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Study identifier: NCT06801379 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

A Novel Inhaled Formulation of Melatonin to Treat Adults With Insomnia: Pharmacokinetic Study

Condition: Insomnia  ·  Sponsor: Woolcock Institute of Medical Research

PhaseEARLY_Phase 1
Planned participants5
Who can joinAll sexes, 55 Years to no upper limit
Healthy volunteersNo

About this study

The goal of this clinical trial is to explore the potential benefits of an inhaled version of melatonin compared to oral melatonin tablets on adults with insomnia. The main question the trial aims to answer: is the time required for inhaled melatonin to reach peak concentration in the blood and then be eliminated from body different to that of oral melatonin tablets, in adults with insomnia? 5 participants will: * Visit the research institute for a screening visit and for a daytime visit to take a melatonin treatment then provide blood samples over the course of 8 hours for each study drug treatment (3 visits in total) * Take 100 μg of inhaled melatonin (2 inhaler puffs) once * Take a 4 mg of oral melatonin (2 tablets) once

This description comes directly from the study's public registry record.

Talk to the study team

Hui Xin Ong, PhD  ·  0298053094  ·  huixin.ong@mq.edu.au

Darren Zhao, PhD  ·  0298053094  ·  mat.leslie@woolcock.org.au

Always discuss trial participation with your own doctor first.

Locations (1)

Woolcock Institute of Medical ResearchMacquarie Park, New South Wales, AustraliaRecruiting

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Source record: clinicaltrials.gov/study/NCT06801379