Disorders of onset and maintenance of sleep (insomnia).
Conditions
Interventions
Twenty-four (24) research participants, twelve (12) male and twelve (12) female, will receive sublingual gel with the active melatonin in 04 periods of the study.
First period: Research participants
Fourth period: Research participants will receive two (2) actuations of the 100µL 10mg / g sublingual melatonin gel valve.
The interval between each period will be at least fourteen (14) days.
Drug
F51.0
Sponsors
Instituto de Ciências Farmacêuticas
Instituto de Ciências Farmacêuticas
Cosmed Indústria de Cosméticos e Medicamentos S.A.
Eligibility
Age
55 Years to No maximum
Inclusion criteria
Inclusion criteria: Participant of both sexes, aged 55 or over. Survey participant with laboratory results, type 1 urine examination, clinical evaluation, vital signs, and ECG within normal range and / or any deviation from normality classified as not clinically significant.
Exclusion criteria
Exclusion criteria: Complementary test results are 3 times higher than normal values unless clinically irrelevant. Women who are breastfeeding. Participant with a history of hypersensitivity to the study drug or chemically related compounds.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ECG 12 variations. It will be calculated using the logistic model considering dose as covariable. The results of each test will be classified into 3 categories: Normal, Not Clinically Significant (NCS) or Clinically Significant (CS). Volunteers with Normal or NCS results will continue for the next period. . For volunteers with CS results, the principal investigator will decide which ones can continue for the next period.;Laboratory tests. Will be calculated using the logistic model considering dose as covariable. The results of each test will be classified into 3 categories: Normal, Not Clinically Significant (NCS) or Clinically Significant (CS). Volunteers with Normal or NCS results will proceed to the next period. For volunteers with CS results, the principal investigator will decide which ones can proceed to the next period.;Clinical evaluation. It will be calculated using the logistic model considering dose as covariable. The results of each test will be classified into 3 categories: Normal, Not Clinically Significant (NCS) or Clinically Significant (CS). Volunteers with Normal or NCS results will continue for the next period. . For volunteers with CS results, the principal investigator will decide which ones can continue for the next period. | — |
Secondary
| Measure | Time frame |
|---|---|
| Maximum concentration. Individual and mean graphs of plasma concentration vs. time, in original scale, for each dose will be presented. Tables of plasma concentrations and pharmacokinetic parameters will be presented.;Area under the curve. Area under the blood concentration curve versus time measured from time 0 to time t, where t is the time relative to the last experimentally determined concentration, is calculated by the trapezoid method. | — |
Countries
Brazil
Contacts
Public ContactKarini Bellorio
Instituto de Ciências Farmacêuticas
Outcome results
None listed