A clinical study to evaluate the safety and blood concentration of melatonin nasal suspension in healthy male research participants.
Phase 1
- Conditions
- Disturbances of onset and maintenance of sleep (insomnia).G47.0
- Registration Number
- RBR-3t7fcy
- Lead Sponsor
- Cosmed Indústria de Cosméticos e Medicamentos S.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- Male
- Target Recruitment
- Not specified
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 50 kg and BMI less than or equal to 30 kg / m2.
Exclusion Criteria
Research participants with complementary examinations outside normal values; history of excessive alcohol consumption; history of psychotropic drug use; be non-tolerant to the nasal spray test; history of upper or lower respiratory tract infection (1 month prior to study participation).
Study & Design
- Study Type
- Intervention
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method