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HEALTH Trial - Healthy Adult Evaluation of Ivermectin Bioequivalence: Infant Versus Standard Formulation

NCT06918665 · Status: SUSPENDED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2026-03-20

No results posted yet for this study

Summary

This is a clinical trial to compare two formulations of the drug ivermectin: the standard 3mg tablet formulation versus a newly developed infant formula preparation. The goal of the trial is to determine if the new formulation functions in the same way, tastes the same and causes no new side effects. The trial will involve 52 participants who will be healthy adult volunteers. The participants will receive both formulations - the order they receive each formulation will be assigned randomly (similar to the toss of a coin).

Conditions

  • Scabies

Interventions

DRUG

ivermectin infant formula preparation

The ivermectin infant formula preparation is produced by micronizing the standard 3mg ivermectin tablet and then blending it with Stage 1 infant formula (Blackmores brand) to produce a homogenous powder. This powder blend of ivermectin and infant formula is then filled into food grade clear capsules.

DRUG

Standard ivermectin 3mg tablet

standard 3mg ivermectin tablet

Sponsors & Collaborators

  • Monash University

    collaborator OTHER

  • Murdoch Childrens Research Institute

    lead OTHER

Principal Investigators

  • Amanda Gwee · Murdoch Childrens Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-07-31
Primary Completion
2027-07-01
Completion
2027-08-01

Countries

  • Australia

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06918665 on ClinicalTrials.gov