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

NCT04067791 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2020-06-09

No results posted yet for this study

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

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

Sponsors & Collaborators

  • KGK Science Inc.

    collaborator INDUSTRY

  • Pharmavite LLC

    lead INDUSTRY

Principal Investigators

  • David Crowley, MD · KGK Science Inc.

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-08-01
Primary Completion
2019-08-27
Completion
2019-08-27

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04067791 on ClinicalTrials.gov