[Translation] Randomized, open-label, single-dose, two-formulation, two-sequence, two-cycle, double-crossover bioequivalence trial of ibuprofen suspension in Chinese healthy subjects under fasting and postprandial administration conditions
主要研究目的:按有关生物等效性试验的规定,选择上海强生制药有限公司为持证商的布洛芬混悬液(商品名:美林,规格:100mL:2g)为参比制剂,对湖北亨迪药业股份有限公司持证、湖北唯森制药有限公司生产的受试制剂布洛芬混悬液(规格:30mL:0.6g)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。
次要研究目的:观察健康受试者口服10mL(0.2g)受试制剂布洛芬混悬液(规格:30mL:0.6g)和10mL(0.2g)参比制剂布洛芬混悬液(商品名:美林,规格:100mL:2g)的安全性
[Translation] Main research purpose: According to the regulations on bioequivalence testing, Ibuprofen suspension (trade name: Merrill Lynch, specification: 100mL:2g) of Shanghai Johnson & Johnson Pharmaceutical Co., Ltd. is selected as the reference preparation. The test preparation ibuprofen suspension (specification: 30mL:0.6g), which is licensed by Hubei Hengdi Pharmaceutical Co., Ltd. and produced by Hubei Weisen Pharmaceutical Co., Ltd., has been tested for human bioequivalence after fasting and postprandial administration. Compare the absorption rate and extent of the drug in the test preparation with the reference preparation to see if the difference is within the acceptable range, and evaluate the bioequivalence of the two preparations under fasting and postprandial administration conditions.
Secondary research purpose: To observe the oral administration of 10 mL (0.2 g) of the test preparation ibuprofen suspension (specification: 30 mL: 0.6 g) and 10 mL (0.2 g) of the reference preparation ibuprofen suspension (commercial product) to healthy subjects. Name: Merrill Lynch, specifications: 100mL:2g) safety