Pharmacokinetics and Excretion of Albendazole and Its Metabolites in Saliva

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-18

Study Completion Date

2022-12-16

Brief Summary

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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.

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Detailed Description

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Conditions

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Pharmacological Action

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Albendazole

400 mg po single dose

Group Type EXPERIMENTAL

Albendazole

Intervention Type DRUG

tablet administration after a meal contaning approximate 15 g of fat

Interventions

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Albendazole

tablet administration after a meal contaning approximate 15 g of fat

Intervention Type DRUG

Other Intervention Names

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Albendazole tablet, Albendazole 400mg po

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes