Serum Pharmacokinetic Disposition and Urinary Excretion of Albendazole

• Status: Completed
• Trial end date: 2017-01-20
• Target enrollment: 0
• Participant gender: All

Summary

Mass drug administration (MDA) of albendazole (ABZ) to school-age and pre-school-age children is the currently recommended strategy for controlling soil-transmitted helminthiasis (STH) in endemic areas. Recent mathematical modelling suggests that community-wide MDA will be required in order to interrupt transmission of STH. DEWORM3 aims to determine the feasibility of eliminating STH through expanded and intensified MDA strategies. In order to ensure rigorous trial results, it is crucial that the definition of such MDA coverage is informed by unbiased, empirical data. The Centro de Investigación Veterinaria de Tandil (CIVETAN) and Instituto de Investigaciones en Enfermedades Tropicales Universidad Nacional de Salta collaborate on scientific research related to pharmacokinetic studies of ABZ.

This proposal describes the request for funding from DEWORM3 to conduct a study of the serum pharmacokinetic characteristics and urinary excretion of ABZ and its metabolites in non-infected human volunteers to better understand the use of urinary analysis of ABZ as a measure of MDA adherence in the context of DEWORM3.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Universidad Nacional de Salta
• Collaborator: CIVETAN CONICET, Facultad de Ciencias Veterinarias, UNCPBA. Tandil
• Treatments: Albendazole

Criteria

Inclusion Criteria:

1. Weight between 45 and 75 Kg.

2. Physical exam without significant abnormal findings.

Exclusion Criteria:

1. Intake of ABZ or other benzimidazole drugs within the last 30 days.

2. Malabsorption or other GI syndromes that could compromise the tolerability or absorption of ABZ.

3. History of hypersensitivity or intolerance to ABZ or its inactive ingredients.

4. Acute clinical conditions.

5. Pregnancy or breast feeding.