Clinical study to evaluate the effect of sublingual gel melatonin in healthy research participants
Not Applicable
- Conditions
- Disorders of onset and maintenance of sleep (insomnia).G47.0
- Registration Number
- RBR-2vfqnz
- Lead Sponsor
- Instituto de Ciências Farmacêuticas
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- Not specified
- Target Recruitment
- Not specified
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
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.
Study & Design
- Study Type
- Intervention
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method