[Translation] Randomized, open-label, single-dose, two-sequence, two-period, double-crossover bioequivalence study of clindamycin palmitate granules in Chinese healthy subjects under fasting and fed administration conditions
按有关生物等效性试验的规定,选择Pharmacia and Upjohn Co为持证商的盐酸克林霉素棕榈酸酯颗粒(商品名:Cleocin Pediatric®,规格:按克林霉素(C18H33ClN2O5S)计75mg/5ml)为参比制剂,对海南海神同洲制药有限公司生产的受试制剂盐酸克林霉素棕榈酸酯颗粒(规格: 75mg/5ml(按C18H33ClN2O5S计))进行空腹和餐后给药人体生物等效性试验,比较受试制剂中药物的吸收速度和吸收程度与参比制剂的差异是否在可接受的范围内,评价两种制剂在空腹和餐后给药条件下的生物等效性。
[Translation] According to the relevant bioequivalence test regulations, Pharmacia and Upjohn Co were selected as the licensee's clindamycin hydrochloride palmitate granules (trade name: Cleocin Pediatric®, specification: 75mg/ 5ml) as the reference preparation, the test preparation clindamycin hydrochloride palmitate granules (specification: 75mg/5ml (calculated as C18H33ClN2O5S)) produced by Hainan Haishen Tongzhou Pharmaceutical Co., Ltd. was administered to human biological The equivalence test compares whether the difference between the absorption rate and absorption degree of the drug in the test preparation and the reference preparation is within an acceptable range, and evaluates the bioequivalence of the two preparations under fasting and postprandial administration conditions.