Shanxi Taiyuan Pharmaceutical Co. Ltd.

Main study objectives: Through fasting/postprandial test studies, the in vivo pharmacokinetic characteristics of the test preparation ibuprofen tablets (specification: 0.2 g, produced by Shanxi Taiyuan Pharmaceutical Co., Ltd.) and the reference preparation ibuprofen tablets (trade name: Motrin IB®, specification: 0.2 g, licensed by Perrigo R AND D, produced by JOHNSON AND JOHNSON CONSUMER INC MCNEIL CONSUMER HEALTHCARE DIV) were investigated in healthy Chinese subjects after a single oral administration under fasting/postprandial conditions, and the bioequivalence of the two preparations was evaluated. Secondary study objectives: To evaluate the safety of a single oral administration of 0.2 g of the test preparation and the reference preparation of ibuprofen tablets in healthy Chinese subjects.

Main research purpose: According to the relevant provisions of bioequivalence test, the norfloxacin tablets (trade name: BACCIDAL®, specification: 0.1g/tablet) of Kyorin Pharmaceutical Co., Ltd. were selected as the reference preparation, and the test preparation norfloxacin capsules (specification: 0.1g/tablet) produced by Shanxi Taiyuan Pharmaceutical Co., Ltd. were conducted on the human bioequivalence test of fasting 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 evaluate the bioequivalence of the two preparations under fasting administration conditions. Secondary research purpose: To observe the safety of oral administration of the test preparation norfloxacin capsules (specification: 0.1g/tablet) and the reference preparation norfloxacin tablets (trade name: BACCIDAL®, specification: 0.1g/tablet) by healthy volunteers.

Main research purpose: According to the relevant provisions of bioequivalence test, the norfloxacin tablets (trade name: BACCIDAL®, specification: 0.1g/tablet) of Kyorin Pharmaceutical Co., Ltd. were selected as the reference preparation, and the test preparation norfloxacin capsules (specification: 0.1g/tablet) produced by Shanxi Taiyuan Pharmaceutical Co., Ltd. were used for fasting human bioequivalence preliminary test, and the pharmacokinetic characteristics of norfloxacin after fasting administration were estimated, so as to provide a certain reference basis for the design of formal tests. Secondary research purpose: To observe the safety of healthy volunteers taking the test preparation norfloxacin capsules (specification: 0.1g/tablet) and the reference preparation norfloxacin tablets (trade name: BACCIDAL®, specification: 0.1g/tablet) orally.