NCT04067791

A Study to Investigate the Pharmacokinetics of Prolonged-release Melatonin Compared to Standard, Immediate-release Melatonin in Healthy Adults

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Pharmavite LLC · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Prolonged-Release Melatonin	4.47 mg melatonin in a bi-layer prolonged-release capsule
DIETARY_SUPPLEMENT	Immediate-Release Melatonin	4.47 mg melatonin in a standard release bi-layer capsule

Timeline

• Start date: 2019-08-01
• Primary completion: 2019-08-27
• Completion: 2019-08-27
• First posted: 2019-08-26
• Last updated: 2020-06-09

Locations

1 site across 1 country: Canada