drugset
drugset / Trial / NCT01834742

Pharmacodynamic Evaluation of Stool Output Following Oral Administration of Various Low Volume PEG3350-based Gut Cleansing Solutions Using the Split Dose Intake in Healthy Subjects

NCT01834742 ↗

Phase 1 Completed 161 enrolled Norgine Pierrel Research Europe GmbH · collab
RandomizedParallel-groupOpen-labelTreatment

Summary

This study is to investigate the effect of various modified low volume polyethylene glycol (PEG) 3350 and ascorbic acid/ascorbate (PEG+ASC)-based gut cleansing solutions on stool output in healthy subjects. In addition, the study is to assess and compare the safety and tolerance of the modified PEG+ASC formulations following oral administration with the safety profile of MOVIPREP®.

Timeline

Start
2011-04
Primary completion
2011-09
Completion
2011-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator Moviprep Other / unclassified 1000 ml Oral
Subject polyethylene glycol Other / unclassified 750 ml Oral
Subject polyethylene glycol Other / unclassified 4.8 g Oral
Subject polyethylene glycol Other / unclassified 5.6 g Oral
Subject polyethylene glycol Other / unclassified 6 g Oral
Subject polyethylene glycol Other / unclassified 9 g Oral
Subject polyethylene glycol Other / unclassified 20.1 g Oral
Subject polyethylene glycol Other / unclassified 21.4 g Oral
Subject polyethylene glycol Other / unclassified 23.3 g Oral
Subject polyethylene glycol Other / unclassified 29 g Oral
Subject polyethylene glycol Other / unclassified 33.9 g Oral
Subject polyethylene glycol Other / unclassified 40 g Oral
Subject polyethylene glycol Other / unclassified 56.6 g Oral
Subject polyethylene glycol Other / unclassified 75 g Oral
Subject polyethylene glycol Other / unclassified 100 g Oral

Indications

colorectal cancer