/ Active, not recruitingNot Applicable 盐酸丙卡特罗颗粒在健康受试者中单中心、开放、随机、单剂量、双周期、双交叉空腹和餐后状态下的生物等效性试验
[Translation] A single-center, open-label, randomized, single-dose, two-period, double-crossover bioequivalence study of Procaterol Hydrochloride Granules in healthy subjects under fasting and fed conditions
主要目的
比较空腹和餐后给药条件下,黑龙江龙德药业有限公司提供的盐酸丙卡特罗颗粒(1g:50μg)与大塚製薬株式会社持证的盐酸丙卡特罗干糖浆(商品名:Meptin®,规格:0.005%)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
评价空腹和餐后给药条件下,黑龙江龙德药业有限公司提供的盐酸丙卡特罗颗粒(1g:50μg)与大塚製薬株式会社持证的盐酸丙卡特罗干糖浆(商品名:Meptin®,规格:0.005%)在健康成年人群中的安全性。
[Translation] main purpose
Comparing the conditions of fasting and postprandial administration, Procaterol Hydrochloride Granules (1g:50μg) provided by Heilongjiang Longde Pharmaceutical Co., Ltd. and Procaterol Hydrochloride Dry Syrup (Trade Name: Meptin®) certified by Otsuka Manufacturing Co., Ltd. , Specification: 0.005%) in healthy adults, the degree and rate of absorption are different, and its bioequivalence is evaluated.
secondary purpose
To evaluate the conditions of fasting and postprandial administration, Procaterol Hydrochloride Granules (1g:50μg) provided by Heilongjiang Longde Pharmaceutical Co., Ltd. and Procaterol Hydrochloride Dry Syrup (trade name: Meptin®) certified by Otsuka Manufacturing Co., Ltd. , specification: 0.005%) safety in healthy adults.
100 Clinical Results associated with Heilongjiang Longde Pharmaceutical Co., Ltd.
0 Patents (Medical) associated with Heilongjiang Longde Pharmaceutical Co., Ltd.
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100 Translational Medicine associated with Heilongjiang Longde Pharmaceutical Co., Ltd.