Hainan Hailing Chemipharma Corp. Ltd.

The pharmacokinetics of the test preparation finerenone tablets (specification: 10 mg, produced by Hainan Hailing Chemical Pharmaceutical Co., Ltd.) and the reference preparation finerenone tablets (Kerendia®, specification: 10 mg, produced by Bayer AG) were studied in healthy participants after single oral administration in fasting and fed states, and the bioequivalence of the two preparations after oral administration in fasting and fed states was evaluated.

Main study purpose: According to the relevant provisions of bioequivalence test, oseltamivir phosphate capsules (trade name: Tamiflu®, specification: 75 mg calculated by C16H28N2O4) with Roche Pharma (Schweiz) AG as the licensee were selected as the reference preparation, and the human bioequivalence test of the test preparation oseltamivir phosphate capsules (specification: 75 mg (calculated by C16H28N2O4)) provided by Hainan Hailing Chemical Pharmaceutical Co., Ltd. was conducted to evaluate the bioequivalence of the two preparations under fasting conditions. Secondary study purpose: To observe the safety of oral administration of the test preparation oseltamivir phosphate capsules (specification: 75 mg (calculated by C16H28N2O4)) and the reference preparation oseltamivir phosphate capsules (trade name: Tamiflu®, specification: 75 mg calculated by C16H28N2O4) in healthy subjects.

The main purpose of the study was to use the vonoprazan fumarate tablets (specification: 20 mg) developed by Hainan Hailing Chemical Pharmaceutical Co., Ltd. as the test preparation. According to the relevant provisions of the bioequivalence study, the relative bioavailability in healthy humans was compared with the vonoprazan fumarate tablets (specification: 20 mg, reference preparation, trade name: Vocinti®) licensed by Takeda Pharmaceutical Company Limited to investigate the human bioequivalence of the two preparations. Secondary purpose of the study was to observe the safety of the test preparation and reference preparation (trade name: Vocinti®) of vonoprazan fumarate tablets in healthy subjects.