Hainan Hailing Chemipharma Corp. Ltd.

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.

In accordance with the relevant provisions of bioequivalence tests, Ciliborole Ointment (trade name: Sutanming, specification: 2%) produced by Anacor Pharmaceuticals, Inc. was selected as the reference preparation, and the test preparation Ciliborole Ointment (specification: 2% (30g: 0.6g)) provided by Hainan Hailing Chemical Pharmaceutical Co., Ltd. was subjected to a human bioequivalence test for external administration on an empty stomach. The absorption rate and degree of the drug in the test preparation were compared with those of the reference preparation to see whether they were within an acceptable range, and the bioequivalence of the two preparations under the conditions of external administration on an empty stomach was evaluated.