Zhejiang Aisheng Pharmaceutical Co. Ltd.

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.

Main study objectives: 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 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.