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Serum Pharmacokinetic Disposition and Urinary Excretion of Albendazole

NCT03192449 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2017-06-22

No results posted yet for this study

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.

Conditions

  • Soil Transmitted Helminthiasis
  • Neglected Tropical Diseases

Interventions

DRUG

Albendazole.

Single dose 400mg orally

Sponsors & Collaborators

  • CIVETAN CONICET, Facultad de Ciencias Veterinarias, UNCPBA. Tandil

    collaborator UNKNOWN

  • Universidad Nacional de Salta

    lead OTHER

Principal Investigators

  • Alejandro J Krolewiecki, MD/PhD · Universidad Nacional de Salta

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-11-21
Primary Completion
2016-12-15
Completion
2017-01-20

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03192449 on ClinicalTrials.gov