Back to resultsA Bioequivalence Study of Two Different Dosages of Isoniazid Tablet Formulations in Human Healthy Volunteers
Primary Purpose
Tuberculosis
Status
Completed
Phase
Phase 1
Locations
Brazil
Study Type
Interventional
Intervention
Isoniazida
Sponsored by
About this trial
This is an interventional treatment trial for Tuberculosis
Eligibility Criteria
Inclusion Criteria:
- healthy men and women
- aged between 18 and 50 years
- BMI between 18.5 and 29.9 kg/m²
Sites / Locations
- Synchrophar - Ass. e Desenv. de Projetos Clínicos Ltda.
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Isoniazida-LAQFA®
Isoniazida
Arm Description
3 coated tablet of 100mg
coated tablet of 300mg
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02043314
First Posted
January 17, 2014
Last Updated
January 22, 2014
Sponsor
Oswaldo Cruz Foundation
1. Study Identification
Unique Protocol Identification Number
NCT02043314
Brief Title
A Bioequivalence Study of Two Different Dosages of Isoniazid Tablet Formulations in Human Healthy Volunteers
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
March 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Oswaldo Cruz Foundation
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tuberculosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Isoniazida-LAQFA®
Arm Type
Active Comparator
Arm Description
3 coated tablet of 100mg
Arm Title
Isoniazida
Arm Type
Experimental
Arm Description
coated tablet of 300mg
Intervention Type
Drug
Intervention Name(s)
Isoniazida
Primary Outcome Measure Information:
Title
Average bioequivalence based on the 90% CI
Description
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.
Time Frame
up to 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
healthy men and women
aged between 18 and 50 years
BMI between 18.5 and 29.9 kg/m²
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eduardo W Barroso, Dr
Organizational Affiliation
Fundação Oswaldo Cruz
Official's Role
Principal Investigator
Facility Information:
Facility Name
Synchrophar - Ass. e Desenv. de Projetos Clínicos Ltda.
City
Campinas
State/Province
São Paulo
ZIP/Postal Code
13070-200
Country
Brazil
12. IPD Sharing Statement
Learn more about this trial
A Bioequivalence Study of Two Different Dosages of Isoniazid Tablet Formulations in Human Healthy Volunteers
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