A Bioequivalence Study of Two Different Dosages of Isoniazid Tablet Formulations in Human Healthy Volunteers
Status:
Completed
Trial end date:
2009-03-01
Target enrollment:
Participant gender:
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.