Clinical Trial: An Open-Label, Single- and Multi-Dose Pharmacokinetic (PK) Study of Oral Diltiazem and Topical Diltiazem Hydrochloride
Study Status: Withdrawn
Recruit Status: Unknown status
Study Type: Interventional
Official Title: An Open-Label, Single- and Multi-Dose Pharmacokinetic (PK) Study of Oral Diltiazem and Topical Diltiazem Hydrochloride
Brief Summary: The study is a single-center, open-label, safety and pharmacokinetic study in12 adult subjects with Anal Fissures. Subjects will be screened to determine eligibility within 7 days of treatment. There will be three parts to the study and all subjects will participate in each part.
Detailed Summary:
Sponsor: Ventrus Biosciences, Inc
Current Primary Outcome: Single and multiple dose Pharmacokinetic parameters [ Time Frame: up to 6 months after enrollment begins ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Safety as determined by nature, severity and relationship of adverse events, clinical labs, physical exam findings, vital signs and Electrocardiogram [ Time Frame: Up to 6 months after enrollment begins ]
Original Secondary Outcome: Same as current
Information By: Ventrus Biosciences, Inc
Dates:
Date Received: March 13, 2013
Date Started: February 2013
Date Completion: September 2013
Last Updated: August 19, 2013
Last Verified: July 2013