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

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

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

Brief 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 Summary:

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.

Sponsor: Biolab Sanus Farmaceutica

Current Primary Outcome:

  • Pharmacokinetics, area under the curve time zero - last (AUC t0-last) [ Time Frame: 7 days ]
  • Pharmacokinetics, area under the curve time zero - infinite (AUC t0-inf) [ Time Frame: 7 days ]
  • Pharmacokinetics, constant of elimination (Ke) [ Time Frame: 7 days ]
  • Pharmacokinetics, half-life (t1/2) [ Time Frame: 7 days ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Safety, by number of adverse events [ Time Frame: 7 days ]
  • Safety, by blood pressure measurement [ Time Frame: 7 days ]
  • Anorectal muscle contractility, by anorectal manometry [ Time Frame: 7 days ]


Original Secondary Outcome: Same as current

Information By: Biolab Sanus Farmaceutica

Dates:
Date Received: January 26, 2016
Date Started: July 2017
Date Completion: November 2017
Last Updated: February 1, 2017
Last Verified: February 2017