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KE, L-Lys-L-Glu, lysylglutamic acid

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Studies 40
Trials 100
Withdrawn PHASE1 INTERVENTIONAL NCT02667535

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

View on ClinicalTrials.gov Updated Dec 15, 2025

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 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.

Interventions

Name: Isosorbide Mononitrate
Type: DRUG
Description: 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.

Primary Outcomes

Measure: Pharmacokinetics, area under the curve time zero - last (AUC t0-last)
TimeFrame: 7 days
Description:
Measure: Pharmacokinetics, area under the curve time zero - infinite (AUC t0-inf)
TimeFrame: 7 days
Description:
Measure: Pharmacokinetics, constant of elimination (Ke)
TimeFrame: 7 days
Description:
Measure: Pharmacokinetics, half-life (t1/2)
TimeFrame: 7 days
Description:

Trial Information

NCT ID

NCT02667535

Status

Withdrawn

Study Type

INTERVENTIONAL

Phases

PHASE1

Sponsor

Biolab Sanus Farmaceutica

Last Updated

December 15, 2025