Metabolism and safety of different melatonin doses for healthy children and adolescents

Phase 1

• Conditions: Healthy children and adolescents; MedDRA version: 22.0Level: SOCClassification code 10022891Term: InvestigationsSystem Organ Class: 10022891 - Investigations; Therapeutic area: Not possible to specify

• Registration Number: EUCTR2020-002187-31-DK
• Lead Sponsor: Department of Paediatrics, Herlev Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-09-29
• Last Update Posted: 12 March 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

1. Healthy subjects aged 3-17 years of age (both inclusive) who are able to swallow tablets of 9.5 mm
2. Signed informed consent form
Are the trial subjects under 18? yes
Number of subjects for this age range: 36
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Diagnosis of a neurodevelopmental disorder
2.Participation in other studies that may interfere with results
3.If the investigator finds that the child is not eligible due to other diseases, cannot co-operate etc.
4.Hereditary fructose intolerance
5.Intake of medications that may interfere with the results i.e.
Fluvoxamine, psoralenes, cimetidine, estrogens, quinolones, rifampicin, carbamezapine.
6.Unable to avoid caffeine, alcohol or nicotine 24 hours prior to study
7.Pregnancy (Pregnancy tests will be performed in girls from 12 years of age with menarche)
8.BMI for age outside the limits of ± 2SD (15)
9. Dental work in the last 24 hours

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified