A Bioequivalence Study of Two Different Dosages of Isoniazid Tablet Formulations in Human Healthy Volunteers

January 22, 2014 updated by: Oswaldo Cruz Foundation

New Strategy for Treating Latent Tuberculosis Infection in Brazil: A Bioequivalence Study of Two Different Dosages of Isoniazid Tablet Formulations in Human Healthy Volunteers

The recommended treatment for latent tuberculosis infection for adults is a daily dose of isoniazid 300mg during 6 months. In Brazil, isoniazid was formulated as 100 mg tables. The treatment duration and the high pill burden compromised patient adherence to the treatment. The Brazilian National Programme for Tuberculosis requested the development of a new 300mg isoniazid formulation. The aim of the study is to compare the bioavailability of the isoniazid 300mg new formulation and three 100mg tablets of the reference formulation.

The study is a randomized, single dose, open label, fasting, two-phase crossover bioequivalence study with a wash out period of 7 days (>7 half-life) in 28 healthy human volunteers. For the determination of isoniazid in human plasma, the investigators developed and validated a sensitive, simple and rapid HPLC-MS/MS method.

This will support the strategy adopted by the Brazilian National Program for Tuberculosis for the treatment of latent tuberculosis. The new formulation will increase patients' adherence to the treatment and quality of life. Medical doctors in Brazil should become aware of the new formulation and the new treatment strategy in order to prescribe the right medication and avoid errors that could result in a high frequency of adverse events. Future research studies should evaluate pharmacovigilance, acceptability of the new tablet formulation and its impact on the cure rate.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • São Paulo
      • Campinas, São Paulo, Brazil, 13070-200
        • Synchrophar - Ass. e Desenv. de Projetos Clínicos Ltda.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • healthy men and women
  • aged between 18 and 50 years
  • BMI between 18.5 and 29.9 kg/m²

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Isoniazida-LAQFA®
3 coated tablet of 100mg
Drug: Isoniazida
Experimental: Isoniazida
coated tablet of 300mg
Drug: Isoniazida

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Average bioequivalence based on the 90% CI
Time Frame: up to 6 months
The 90% confidence interval for isoniazid log transformed Cmax and AUC0-t should be within the accepted bioequivalence range 80.00-125.00% for Cmax and AUC0-t of isoniazid.
up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oswaldo Cruz Foundation

Investigators

  • Principal Investigator: Eduardo W Barroso, Dr, Fundacao Oswaldo Cruz

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (Actual)

October 1, 2008

Study Completion (Actual)

March 1, 2009

Study Registration Dates

First Submitted

January 17, 2014

First Submitted That Met QC Criteria

January 22, 2014

First Posted (Estimate)

January 23, 2014

Study Record Updates

Last Update Posted (Estimate)

January 23, 2014

Last Update Submitted That Met QC Criteria

January 22, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 03.ISZ18-08BE.02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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