Disturbances of onset and maintenance of sleep
Conditions
Interventions
Experimental group: 56 healthy men who will receive single dose of melatonin sublingual suspension 5mg/mL and 10mg/mL at doses of 0,25
1 e 2mg and fasted state.
Control group: 8 healthy men receiving a single dose of sublingual suspension with placebo and fasted state.
Drug
Sponsors
Instituto de Ciências Farmacêuticas
Instituto de Ciências Farmacêuticas
Cosmed Indústria de Cosméticos e Medicamentos S.A.
Eligibility
Age
18 Years to 35 Years
Inclusion criteria
Inclusion criteria: Healthy research participants; male gender; age equal to 18 and less than or equal to 35 years; body weight greater than or equal to 50Kg and BMI less than or equal to 30Kg/m2.
Exclusion criteria
Exclusion criteria: Research participants with complementary examinations outside normal values; history of excessive alcohol consumption; history of psychotropic drug use; have participated in any experimental drug study within 1 year before starting the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse Event Reports (EAs) obtained by general questions or declared spontaneously, classified according to WHO-UMC system (The WHO Uppsala Monitoring Center) | — |
Secondary
| Measure | Time frame |
|---|---|
| Determination of the pharmacokinetic parameter% ASCExtrap - Percent of ASC0-inf that is due to the extrapolation from the last to the infinity, using Phoenix WinNonlin software, version 6.4 or higher, after quantification of plasma concentrations by liquid chromatography | — |
Countries
Brazil
Contacts
Public ContactKarini Bellorio
Instituto de Ciências Farmacêuticas
Outcome results
None listed