Hainan Haishen Tongzhou Pharmaceutical Co Ltd.

Primary objective: To evaluate the bioequivalence of the two in healthy subjects in fasting and postprandial states, using the arginine ibuprofen granules (specification: 0.4g (in terms of ibuprofen)) produced by Hainan Haishen Tongzhou Pharmaceutical Co., Ltd. as the test preparation and the arginine ibuprofen granules (trade name: Spedex® specification: 0.4g (in terms of ibuprofen)) produced by Hainan Zanbang Pharmaceutical Co., Ltd. as the reference preparation according to the relevant bioequivalence regulations. Secondary objective: To observe the safety of the test preparation and the reference preparation in healthy subjects.

Primary objective: To evaluate the bioequivalence of acetylcysteine granules (specification: 0.2 g) produced by Hainan Haishen Tongzhou Pharmaceutical Co., Ltd. as the test preparation and acetylcysteine granules (trade name: Fulushi® specification: 0.2 g) produced by Hainan Zanbang Pharmaceutical Co., Ltd. as the reference preparation in healthy subjects in fasting and postprandial states according to relevant bioequivalence regulations. Secondary objective: To observe the safety of the test preparation and the reference preparation in healthy subjects.

In accordance with the relevant provisions of bioequivalence tests, clindamycin palmitate hydrochloride granules (trade name: Cleocin Pediatric®, specification: 75 mg/5 ml calculated as clindamycin (C18H33ClN2O5S)) produced by Pharmacia and Upjohn Co was selected as the reference preparation, and a human bioequivalence study of postprandial administration was conducted on the test preparation clindamycin palmitate hydrochloride granules (specification: 5 ml: 75 mg (calculated as C18H33ClN2O5S)) produced by Hainan Haishen Tongzhou Pharmaceutical Co., Ltd. was conducted to compare whether the absorption rate and degree of the drug in the test preparation were within an acceptable range with those of the reference preparation, and to evaluate the bioequivalence of the two preparations under postprandial administration conditions.