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

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;