Nantong Jiuhe Medicine Co. Ltd.

Main research purpose: According to the relevant provisions of bioequivalence test, azithromycin dry suspension (trade name: Xishumei®, specification: 0.1g/bag) produced by Pfizer Pharmaceuticals Co., Ltd. was selected as the reference preparation, and the test preparation azithromycin dry suspension (specification: 0.1g/bag) produced by Nantong Jiuhe Pharmaceutical Co., Ltd. was subjected to a human bioequivalence test after meal administration. 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 condition of postprandial administration was compared.

Main research purpose: According to the relevant provisions of bioequivalence test, azithromycin dry suspension (trade name: Xishumei®, specification: 0.1g/bag) produced by Pfizer Pharmaceuticals Co., Ltd. was selected as the reference preparation, and the test preparation azithromycin dry suspension (specification: 0.1g/bag) produced by Nantong Jiuhe Pharmaceutical Co., Ltd. was subjected to human bioequivalence test on fasting and postprandial administration, to compare whether the absorption rate and degree of the drug in the test preparation were within the acceptable range with the reference preparation, and to compare the bioequivalence of the two preparations under fasting and postprandial administration conditions. Secondary research purpose: To observe the safety of oral administration of the test preparation azithromycin dry suspension (specification: 0.1g/bag) and the reference preparation azithromycin dry suspension (trade name: Xishumei®, specification: 0.1g/bag) in healthy volunteers.

In accordance with the relevant provisions of bioequivalence tests, azithromycin dry suspension (trade name: Zithromax®, specification: 0.1g/bag) produced by Pfizer Pharmaceuticals Co., Ltd. was selected as the reference preparation. The test preparation azithromycin dry suspension (specification: 0.1g/bag) produced by Nantong Jiuhe Pharmaceutical Co., Ltd. was subjected to a preliminary human bioequivalence test on fasting and fed administration. The pharmacokinetic characteristics of the test preparation and the reference preparation after fasting and fed administration were estimated, providing a certain reference basis for the design of the formal test.