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Pharmacokinetics Trial of Isosorbide Mononitrate 0.5% Gel for Intra Anal Application in Healthy Subjects

NCT04729088 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2021-02-01

No results posted yet for this study

Summary

This is a Phase I trial to evaluate pharmacokinetics and safety of Isosorbide Mononitrate gel for intra anal administration in healthy subjects.

Conditions

  • Pharmacokinetics
  • Healthy Subjects

Interventions

DRUG

Isosorbide mononitrate

Intra-anal application performed by the study physician of 2 g of the study drug

Sponsors & Collaborators

  • Biolab Sanus Farmaceutica

    lead INDUSTRY

Principal Investigators

  • José Pedrazzoli Jr., MD · CAEP - Centro Avançado de Estudos e Pesquisas Ltda.

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-12-20
Primary Completion
2020-12-20
Completion
2020-12-20

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04729088 on ClinicalTrials.gov