Shenzhen Foncoo Pharmaceutical Co. Ltd.

This study aims to study the pharmacokinetic characteristics of a single fasting and postprandial oral dose of dydrogesterone tablets (10 mg) produced by Mankind Pharma Limited, India in healthy subjects; using dydrogesterone tablets (Duphaston®, 10 mg) produced by Abbott Healthcare Products B.V. as the reference preparation, compare the pharmacokinetic parameters Cmax, AUC0-t, and AUC0-∞ of the two preparations, and evaluate the bioequivalence of the two preparations in humans. Secondary objective: To evaluate the safety of the test preparation and the reference preparation in healthy subjects.

Main research purpose: This study uses peropilone hydrochloride tablets (specification: 8 mg) licensed by Shenzhen Pangu Pharmaceutical Co., Ltd. as the test preparation, and peropilone hydrochloride tablets licensed by Dainippon Sumitomo Co., Ltd. Tablets (trade name: Lullan, specification: 8 mg) are reference preparations. Human bioequivalence tests were conducted under fasting/postprandial conditions to evaluate the bioequivalence of the test preparation and the reference preparation in healthy subjects. The purpose of this study is to observe the safety of the test preparation and reference preparation in healthy subjects.

The main purpose of the study is to investigate the pharmacokinetic characteristics of a single oral dose of the test preparation (specification: 10 mg) provided by Shenzhen Pan-Gu Pharmaceutical Co., Ltd. and a single oral dose of the reference preparation (trade name: Brintellix®, specification: 10 mg) certified by H.Lundbeck A/S in healthy subjects under fasting and postprandial conditions, to evaluate the bioequivalence between the two preparations, and to provide a basis for the registration application of the test preparation. The secondary purpose of the study is to observe the safety of a single oral dose of the test preparation (specification: 10 mg) or the reference preparation (trade name: Brintellix®, specification: 10 mg) in healthy subjects under fasting and postprandial conditions.