Jiangsu Farever Pharmaceutical Co., Ltd.

The main purpose of the study is to use the progesterone vaginal sustained-release gel (specification: 8% (90 mg)/tube) developed and produced by Jiangsu Yuanheng Pharmaceutical Co., Ltd. as the test preparation, and the progesterone vaginal sustained-release gel (trade name: Xue Nuo Tong®, specification: 8% (90 mg)/tube) produced by MERCK SERONO LIMITED and DENDRON BRANDS LIMITED as the reference preparation to evaluate the bioequivalence of the two preparations in healthy postmenopausal female subjects in China. Secondary purpose of the study: To evaluate the safety of single-dose vaginal administration of the test preparation and the reference preparation in healthy postmenopausal female subjects in China.

The main purpose of the study is to use the progesterone vaginal sustained-release gel (specification: 8% (90 mg)/tube) developed and produced by Jiangsu Yuanheng Pharmaceutical Co., Ltd. as the test preparation, and the progesterone vaginal sustained-release gel (trade name: Xue Nuo Tong®, specification: 8% (90 mg)/tube) produced by the licensee MERCK SERONO LIMITED and the manufacturer Fleet laboratories limited as the reference preparation, to preliminarily evaluate the bioequivalence of the two preparations in healthy postmenopausal female subjects in China, and provide a reference for the design of a formal bioequivalence study. Secondary purpose of the study: To evaluate the safety of single-dose vaginal administration of the test preparation and the reference preparation in healthy postmenopausal female subjects in China.

To investigate the differences in the extent and rate of absorption of a single dose of 10 mg/2 mL of the test preparation diazepam rectal gel (specification: 10 mg/2 mL) produced by Jiangsu Yuanheng Pharmaceutical Co., Ltd. or diazepam rectal gel (trade name: Diastat® AcudialTM, specification: 10 mg/2 mL) produced by DPT LABORATORIES, LTD. in healthy subjects under fasting state, evaluate the bioequivalence and safety of the two preparations, and provide a basis for the registration application of the test preparation.