/ Active, not recruitingNot Applicable [Translation] Bioequivalence study of estradiol valerate tablets in human body
主要目的：
比较空腹给药条件下湖南醇健制药科技有限公司提供的戊酸雌二醇片（1 mg）与Jenapharm GmbH & Co. KG持证的戊酸雌二醇片（商品名：Progynova/补佳乐®，1 mg）在中国健康人群吸收程度和吸收速度的差异。
次要目的：
评价空腹条件下，湖南醇健制药科技有限公司提供的戊酸雌二醇片（1 mg）与Jenapharm GmbH & Co. KG持证的戊酸雌二醇片（商品名：Progynova/补佳乐®，1 mg）在中国健康人群体内的安全性。
[Translation] 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.
/ Active, not recruitingNot Applicable [Translation] Bioequivalence study of estradiol valerate tablets in human body
主要目的：
比较餐后给药条件下湖南醇健制药科技有限公司提供的戊酸雌二醇片（1 mg）与Jenapharm GmbH & Co. KG持证的戊酸雌二醇片（商品名：Progynova/补佳乐®，1 mg）在中国健康人群吸收程度和吸收速度的差异。
次要目的：
评价餐后条件下，湖南醇健制药科技有限公司提供的戊酸雌二醇片（1 mg）与Jenapharm GmbH & Co. KG持证的戊酸雌二醇片（商品名：Progynova/补佳乐®，1 mg）在中国健康人群体内的安全性。
[Translation] Primary objective:
To compare the differences in absorption extent and absorption rate 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 postprandial administration.
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 postprandial administration.
/ CompletedNot Applicable 中国健康女性受试者空腹和餐后状态下口服地屈孕酮片的随机、开放、两序列、四周期重复交叉设计生物等效性试验
[Translation] A randomized, open-label, two-sequence, four-period repeated crossover bioequivalence study of oral dydrogesterone tablets in Chinese healthy female subjects in the fasting and fed state
（1）主要研究目的
研究空腹和餐后状态下单次口服受试制剂地屈孕酮片（规格：10mg，湖南醇健制药科技有限公司生产）与参比制剂地屈孕酮片（商品名：达芙通®，规格：10mg，Abbott Biologicals B.V.生产）在中国健康女性受试者体内
的药代动力学，评价两制剂生物等效性。
（2）次要研究目的
评价中国健康女性受试者空腹和餐后单次口服受试制剂（T）地屈孕酮片和参比制剂（R）地屈孕酮片（达芙通®）后的安全性。
[Translation] (1) Main study objectives
To study the pharmacokinetics of the test preparation Dydrogesterone Tablets (specification: 10 mg, produced by Hunan Chunjian Pharmaceutical Technology Co., Ltd.) and the reference preparation Dydrogesterone Tablets (trade name: Daphaston®, specification: 10 mg, produced by Abbott Biologicals B.V.) in healthy Chinese female subjects after a single oral administration in the fasting and fed state, and to evaluate the bioequivalence of the two preparations.
(2) Secondary study objectives
To evaluate the safety of the test preparation (T) Dydrogesterone Tablets and the reference preparation (R) Dydrogesterone Tablets (Daphaston®) after a single oral administration in healthy Chinese female subjects after a fasting and fed state.
100 Clinical Results associated with Hunan Sterol pharmaceutical Co., Ltd
0 Patents (Medical) associated with Hunan Sterol pharmaceutical Co., Ltd
100 Deals associated with Hunan Sterol pharmaceutical Co., Ltd
100 Translational Medicine associated with Hunan Sterol pharmaceutical Co., Ltd
