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NCT05453045 Clinical Trial

Pharmacokinetics and Excretion of Albendazole and Its Metabolites in Saliva

Pharmacological Action Clinical Trial

Official title:
Pharmacokinetics and Excretion of Albendazole and Its Metabolites in Saliva in Healthy Volunteers

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05453045
Other study ID # ABZ0301
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date July 18, 2022
Est. completion date December 16, 2022

Study information
Verified date July 2022
Source Universidad Nacional de Salta
Contact Alejandro J Krolewiecki, MD
Phone +5491131838673
Email alekrol@hotmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 12
Est. completion date December 16, 2022
Est. primary completion date August 30, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 45 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Albendazole
tablet administration after a meal contaning approximate 15 g of fat

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Universidad Nacional de Salta Fundacion Mundo Sano

Outcome
Type Measure Description Time frame Safety issue
Primary Salive albendazole levels Albendazole and its metabolites will be measured in salive samples through high performance liquid chromatography (HPLC). 72 hours
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