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.

Start Date05 Dec 2019

Sponsor / Collaborator

McNeil AB

NCT00807326 / CompletedPhase 4

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.

Start Date01 Nov 2008

Sponsor / Collaborator

McNeil AB

NCT00685607 / CompletedPhase 4

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.

Start Date01 Oct 2008

Sponsor / Collaborator

Johnson & Johnson Consumer and Personal Products Worldwide

100 Clinical Results associated with Loperamide Hydrochloride/Dimethicone

100 Translational Medicine associated with Loperamide Hydrochloride/Dimethicone

100 Patents (Medical) associated with Loperamide Hydrochloride/Dimethicone

Literatures (Medical) associated with Loperamide Hydrochloride/Dimethicone

01 Jul 2001·European Journal of Pharmaceutical SciencesQ2 · MEDICINE

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

Q2 · MEDICINE

Article

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

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 Deals associated with Loperamide Hydrochloride/Dimethicone

R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Abdomen distended	US	Johnson & Johnson Holdco (NA), Inc.	30 Nov 2000
Diarrhea	US	Johnson & Johnson Holdco (NA), Inc.	26 Jun 1997
Gastrointestinal spasm	US	Johnson & Johnson Holdco (NA), Inc.	26 Jun 1997

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