An Open-label, Randomized, Fasting, Two-period, Single-dose, Crossover Study to Assess Bioequivalence Between a Combination Caplet With Loperamide Hydrochloride and Simethicone (Janssen-Cilag, France), and Imodium® Express Tablets-lyophilizate (Janssen-Cilag, France) Coadministered With Espumisan® Capsule (Berlin-Chemie AG, Germany), in Healthy Volunteers

The purpose of this study is to assess bioequivalence between a Combination caplet with loperamide hydrogen chloride (HCl) 2 milligram (mg) and simethicone 125 mg, and Imodium Express tablets-lyophilizate with loperamide HCl 2 mg (co-administered with Espumisan capsules with simethicone 40 mg), with respect to the single-dose pharmacokinetics of loperamide HCl. The maximum observed concentration (Cmax), and the area under the concentration-vs.-time curve until the last measurable concentration (AUC [0-t]) will be used to assess bioequivalence.

开始日期2019-12-05

申办/合作机构

McNeil AB

NCT00807326 / Completed临床4期

A Randomized, Parallel Group Comparison of Loperamide/Simeticone Caplet, Loperamide/Simeticone Chewable Tablet (IMODIUM® PLUS) and a Probiotic (Saccharomyces Boulardii) in the Treatment of Acute Diarrhea in Adults

A comparison of three medications to treat diarrhea in adults.

开始日期2008-11-01

申办/合作机构

McNeil AB

NCT00685607 / Completed临床4期

A Placebo-Controlled, Double-Blind, Randomized Pilot Study to Evaluate the Appropriateness of Multiple Endpoints in Measuring the Onset of Clinical Efficacy of Loperamide-Simethicone Caplets in the Treatment of Acute Non-specific Diarrhea

For six hours following drug administration, subjects will rate the severity of specific symptoms. At the end of the six hour study, subjects will rate the overall effectiveness of the product.

开始日期2008-10-01

申办/合作机构

Johnson & Johnson Consumer and Personal Products Worldwide

100 项与盐酸洛哌丁胺/二甲硅油相关的临床结果

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100 项与盐酸洛哌丁胺/二甲硅油相关的转化医学

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100 项与盐酸洛哌丁胺/二甲硅油相关的专利（医药）

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项与盐酸洛哌丁胺/二甲硅油相关的文献（医药）

2001-07-01·European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences2区 · 医学

A scintigraphic study to investigate the potential for altered gut distribution of loperamide from a loperamide–simethicone formulation in man

2区 · 医学

Article

作者: A.L Connor ; I.R Wilding ; H Wray ; J Cottrell

A loperamide simethicone combination formulation has recently been demonstrated to have significant clinical advantages compared to loperamide alone in the relief of diarrhoea and related symptoms. The product visualisation technique of gamma scintigraphy has been used to investigate the interaction of the formulation with the heterogenous environment of the human gut in a group of 12 healthy volunteers. The results suggest that changes in the intestinal kinetics of loperamide from the combination product, e.g. jejunal coating, could be contributing to the improved efficacy.

100 项与盐酸洛哌丁胺/二甲硅油相关的药物交易

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研发状态

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适应症	国家/地区	公司	日期
腹部膨胀	美国	Johnson & Johnson Holdco (NA), Inc.	2000-11-30
腹泻	美国	Johnson & Johnson Holdco (NA), Inc.	1997-06-26
胃肠痉挛	美国	Johnson & Johnson Holdco (NA), Inc.	1997-06-26
肌痛性痉挛	美国	Johnson & Johnson Holdco (NA), Inc.	1997-06-26