Jiangxi Aishite Pharmaceutical Co., Ltd.

Main study objectives: To compare the bioavailability of the test preparation of amphotericin B liposomes for injection provided by Jiangxi Aishite Pharmaceutical Co., Ltd. with that of the amphotericin B liposomes for injection produced by Gilead Sciences, Inc. (trade name: AmBisome®, reference preparation) in healthy subjects, and to investigate the bioequivalence of the two preparations in humans. Secondary study objectives: To observe the safety of the test preparation of amphotericin B liposomes for injection and the reference preparation of amphotericin B liposomes for injection (AmBisome®) in healthy subjects.

In this study, indacaterol glycopyrronium bromide inhalation powder produced by Jiangxi Aishite Pharmaceutical Co., Ltd. was used as the test preparation (T), and indacaterol glycopyrronium bromide inhalation powder (trade name: Jierun®) certified by Novartis Pharma Schweiz AG was used as the reference preparation (R). The bioequivalence of the test preparation (T) and the reference preparation (R) under fasting conditions was preliminarily evaluated, and the rationality of the design of the formal trial administration method and operation process, sampling volume, blood collection time point, sample size, and administration dosage was provided. At the same time, the safety of the drug in healthy subjects was investigated.

Primary objective: This study used palbociclib capsules (trade name: Iboxin®) imported by Pfizer Europe MA EEIG as the reference preparation, and compared it with palbociclib capsules (test preparation) produced by Jiangxi Aishite Pharmaceutical Co., Ltd. to conduct a human bioequivalence test under fasting/postprandial conditions to evaluate the pharmacokinetics and bioequivalence of the test preparation and the reference preparation in healthy subjects. Secondary objective: To observe the safety of the test preparation and the reference preparation in healthy subjects.