drugset / Trial / NCT00816205

An Open Label Study to Examine the Effect of Coated Nifedipine Suppositories on Anal Pressure in Healthy Subjects

NCT00816205

Phase 1/2 Completed RDD Pharma Ltd
NaSingle-group

Summary

This is an open label, dose-finding study. Approximately 8 healthy subjects will be participating in this study. Within one week after the screening visit, subjects who meet all inclusion criteria and none of the exclusion criteria will enter a one day treatment period. During this period, 4 anal manometric studies will take place. Study medication (Coated Nifedipine suppositories at various doses) will be administered at pre-determined intervals. During the study, blood samples will be obtained for plasma Nifedipine analysis.

Timeline

Start
Primary completion
Completion
2009-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Nifedipine Other / unclassified 24 mg Rectal

Indications

No indication recorded.