Hunan Sterol pharmaceutical Co., Ltd

Main purpose of the study: According to the relevant provisions of bioequivalence tests, Gedeon Richter Plc. was selected as the reference preparation for levonorgestrel tablets (trade name: Baoshiting®, specification: 1.5 mg), and the test preparation levonorgestrel tablets (specification: 1.5 mg) produced by Beijing Famosda Pharmaceutical Technology Co., Ltd. and provided by Hunan Chunjian Pharmaceutical Technology Co., Ltd. were used for human bioequivalence tests on fasting and postprandial administration. The absorption rate and degree of the drug in the test preparation were compared with those of the reference preparation to see if they were within an acceptable range, and the bioequivalence of the two preparations under fasting and postprandial administration conditions was evaluated. Secondary purpose of the study: To observe the safety of oral administration of the test preparation levonorgestrel tablets (specification: 1.5 mg) and the reference preparation levonorgestrel tablets (trade name: Baoshiting®, specification: 1.5 mg) by healthy subjects.

Main study objectives: To study the pharmacokinetic behavior of estradiol tablets (specification: containing 2 mg estradiol; licensee and manufacturer: Hunan Chunjian Pharmaceutical Technology Co., Ltd.) in the test preparation estradiol tablets/estradiol dydrogesterone tablets combined package and estradiol tablets (specification: containing 2 mg estradiol; licensee: Abbott B.V., manufacturer: Abbott Biologicals B.V.) in the reference preparation estradiol tablets/estradiol dydrogesterone tablets combined package (trade name: Fentaton®) in healthy postmenopausal female subjects in China, and to evaluate the bioequivalence of the two preparations of estradiol tablets in the fasting and postprandial states. Secondary study objectives: To evaluate the safety of the two preparations of estradiol tablets in the estradiol tablets/estradiol dydrogesterone tablets combined package in healthy postmenopausal female subjects in China after a single oral administration in the fasting/postprandial states.

Primary objective: To compare the differences in the degree and rate of absorption of estradiol valerate tablets (1 mg) provided by Hunan Chunjian Pharmaceutical Technology Co., Ltd. and estradiol valerate tablets (trade name: Progynova/Bujiale®, 1 mg) certified by Jenapharm GmbH & Co. KG in healthy Chinese population under fasting conditions. Secondary objective: To evaluate the safety of estradiol valerate tablets (1 mg) provided by Hunan Chunjian Pharmaceutical Technology Co., Ltd. and estradiol valerate tablets (trade name: Progynova/Bujiale®, 1 mg) certified by Jenapharm GmbH & Co. KG in healthy Chinese population under fasting conditions.