A Bioequivalence Study of Two Different Dosages of Isoniazid Tablet Formulations in Human Healthy Volunteers
NCT ID: NCT02043314
Last Updated: 2014-01-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
28 participants
INTERVENTIONAL
2008-10-31
2009-03-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Isoniazida-LAQFA®
3 coated tablet of 100mg
Isoniazida
Isoniazida
coated tablet of 300mg
Isoniazida
Interventions
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Isoniazida
Eligibility Criteria
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Inclusion Criteria
* aged between 18 and 50 years
* BMI between 18.5 and 29.9 kg/m²
18 Years
50 Years
ALL
Yes
Sponsors
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Oswaldo Cruz Foundation
OTHER
Responsible Party
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Principal Investigators
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Eduardo W Barroso, Dr
Role: PRINCIPAL_INVESTIGATOR
Fundação Oswaldo Cruz
Locations
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Synchrophar - Ass. e Desenv. de Projetos Clínicos Ltda.
Campinas, São Paulo, Brazil
Countries
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Other Identifiers
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03.ISZ18-08BE.02
Identifier Type: -
Identifier Source: org_study_id
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