China Resources Zizhu Pharmaceutical Co., Ltd.

Main study objectives To study the pharmacokinetic behavior of the test preparation Tibolone Tablets (Specification: 2.5mg/tablet; license holder and manufacturer: China Resources Zizhu Pharmaceutical Co., Ltd.) and the reference preparation Tibolone Tablets (trade name: Livial®, specification: 2.5mg/tablet, license holder and manufacturer: N.V. Organon) in healthy postmenopausal female subjects in China after a single oral administration in fasting and postprandial states, and to evaluate the bioequivalence of the two preparations after a single oral administration in fasting and postprandial states. Secondary study objectives To evaluate the safety of the test preparation Tibolone Tablets and the reference preparation Tibolone Tablets (Livial®) in healthy postmenopausal female subjects in China after a single oral administration.

Main research purpose: According to the relevant provisions of bioequivalence test, the estradiol tablets (specification: 2 mg) in the estradiol tablets/estradiol dydrogesterone tablets composite package (trade name: Femoston®, specification: estradiol tablets contain 2 mg estradiol; estradiol dydrogesterone tablets contain 2 mg estradiol and 10 mg dydrogesterone) produced by Abbott Biologicals B.V. were selected as the reference preparation, and the test preparation estradiol tablets (specification: 2 mg) produced and provided by China Resources Zizhu Pharmaceutical Co., Ltd. were subjected to fasting and fed human bioequivalence tests to compare whether the absorption rate and degree of the drug in the test preparation were within the acceptable range with the reference preparation, and to evaluate the bioequivalence of the two preparations under fasting and fed conditions. Secondary study objective: To observe the safety of oral administration of the test preparation estradiol tablets (specification: 2 mg) and the reference preparation estradiol tablets/estradiol dydrogesterone tablets combined package (trade name: Femoston®, specifications: estradiol tablets containing estradiol 2 mg; estradiol dydrogesterone tablets containing estradiol 2 mg and dydrogesterone 10 mg) to healthy subjects.

Main research purpose: According to the relevant provisions of bioequivalence test, the estradiol tablets/estradiol dydrogesterone tablets combined package (trade name: Femoston®, specifications: estradiol tablets contain 2 mg estradiol; estradiol dydrogesterone tablets contain 2 mg estradiol and 10 mg dydrogesterone) produced by Abbott Biologicals B.V. were selected as the reference preparation, and the test preparation estradiol dydrogesterone tablets (specifications: estradiol dydrogesterone tablets contain 2 mg estradiol and 10 mg dydrogesterone) produced and provided by China Resources Zizhu Pharmaceutical Co., Ltd. were subjected to fasting and fed human bioequivalence test, to compare whether the absorption rate and degree of the drug in the test preparation were within the acceptable range with the reference preparation, and to evaluate the bioequivalence of the two preparations under fasting and fed conditions. Secondary study objective: To observe the safety of oral administration of the test preparation estradiol dydrogesterone tablets (specification: estradiol dydrogesterone tablets containing 2 mg estradiol and 10 mg dydrogesterone) and the reference preparation estradiol tablets/estradiol dydrogesterone tablets combined package (trade name: Femoston®, specification: estradiol tablets containing 2 mg estradiol; estradiol dydrogesterone tablets containing 2 mg estradiol and 10 mg dydrogesterone) in healthy subjects (specification: 2 mg/10 mg).