Slaapstoornissen sleep onset Insomnia sleeping disorder
Conditions
Interventions
The intervention will consist of three intervention days with intervals of 6
days. During each intervention day the participant will administer one of the
formulations, respectively a 2,5mg melatoni
Sponsors
Universiteit Utrecht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: healthy volunteers (male) aged 18 to 35 years old without insomnia.
Exclusion criteria
Exclusion criteria: Exclusion criteria • Lactose intolerance. • Hepatic disease • Kidney disease • Auto-immune disease • Depression • Neurological disorders • Oromucosal diseases. Volunteers will not be enrolled if they are receiving medication during the study period, and within 4 weeks before the first intervention day, that are known inducers or inhibitors of melatonin metabolism or have farmacodynamic interactions with melatonin. ;Other exclusion criteria: • Use of stimulants, neuroleptics, benzodiazepines, antidepressants, hypnotics, beta-blokkers and clonidin within 4 weeks before the first intervention day and during the study. • Inhibitors of melatonin metabolism: o Fluvoxamin (CYP1A2, 2C19, 2C9 inhibitor), o 5- or 8 methoxypsoralen, o Cimetidin (CYP1A2 inhibitor), o Quinolones (1A2 inhibitor). • Inducers of melatonin metabolism: o Carbamazepin (substrate and inductor of CYP1A2) o Rifampicin (CYP2C9 inducer). o Omeprazol. • Oral anticoagulants
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The Tmax and relative bioavailability of oral and oromucasol melatonin derived from melatonin levels in salivary samples of healthy volunteers. | — |
Secondary
| Measure | Time frame |
|---|---|
| not applicable. | — |
Countries
Netherlands
Outcome results
None listed