Overview

PK, PD and Safety Comparative Trial of Isosorbide Mononitrate Gel in Healthy Participants and With Anal Fissure

Status:
Withdrawn
Trial end date:
2017-11-01
Target enrollment:
Participant gender:
Summary
This is a Phase I trial to evaluate Pharmacokinetics, Pharmacodynamics and Safety of Isosorbide Mononitrate gel for usage in participants with anal fissure and healthy volunteers. Three doses will be used in patients with anal fissure (0.5%, 1.0% or 2.0%) and healthy volunteers will receive 2.0% dose. All treatment will last 7 days.
Phase:
Phase 1
Details
Lead Sponsor:
Biolab Sanus Farmaceutica
Treatments:
Isosorbide
Isosorbide Dinitrate
Isosorbide-5-mononitrate