Hainan Haishen Tongzhou Pharmaceutical Co Ltd.

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.

Primary objective: To evaluate the bioequivalence of loratadine tablets (10 mg) produced by Hainan Haishen Tongzhou Pharmaceutical Co., Ltd. with the reference preparation, using loratadine tablets (10 mg) produced by Bayer Pharmaceuticals (Shanghai) Co., Ltd. (trade name: Claritin) as the reference preparation. Secondary objective: To evaluate the safety of loratadine tablets produced by Hainan Haishen Tongzhou Pharmaceutical Co., Ltd.

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 the test preparation clindamycin palmitate hydrochloride granules (specification: 75 mg/5 ml (calculated as C18H33ClN2O5S)) produced by Hainan Haishen Tongzhou Pharmaceutical Co., Ltd. was subjected to a human bioequivalence study on fasting and fed administration. The differences in the absorption rate and extent of the drug in the test preparation and the reference preparation were compared to see whether they were within an acceptable range, and the bioequivalence of the two preparations under fasting and fed administration conditions was evaluated.