Clinical Trial

Melatonin

Study Description

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

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.

Location

Locations Selected Location

Methods

No pharmaceutical medication involved No pharmaceutical medication involved
Patients and healthy individuals accepted Patients and healthy individuals accepted

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

Additional Information

Official Study Title

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

Clinical Trial ID

NCT04067791

ParticipAid ID

bYEPnb