Parikh R, Sweetland J, Forster E R, Bedding A W, Farr S J, Smith J T
Division of Clinical Pharmacology, Glaxo Research and Development Ltd, Greenford, Middlesex.
Br J Clin Pharmacol. 1994 Dec;38(6):577-80. doi: 10.1111/j.1365-2125.1994.tb04400.x.
Ranitidine bismuth citrate, a new chemical entity which is a salt complex of ranitidine and bismuth citrate, is being developed for the treatment of relapse of benign gastric and duodenal ulcer and eradication of Helicobacter pylori. The aim of the present study was to establish whether ranitidine bismuth citrate (800 mg) or ranitidine hydrochloride (300 mg) have any effect on gastric emptying of a liquid meal using gamma scintigraphy. On three separate occasions, each of twelve subjects received a single oral tablet of 800 mg ranitidine bismuth citrate, 300 mg ranitidine hydrochloride or placebo in random order. Thirty minutes after dosing each subject was given 375 ml of 99mTc-DTPA (diethylene triaminepentaacetic acid) labelled Clinifeed-ISO. The primary endpoint was the time to 50% gastric emptying (t50%). The proportion of the meal remaining was summarised by weighted mean proportion of the meal remaining in the stomach over 0-60 min and 0-180 min, separately. No differences were observed for t50%, weighted mean 0-60 min, and weighted mean 0-180 min between any two treatments. In man, we have detected no significant effect of single oral doses of ranitidine bismuth citrate 800 mg or ranitidine hydrochloride 300 mg on the rate of gastric emptying of a liquid meal when compared with placebo.
枸橼酸雷尼替丁铋,一种新的化学实体,是雷尼替丁与枸橼酸铋的盐复合物,正被开发用于治疗良性胃及十二指肠溃疡的复发以及根除幽门螺杆菌。本研究的目的是使用γ闪烁扫描术确定枸橼酸雷尼替丁(800毫克)或盐酸雷尼替丁(300毫克)对流食餐胃排空是否有任何影响。在三个不同的时间段,12名受试者每人随机依次接受一片800毫克枸橼酸雷尼替丁、300毫克盐酸雷尼替丁或安慰剂口服片剂。给药30分钟后,给每位受试者服用375毫升用99mTc-DTPA(二乙三胺五乙酸)标记的Clinifeed-ISO。主要终点是达到50%胃排空的时间(t50%)。通过分别计算0至60分钟和0至180分钟内胃内剩余餐食的加权平均比例来总结剩余餐食的比例。在任何两种治疗之间,未观察到t50%、0至60分钟加权平均值和0至180分钟加权平均值有差异。在人体中,与安慰剂相比,我们未检测到单次口服800毫克枸橼酸雷尼替丁或300毫克盐酸雷尼替丁对流食餐胃排空速率有显著影响。