drugset / Trial / NCT00972998

Study to Examine the Effect of Coated Phenylephrine Suppositories on Anal Pressure in Healthy Subjects

NCT00972998

Phase 1/2 Completed 8 enrolled RDD Pharma Ltd
NaSingle-groupOpen-label

Summary

This is an open label, dose-finding study. Approximately 8 healthy subjects will be participating in this study. A screening will be used to determine subject suitability for inclusion in the trial. 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 Phenylephrine suppositories at various doses) will be administered at pre-determined intervals.

Timeline

Start
2009-09
Primary completion
2009-12
Completion
2009-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Phenylephrine Small molecule 40 mg Rectal
Subject Phenylephrine Small molecule 80 mg Rectal

Indications

No indication recorded.