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

• Status: Completed
• Trial end date: 2009-04-01
• 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.

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.

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

Details

• Lead Sponsor: RDD Pharma Ltd
• Treatments: Nifedipine

Criteria

Inclusion Criteria:

Subjects meeting the following criteria will be eligible to participate in the trial:

• Signed written informed consent;

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

Exclusion Criteria:

Subjects are excluded from participation in the study if any of the following criteria apply:

Has a clinically significant history or presence of any of the following conditions:

• Known allergy to Nifedipine, polyethylene-glycol, Propylene-glycol or silicone.

• Active or past history of disease that requires medication or clinical follow up.

• Malignant disease within 5 years of screening;

• History of ano rectal disease.

• History of gastrointestinal disease.

• History of gastrointestinal bleeding.

• History of rectal surgery.

• History of gastrointestinal surgery.

• History of HIV.

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

• Currently uses medication for acute illness.

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

• Has received any investigational drug within 90 days of screening;

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