At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-blind, Comparator-controlled, Cross-over Study to Investigate the Pharmacokinetics of Prolonged-release Melatonin Compared to Standard, Immediate-release Melatonin in Healthy Adults
In Brief
A Phase 1 clinical trial evaluating Prolonged-Release Melatonin and Immediate-Release Melatonin for Healthy. Completed, enrolled 18 participants across 1 site.
Detailed Summary
A study comparing the pharmacokinetics of prolonged-release melatonin versus standard, immediate-release melatonin. Multiple blood draws over a 10-hour period will be analysed to determine the area under the curve, time to peak concentration, peak concentration, absorption rate constant, elimination rate constant, absorption half-life, and elimination half-life. Vital signs, hematology parameters, clinical chemistry parameters, and incidence of adverse events are also analysed.
Study Details
Timeline
Interventions
4.47 mg melatonin in a bi-layer prolonged-release capsule
4.47 mg melatonin in a standard release bi-layer capsule