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

• Status: Completed
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: RDD Pharma Ltd
• Treatments: Oxymetazoline; Phenylephrine

Criteria

Inclusion Criteria:

• Signed written informed consent.

• Male or female subjects 18 to 55 years of age.

Exclusion Criteria:

• Active or chronic disease.

• In need of chronic use of medication, with the exception of birth control medications.

• Currently uses medication for acute illness.

• Has used, in the last four weeks, drugs that may affect blood coagulation, such as Aspirin, Warfarin, Sintrom, Enoxaparin, Nadroparin, Heparin, Clopidogrel, Ticlopidine.

• Has upon physical examination a rectal deformation or signs of rectal disease such as fissure, bleeding hemorrhoids, fistula., infection or space occupying lesion.

• Receipt of any investigational treatment (drug or device) within 90 days prior to screening.