Clinical Trial

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

Study acronym: Mela-Nia
Unknown Early Phase 1
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Record status
This record was last updated July 18, 2025 (before its estimated December 31, 2025 completion). Its status may not reflect the trial's current state.
Summary
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
Protocol Amendment History 1 change
critical Trial status changed: Recruiting → Unknown 2026-08-02
Trial Details
NCT Number NCT06801379
Lead Sponsor Woolcock Institute of Medical Research
Conditions Insomnia
Enrollment 5 participants
Start Date 2025-07-01
Primary Completion 2025-12-31 (estimated)
Study Completion 2026-05-01 (estimated)
Updated on ClinicalTrials.gov 2025-07-18