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Pharmacokinetics and Excretion of Albendazole and Its Metabolites in Saliva

Sponsor
Universidad Nacional de Salta (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05453045
Collaborator
Fundacion Mundo Sano (Other)
12
Enrollment
1
Arm
5
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
12 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Pharmacokinetics and Excretion of Albendazole and Its Metabolites in Saliva in Healthy Volunteers
Anticipated Study Start Date :
Jul 18, 2022
Anticipated Primary Completion Date :
Aug 30, 2022
Anticipated Study Completion Date :
Dec 16, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Albendazole

400 mg po single dose

Drug: Albendazole
tablet administration after a meal contaning approximate 15 g of fat
Other Names:
  • Albendazole tablet, Albendazole 400mg po

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Salive albendazole levels [72 hours]

      Albendazole and its metabolites will be measured in salive samples through high performance liquid chromatography (HPLC).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 45 Years
    Sexes Eligible for Study:
    All
    Accepts 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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Universidad Nacional de Salta
    • Fundacion Mundo Sano

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Alejandro Krolewiecki, Researcher, Universidad Nacional de Salta
    ClinicalTrials.gov Identifier:
    NCT05453045
    Other Study ID Numbers:
    • ABZ0301
    First Posted:
    Jul 12, 2022
    Last Update Posted:
    Jul 14, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:
    Albendazole

    Study Results

    No Results Posted as of Jul 14, 2022