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An Open-Label, Single- and Multi-Dose Pharmacokinetic (PK) Study of Oral Diltiazem and Topical Diltiazem Hydrochloride
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.
Details
| Lead sponsor | Ventrus Biosciences, Inc |
|---|---|
| Phase | Phase 1 |
| Status | UNKNOWN |
| Enrolment | 12 |
| Start date | 2013-02 |
| Completion | 2013-09 |
Conditions
- Adult Subjects With Anal Fissures.
Interventions
- Diltiazem Hydrochloride Cream and Oral Diltiazem
Primary outcomes
- Single and multiple dose Pharmacokinetic parameters — up to 6 months after enrollment begins
Single- and multiple-dose PK parameters for topical DTZ and single-dose PK parameters for oral DTZ including AUC(0-t), AUC(0-∞), Cmax, tmax, t1/2 and CL/F. PK parameters for DTZ, and its two metabolites (N-desmethylditiazem and O-desacetyldiltiazem) will be presented in Data Listings and summarized by Day (Study Day 1, 7 and 14). Descriptive statistics will include n, mean, SD, %CV, geometric mean,median, minimum, and maximum.
Countries
United States