The Relative Bio-availability of Oral and Oromucosal Melatonin in Different Formulations in Healthy Human Volunteers.
Launched by UTRECHT UNIVERSITY · Apr 3, 2014
Trial Information
Current as of May 17, 2025
Completed
Keywords
ClinConnect Summary
The circadian rhythm, the sleep-wake cycle, is mainly regulated by melatonin. The synthesis of melatonin is stimulated by the absence of light, leading to peak serum levels before bedtime. In humans, this endogenous "signaling" neurohormone induces sleep.
Exogenous melatonin can be beneficial in different sleep disturbances including delayed sleep phase insomnia (Dahlitz et al. 1991, Regestein et al. 1995), melatonin- deficiency-related insomnia (especially in elderly) (Garfinkel 1995, Etzioni et al. 1995) and shift work sleep disorder (Folkard et al. 1993, Skene et al. 1996).
A randomize...
Gender
MALE
Eligibility criteria
- Inclusion Criteria:
- • Volunteers (male) aged from 18 to 35 years old without insomnia.
- Exclusion Criteria:
- • Lactose intolerance.
- • Hepatic disease
- • Kidney disease
- • Auto-immune disease
- • Depression
- • Neurological disorders
- • Oromucosal diseases.
About Utrecht University
Utrecht University, a leading research institution in the Netherlands, is committed to advancing scientific knowledge and improving healthcare through innovative clinical trials. With a strong emphasis on interdisciplinary collaboration, the university brings together experts from various fields to conduct rigorous research that addresses pressing health challenges. Utrecht University is dedicated to ethical research practices and prioritizes patient safety and well-being, ensuring that all trials contribute to meaningful advancements in medical science. Through its state-of-the-art facilities and a robust network of healthcare partners, the university aims to translate research findings into practical solutions that enhance patient outcomes and inform public health policy.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Utrecht, , Netherlands
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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