[Translation] A single-center, randomized, open-label, single-dose, two-sequence, four-period, fully repeated crossover bioequivalence study of mesalazine suppositories in healthy volunteers under fasting conditions
主要目的
比较空腹给药条件下,黑龙江龙德药业有限公司提供的美沙拉秦栓(0.5g)与Dr. Falk Pharma GmbH持证的美沙拉秦栓(0.5g,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
评价空腹给药条件下,黑龙江龙德药业有限公司提供的美沙拉秦栓(0.5g)与Dr. Falk Pharma GmbH持证的美沙拉秦栓(0.5g,商品名:莎尔福)在健康成年人群中的安全性。
[Translation] Primary Objective
To compare the extent and rate of absorption of mesalamine suppositories (0.5g) provided by Heilongjiang Longde Pharmaceutical Co., Ltd. and mesalamine suppositories (0.5g, trade name: Salfo) licensed by Dr. Falk Pharma GmbH in healthy adults under fasting conditions and to evaluate their bioequivalence.
Secondary Objective
To evaluate the safety of mesalamine suppositories (0.5g) provided by Heilongjiang Longde Pharmaceutical Co., Ltd. and mesalamine suppositories (0.5g, trade name: Salfo) licensed by Dr. Falk Pharma GmbH in healthy adults under fasting conditions.