drugset / Trial / NCT01596777

Effects of 500 mg Immediate Release and Extended Release Methylnaltrexone on Loperamide-induced Delay of the Oro-cecal and Whole-gut Transit Time in Healthy Subjects

NCT01596777

Phase 1 Completed 15 enrolled University Medicine Greifswald
RandomizedCrossoverTriple-blindBasic science

Summary

The purpose of this study is to describe the effects of methylnaltrexone in preventing loperamide-induced delay of the oro-cecal and whole-gut transit time and measure pharmacokinetics of methylnaltrexone after subcutaneous and oral administration of immediate release and extended release capsules.

Timeline

Start
2010-01
Primary completion
2010-03
Completion
2010-05

Drugs

EvaluationDrugModalityDoseRoute
Comparator Loperamide Small molecule
Comparator Methylnaltrexone Other / unclassified 12 mg Subcutaneous
Comparator Methylnaltrexone Other / unclassified 500 mg Subcutaneous
Comparator Sulfasalazine Small molecule 500 mg