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

Phase 1

Completed

• Conditions: Tuberculosis
• Interventions: Drug: Isoniazida

• Registration Number: NCT02043314
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10
• Primary Completion: 2008-10
• Study Completion: 2009-03
• Status Verified: 2014-01
• Study First Submitted: 2014-01-17
• Study First Submitted QC: 2014-01-22
• Last Update Submitted: 2014-01-22
• Study First Posted: 2014-01-23
• Last Update Posted: 2014-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Isoniazida-LAQFA®	Isoniazida	3 coated tablet of 100mg
Isoniazida	Isoniazida	coated tablet of 300mg

Primary Outcome Measures

Name	Time	Method
Average bioequivalence based on the 90% CI	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.

Trial Locations

Locations (1)

Synchrophar - Ass. e Desenv. de Projetos Clínicos Ltda.; 🇧🇷 Campinas, São Paulo, Brazil