Zhejiang Shenzhou Pharmaceutical Co. Ltd.

The main purpose of the study is to evaluate whether the progesterone soft capsules (specification: 100 mg) produced by Zhejiang Shenzhou Pharmaceutical Co., Ltd. and the reference preparation progesterone soft capsules (Utrogestan®) are bioequivalent when taken orally in healthy Chinese adult menopausal female subjects in the fasting/postprandial state. The secondary purpose of the study is to evaluate the safety of the test preparation and the reference preparation in healthy subjects.

Through a small sample size pilot study, the similarity between the progesterone soft capsules (specification: 100 mg) produced by Zhejiang Shenzhou Pharmaceutical Co., Ltd. and the progesterone soft capsules (specification: 100 mg) produced by Cyndea Pharma, S.L. (license holder: Besins Healthcare Benelux) under postprandial conditions was examined to provide a decision basis for whether to enter the formal trial. At the same time, the intra-individual variation of the drug was examined to provide evidence for determining the sample size, blood collection points and analysis methods for the formal trial.

The time course of blood drug concentration after a single oral dose of the test preparation spironolactone tablets (25 mg, produced by Zhejiang Shenzhou Pharmaceutical Co., Ltd.) was observed in healthy subjects in the fasting and postprandial states, and the corresponding pharmacokinetic parameters were estimated. Spironolactone tablets (25 mg, produced by GD SEARLE LLC, USA, trade name: Aldactone®) were used as the reference preparation to evaluate the relative bioavailability and bioequivalence in humans, so as to provide a reference for the registration and clinical application of the drug.