NCT02667535

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

Pharmacokinetics, Pharmacodynamics and Safety Comparative Trial of Isosorbide Mononitrate Gel in Participants With Anal Fissure and Healthy Volunteers.

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Biolab Sanus Farmaceutica · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

This is a Phase I, open-label, parallel trial to evaluate Pharmacokinetics, Pharmacodynamics and Safety of Isosorbide Mononitrate gel for usage in participants with anal fissure and healthy volunteers. Investigational product will be randomly assigned as follows: * healthy volunteers will receive 2g (2.0%) of investigational product at a single dose, and will undergo a washout period of 7 days; subsequently, they will receive 2g of investigational product once daily, for 7 consecutive days; * participants with anal fissure will receive 2g of investigational product, either at 0.5%, 1.0% or 2.0%, at a single dose, and will undergo a washout period of 7 days; subsequently, they will receive 2g of investigational product, either at 0.5%, 1.0% or 2.0%, once daily, for 7 consecutive days.

Conditions

• Anal Fissure

Interventions

Type	Name	Description
DRUG	Isosorbide Mononitrate	Healthy volunteers will receive 2g (2.0%) of investigational product at a single dose, and will undergo a washout period of 7 days; subsequently, they will receive 2g of investigational product once daily, for 7 consecutive days. Participants with anal fissure will receive 2g of investigational product, either at 0.5%, 1.0% or 2.0%, at a single dose, and will undergo a washout period of 7 days; subsequently, they will receive 2g of investigational product, either at 0.5%, 1.0% or 2.0%, once daily, for 7 consecutive days.

Timeline

• Start date: 2017-07-01
• Primary completion: 2017-10-01
• Completion: 2017-11-01
• First posted: 2016-01-29
• Last updated: 2017-07-17