[Translation] A single-center, randomized, open-label, single-dose, two-formulation, two-sequence, four-period, fully repeated crossover bioequivalence study of mesalazine enema solution in healthy volunteers
主要目的
比较山东睿亿医药有限公司提供的美沙拉秦灌肠液(60g:4g)与Dr. Falk Pharma GmbH持证的美沙拉秦灌肠液(60g:4g,商品名:莎尔福)在健康成年人群中吸收程度和速度的差异,评价其生物等效性。
次要目的
评价山东睿亿医药有限公司提供的美沙拉秦灌肠液(60g:4g)与Dr. Falk Pharma GmbH持证的美沙拉秦灌肠液(60g:4g,商品名:莎尔福)在健康成年人群中的安全性。
[Translation] Primary objective
To compare the differences in absorption extent and rate between mesalazine enema solution (60g:4g) provided by Shandong Ruiyi Pharmaceutical Co., Ltd. and mesalazine enema solution (60g:4g, trade name: Salfo) certified by Dr. Falk Pharma GmbH in healthy adults, and to evaluate their bioequivalence.
Secondary objective
To evaluate the safety of mesalazine enema solution (60g:4g) provided by Shandong Ruiyi Pharmaceutical Co., Ltd. and mesalazine enema solution (60g:4g, trade name: Salfo) certified by Dr. Falk Pharma GmbH in healthy adults.