CIC CEN EXPERIMENTAL / CEN Nutriment
Dijon, 21000, France
NCT Number: NCT04574141
This study is conducted to clinically document the melatonin bioavailability of two dietary supplements containing melatonin : one prolonged release tablet dosed at 1.9mg and one spray dosed at 1mg for 2 oral sprays.
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Notify Me18 year–45 year
Male
Interventional
Not applicable
Dijon, 21000, France
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Drug intake: Fluvoxamine, 5- or 8-methoxypsoralen, cimetidine, carbamazepine and rifampicin, analgesics, Liver abnormality known or detected at the screening visit and judged to be clinically significant by the investigator, Known autoimmune disease,
prolonged release tablet is dosed at 1.9mg and spray is dosed at 1mg for 2 oral sprays.
Time frame: over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray.
the change in plasma melatonin concentration
Time frame: over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray.
the change in plasma 6-sulfatoxymelatonin concentration
Time frame: over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray.
the change in urinary 6-sulfatoxymelatonin concentration
Time frame: over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray.
the change in salivary melatonin concentration
Time frame: during study participation, maximum 45 days
adverse events
Time frame: over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray.
Area Under the Curve of plasma melatonin
Time frame: over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray.
Area Under the Curve of plasma 6-sulfatoxymelatonin
Time frame: over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray.
Area Under the Curve of urinary 6-sulfatoxymelatonin
Time frame: over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray.
Area Under the Curve of salivary melatonin
Time frame: over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray.
Peak concentration of plasma melatonin
Time frame: over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray.
Peak concentration of plasma 6-sulfatoxymelatonin
Time frame: over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray.
Peak concentration of urinary 6-sulfatoxymelatonin
Time frame: over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray.
Peak concentration of salivary melatonin
Time frame: over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray.
Time take to reach Cmax of plasma melatonin
Time frame: over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray.
Time take to reach Cmax of plasma 6-sulfatoxymelatonin
Time frame: over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray.
Time take to reach Cmax of urinary 6-sulfatoxymelatonin
Time frame: over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray.
Time take to reach Cmax of salivary melatonin
Time frame: over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray.
time required for the concentration of plasma melatonin to decrease to half of its starting dose
Time frame: over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray.
time required for the concentration of plasma 6-sulfatoxymelatonin to decrease to half of its starting dose
Time frame: over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray.
time required for the concentration of urinary 6-sulfatoxymelatonin to decrease to half of its starting dose
Time frame: over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray.
time required for the concentration of salivary melatonin to decrease to half of its starting dose
PiLeJe
Industry
Randomized, Open-label Bioavailability Study of the Kinetics of Plasma, Urinary and Salivary Concentrations of Melatonin and 6-sulfatoxymelatonin Subsequent to the Consumption of Melatonin-rich Food Supplements With Different Galenic Forms
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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