Zhejiang Aisheng Pharmaceutical Co. Ltd.

Primary Objective: To investigate the pharmacokinetics of a single oral dose of the test formulation, estradiol dydrogesterone tablets (containing estradiol (C18H24O2) 0.5 mg and dydrogesterone 2.5 mg, manufactured by Zhejiang Aisheng Pharmaceutical Co., Ltd.), and the reference formulation, estradiol dydrogesterone tablets (trade name: Femoston conti, containing estradiol (C18H24O2) 0.5 mg and dydrogesterone 2.5 mg, manufactured by Abbott Biologicals B.V. and licensed by Mylan Products Ltd.), in healthy participants under fasting/postprandial conditions, and to evaluate the bioequivalence of the two formulations under fasting/postprandial conditions. Secondary Objective: To observe the safety of the test and reference formulations in healthy Chinese participants.

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 fed state, and to evaluate the bioequivalence of the two preparations after oral administration in the fed state. Secondary study objectives: To observe the safety of the test preparation and the reference preparation in healthy Chinese subjects.

The pharmacokinetics of a single oral dose of the test formulation, Netupitant Palonosetron Capsules (manufactured by Zhejiang Aisheng Pharmaceutical Co., Ltd.), compared to the reference formulation, Netupitant Palonosetron Capsules (trade name: Akynzeo, manufactured by Helsinn Birex Pharmaceuticals Ltd.), were investigated in healthy volunteers after fasting and post-feeding. The bioequivalence of the two formulations was evaluated after oral administration in the fasting and post-feeding states. The safety of the test and reference formulations in healthy Chinese volunteers was observed.