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

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ClinicalTrials.gov Identifier: NCT02043314
Recruitment Status : Completed
First Posted : January 23, 2014
Last Update Posted : January 23, 2014
Information provided by (Responsible Party):
Oswaldo Cruz Foundation

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Tuberculosis Drug: Isoniazida Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: New Strategy for Treating Latent Tuberculosis Infection in Brazil: A Bioequivalence Study of Two Different Dosages of Isoniazid Tablet Formulations in Human Healthy Volunteers
Study Start Date : October 2008
Actual Primary Completion Date : October 2008
Actual Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tuberculosis
Drug Information available for: Isoniazid

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

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02043314

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Synchrophar - Ass. e Desenv. de Projetos Clínicos Ltda.
Campinas, São Paulo, Brazil, 13070-200
Sponsors and Collaborators
Oswaldo Cruz Foundation
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Principal Investigator: Eduardo W Barroso, Dr Fundação Oswaldo Cruz
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Responsible Party: Oswaldo Cruz Foundation
ClinicalTrials.gov Identifier: NCT02043314    
Other Study ID Numbers: 03.ISZ18-08BE.02
First Posted: January 23, 2014    Key Record Dates
Last Update Posted: January 23, 2014
Last Verified: January 2014
Additional relevant MeSH terms:
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Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Bacterial Infections and Mycoses
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Fatty Acid Synthesis Inhibitors
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents