Tuberculosis Clinical Trial
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
Verified date | January 2014 |
Source | Oswaldo Cruz Foundation |
Contact | n/a |
Is FDA regulated | No |
Health authority | Brazil: Ethics Committee |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 28 |
Est. completion date | March 2009 |
Est. primary completion date | October 2008 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 50 Years |
Eligibility |
Inclusion Criteria: - healthy men and women - aged between 18 and 50 years - BMI between 18.5 and 29.9 kg/m² |
Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Brazil | Synchrophar - Ass. e Desenv. de Projetos Clínicos Ltda. | Campinas | São Paulo |
Lead Sponsor | Collaborator |
---|---|
Oswaldo Cruz Foundation |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Average bioequivalence based on the 90% CI | 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 | Yes |
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