Pharmaceutical Factory of Chengdu HuaSun Group Inc., Ltd.

Main study purpose This study uses voriconazole tablets (specification: 50 mg) produced by Chengdu Huashen Technology Group Co., Ltd. Pharmaceutical Factory as the test preparation, and voriconazole tablets (trade name: Vfend®/Vfend®; specification: 50 mg) produced by Pfizer Italia S.r.l and licensed by Pfizer Europe Ma EEIG as the reference preparation. The pharmacokinetic parameters of the test preparation and the reference preparation in healthy subjects under fasting state are investigated to evaluate the bioequivalence of the two preparations. Secondary study purpose Observe the safety of the test preparation and the reference preparation in healthy subjects.

A randomized crossover self-control method was designed for 24 healthy male volunteers, who took Sanqi Tongshu Capsules (enteric-coated micropellets) and Sanqi Tongshu Capsules orally on an empty stomach, respectively. The "blood concentration-time" curves of ginsenoside Rg1, ginsenoside Re, and Sanqi saponin R1 were established to compare the bioequivalence of the main active ingredients of the two preparations in the human body during absorption, providing a basis for the production of Sanqi Tongshu Capsules (enteric-coated micropellets) and rational clinical use of the drug.