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
Sponsor study identifier
interventional
18
1 country
1
Study Start
August 1, 2019
Actual (reported)Primary Completion
August 27, 2019
Actual (reported)Study Completion
August 27, 2019
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 27, 2019
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 1, 2019
Actual (reported)August 19, 2019
Actual (reported)August 26, 2019
Actual (reported)August 27, 2019
Actual (reported)August 27, 2019
Actual (reported)Comparison of the pharmacokinetics of prolonged-release melatonin and immediate-release melatonin by evaluating the area under the curve (AUC 0-10h)
7 days
Comparison of the pharmacokinetics of prolonged-release melatonin and immediate-release melatonin by evaluating the time to peak concentration (tmax)
7 days
Comparison of the pharmacokinetics of prolonged-release melatonin and immediate-release melatonin by evaluating the peak concentration (Cmax)
7 days
Comparison of the pharmacokinetics of prolonged-release melatonin and immediate-release melatonin by evaluating the absorption rate constant
7 days
Change in blood pressure after an acute administration of either prolonged-release melatonin or immediate-release melatonin
7 days
Change in heart rate after an acute administration of either prolonged-release melatonin or immediate-release melatonin
7 days
Change in weight after an acute administration of either prolonged-release melatonin or immediate-release melatonin
7 days
4.47 mg melatonin in a bi-layer prolonged-release capsule
4.47 mg melatonin in a standard release bi-layer capsule
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Formulated product
Prolonged-Release Melatonin
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
View registry recordFormulated product
Immediate-Release Melatonin
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
View registry recordKGK Science Inc.
London, Ontario, N6A 5R8, Canada
Mun JG, Wang D, Doerflein Fulk DL, Fakhary M, Gualco SJ, Grant RW, Mitmesser SH. A Randomized, Double-Blind, Crossover Study to Investigate the Pharmacokinetics of Extended-Release Melatonin Compared to Immediate-Release Melatonin in Healthy Adults. J Diet Suppl. 2024;21(2):182-194. doi: 10.1080/19390211.2023.2206475. Epub 2023 May 7.
David Crowley, MD
KGK Science Inc.
18 participants (actual enrollment reported by the registry).
First Submitted
August 19, 2019
First Posted
August 26, 2019
Study Start
August 1, 2019
Actual (reported)Comparison of the pharmacokinetics of prolonged-release melatonin and immediate-release melatonin by evaluating the elimination rate constant
7 days
Comparison of the pharmacokinetics of prolonged-release melatonin and immediate-release melatonin by evaluating the absorption half-life
7 days
Comparison of the pharmacokinetics of prolonged-release melatonin and immediate-release melatonin by evaluating the elimination half-life
7 days
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
August 27, 2019
Actual (reported)Study Completion
August 27, 2019
Actual (reported)Last Updated
June 9, 2020
Record last verified: 2020-06
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Source: ClinicalTrials.gov.
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