Pharmacological ActionNCT05453045
Pharmacokinetics and Excretion of Albendazole and Its Metabolites in Saliva
A study testing Albendazole in people with Pharmacological Action, run by Universidad Nacional de Salta.
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… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Pharmacological Action
- What is being tested?
- Albendazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- 18 Jul 2022to 16 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body Mass Index: 18 to 25.
- Physical exam without significant abnormal findings.
Who cannot join
- 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 locations and contacts
No sites are listed yet.
About this study
Official title: Pharmacokinetics and Excretion of Albendazole and Its Metabolites in Saliva in Healthy Volunteers
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.
- Conditions
- Pharmacological Action
- Being tested
- Albendazole
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlbendazoleDrug
Also called Albendazole tablet, Albendazole 400mg po
tablet administration after a meal contaning approximate 15 g of fat
| Study group | Role | What they receive |
|---|---|---|
| Albendazole | Experimental | 400 mg po single dose Receives: Drug: Albendazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Salive albendazole levels
Albendazole and its metabolites will be measured in salive samples through high performance liquid chromatography (HPLC).
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2022
- Study start18 Jul 2022 (estimated)
- Primary completion30 Aug 2022 (estimated)
- Study completion16 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pharmacological ActionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Nacional de Salta
- Sponsor type
- University, hospital or other
- Collaborators
- Fundacion Mundo Sano
- Responsible party
- Principal investigator, Alejandro Krolewiecki, Universidad Nacional de Salta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05453045
- Sponsor's protocol ID
- ABZ0301
- Status last verified
- Jul 2022
- First submitted
- 6 Jul 2022
- Last updated
- 14 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics and Excretion of Albendazole and Its Metabolites in Saliva in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT05453045
- Acronym / sponsor ID
- ABZ0301
- Conditions
- Pharmacological Action
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Universidad Nacional de SaltaUniversity, hospital or other
- Collaborators
- Fundacion Mundo Sano
- Study start
- 18 Jul 2022 (estimated)
- Primary completion
- 30 Aug 2022 (estimated)
- Study completion
- 16 Dec 2022 (estimated)
- First posted
- 12 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Albendazole | Experimental | Drug: Albendazole400 mg po single dose |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Body Mass Index: 18 to 25.
- Physical exam without significant abnormal findings.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AlbendazoleAlso: Albendazole tablet, Albendazole 400mg potablet administration after a meal contaning approximate 15 g of fat | Drug | Albendazole |
Primary outcome
Salive albendazole levels
Time frame: 72 hours
Albendazole and its metabolites will be measured in salive samples through high performance liquid chromatography (HPLC).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Albendazole in people with Pharmacological Action, run by Universidad Nacional de Salta.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alejandro J Krolewiecki, MD (+5491131838673, alekrol@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Salive albendazole levels (time frame: 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2022.