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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| spray before tablet | Experimental |
| |
| tablet before spray | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| a prolonged release tablet and a spray containing melatonin | Dietary Supplement | prolonged release tablet is dosed at 1.9mg and spray is dosed at 1mg for 2 oral sprays. |
|
| Measure | Description | Time Frame |
|---|---|---|
| evolution of the plasma melatonin concentration | the change in plasma melatonin concentration | over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray. |
| Measure | Description | Time Frame |
|---|---|---|
| evolution of the plasma concentration of 6-sulfatoxymelatonin | the change in plasma 6-sulfatoxymelatonin concentration | over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray. |
| evolution of the urinary concentration of 6-sulfatoxymelatonin |
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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,
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| Name | Affiliation | Role |
|---|---|---|
| Bruno Claustrat | PiLeJe | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CIC CEN EXPERIMENTAL / CEN Nutriment | Dijon | 21000 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37438493 | Derived | Ait Abdellah S, Raverot V, Gal C, Guinobert I, Bardot V, Blondeau C, Claustrat B. Bioavailability of Melatonin after Administration of an Oral Prolonged-Release Tablet and an Immediate-Release Sublingual Spray in Healthy Male Volunteers. Drugs R D. 2023 Sep;23(3):257-265. doi: 10.1007/s40268-023-00431-9. Epub 2023 Jul 12. |
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no sharing
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the change in urinary 6-sulfatoxymelatonin concentration |
| over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray. |
| evolution of the salivary concentration of melatonin | the change in salivary melatonin concentration | over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray. |
| adverse events | adverse events | during study participation, maximum 45 days |
| plasma melatonin AUC | Area Under the Curve of plasma melatonin | over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray. |
| plasma 6-sulfatoxymelatonin AUC | Area Under the Curve of plasma 6-sulfatoxymelatonin | over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray. |
| urinary 6-sulfatoxymelatonin AUC | Area Under the Curve of urinary 6-sulfatoxymelatonin | over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray. |
| salivary melatonin AUC | Area Under the Curve of salivary melatonin | over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray. |
| plasma melatonin Cmax | Peak concentration of plasma melatonin | over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray. |
| plasma 6-sulfatoxymelatonin Cmax | Peak concentration of plasma 6-sulfatoxymelatonin | over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray. |
| urinary 6-sulfatoxymelatonin Cmax | Peak concentration of urinary 6-sulfatoxymelatonin | over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray. |
| salivary melatonin Cmax | Peak concentration of salivary melatonin | over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray. |
| plasma melatonin Tmax | Time take to reach Cmax of plasma melatonin | over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray. |
| plasma 6-sulfatoxymelatonin Tmax | Time take to reach Cmax of plasma 6-sulfatoxymelatonin | over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray. |
| urinary 6-sulfatoxymelatonin Tmax | Time take to reach Cmax of urinary 6-sulfatoxymelatonin | over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray. |
| salivary melatonin Tmax | Time take to reach Cmax of salivary melatonin | over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray. |
| plasma melatonin half life | time required for the concentration of plasma melatonin to decrease to half of its starting dose | over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray. |
| plasma 6-sulfatoxymelatonin half life | time required for the concentration of plasma 6-sulfatoxymelatonin to decrease to half of its starting dose | over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray. |
| urinary 6-sulfatoxymelatonin half life | time required for the concentration of urinary 6-sulfatoxymelatonin to decrease to half of its starting dose | over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray. |
| salivary melatonin half life | time required for the concentration of salivary melatonin to decrease to half of its starting dose | over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray. |