinetics of a single oral dose of a test formulation, estradiol valerate tablets (1 mg, manufactured by Zhejiang Aisheng Pharmaceutical Co., Ltd.), compared to a reference formulation, estradiol valerate tablets (1 mg, manufactured by DELPHARM Lille S.A.S.), were investigated in healthy female volunteers. The bioequivalence of the two formulations was evaluated. The safety of the test and reference formulations was observed in healthy Chinese volunteers.

The main purpose of the study is to study the pharmacokinetics of the test preparation estradiol tablets/estradiol dydrogesterone tablets in the combined package (specification: 2 mg, produced by Zhejiang Aisheng Pharmaceutical Co., Ltd.) and the reference preparation estradiol tablets/estradiol dydrogesterone tablets in the combined package (trade name: Fentaton®, specification: 2 mg, produced by Abbott Biologicals B.V., certified by Abbott B.V.) in healthy subjects after a single oral administration in the fasting state, and to evaluate the bioequivalence of the two preparations when taken orally in the fasting state. Secondary purpose of the study is to observe the safety of the test preparation and the reference preparation in healthy Chinese subjects.

Main study objectives: To study the pharmacokinetics of the test preparation estradiol tablets/estradiol dydrogesterone tablets in the combined package of test preparation estradiol tablets/estradiol dydrogesterone tablets (specification: containing 2 mg estradiol and 10 mg dydrogesterone, produced by Zhejiang Aisheng Pharmaceutical Co., Ltd.) and the reference preparation estradiol tablets/estradiol dydrogesterone tablets in the combined package of reference preparation estradiol tablets/estradiol dydrogesterone tablets (trade name: Fentaton®, specification: containing 2 mg estradiol and 10 mg dydrogesterone, produced by Abbott Biologicals B.V., certified by Abbott B.V.) in healthy subjects after a single oral administration in the fasting state, and to evaluate the bioequivalence of the two preparations when taken orally in the fasting state. Secondary study objectives: To observe the safety of the test preparation and the reference preparation in healthy Chinese subjects.