Hainan Hailing Chemipharma Corp. Ltd.

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.

This study aimed to investigate the pharmacokinetic characteristics of faropenem sodium tablets (200 mg) developed and produced by Hainan Hailing Chemical Pharmaceutical Co., Ltd. after single fasting and postprandial oral administration in healthy subjects; Faropenem sodium tablets (Farom®, 200 mg) licensed and produced by Maruho Co., Ltd were used as the reference preparation, and the pharmacokinetic parameters Cmax, AUC0-t, and AUC0-∞ of the two preparations were compared to evaluate the bioequivalence of the two preparations in humans.

The main purpose of this study is to evaluate the pharmacokinetic differences of Hemay 005 tablets in subjects with mild, moderate renal impairment and normal renal function, and to provide a basis for formulating clinical medication plans for patients with renal impairment.