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

NCT02043314 | Completed Phase 1 DMC

• 1 other identifier: 03.ISZ18-08BE.02
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Tuberculosis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Isoniazida-LAQFA®

ACTIVE COMPARATOR

3 coated tablet of 100mg

Drug: Isoniazida

Isoniazida

EXPERIMENTAL

coated tablet of 300mg

Drug: Isoniazida

Interventions

Isoniazida DRUG

Isoniazida; Isoniazida-LAQFA®

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

Sponsors & Collaborators

• Oswaldo Cruz Foundation: lead

Study Sites (1)

Synchrophar - Ass. e Desenv. de Projetos Clínicos Ltda.

Campinas, São Paulo, 13070-200, Brazil

Location

MeSH Terms

Conditions

Tuberculosis

Interventions

Isoniazid

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Hydrazines; Organic Chemicals; Isonicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Eduardo W Barroso, Dr

  Fundação Oswaldo Cruz

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2014
• First Posted: January 23, 2014
• Study Start: October 1, 2008
• Primary Completion: October 1, 2008
• Study Completion: March 1, 2009
• Last Updated: January 23, 2014

Record last verified: 2014-01

Locations

BR (1)