Pharmacological Action
Conditions
Brief summary
This project will develop and assess the feasibility and acceptability of a salive-based assay to monitor adherence to Mass Drug Administration (MDA) campaigns within Soil-transmitted helminthiasis (STH) control programs, evaluating the salive and serum pharmacokinetics of ALBENDAZOLE (ABZ) and its metabolites.The final goal is to obtain a field ready tool for the measurement of adherence to anthelmintic treatment at a community level that serves as a coverage/adherence indicator and a reference standard for other monitoring tools.
Interventions
DRUGAlbendazole
tablet administration after a meal contaning approximate 15 g of fat
Sponsors
Fundacion Mundo Sano
Universidad Nacional de Salta
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
Body Mass Index: 18 to 25. Physical exam without significant abnormal findings.
Exclusion criteria
Pregnancy Lactation Use of ABZ or other benzimidazole drugs in the previous 30 days History of intolerance to ABZ Malabsorption and/or other gastrointestinal conditions that might compromise ABZ absorption.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Salive albendazole levels | 72 hours | Albendazole and its metabolites will be measured in salive samples through high performance liquid chromatography (HPLC). |
Contacts
Primary ContactAlejandro J Krolewiecki, MD
Outcome results
None listed