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Pharmacokinetics and Excretion of Albendazole and Its Metabolites in Saliva

N

National University of Salta

Status

Not yet enrolling

Conditions

Pharmacological Action

Treatments

Drug: Albendazole

Study type

Interventional

Funder types

Other

Identifiers

NCT05453045
ABZ0301

Details and patient eligibility

About

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.

Enrollment

12 estimated patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Supportive Care

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

12 participants in 1 patient group

Albendazole
Experimental group
Description:
400 mg po single dose
Treatment:
Drug: Albendazole

Trial contacts and locations

0

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Central trial contact

Alejandro J Krolewiecki, MD

Data sourced from clinicaltrials.gov

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