RBR-8hc3zf
Not yet recruiting
Phase 1
A randomized, double-blind, monocentric, phase I clinical trial to assess the tolerability, safety, and pharmacokinetics of Melatonin Sublingual Suspension, after a single dose in healthy male participants
Instituto de Ciências Farmacêuticas0 sitesJuly 5, 2018
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Disturbances of onset and maintenance of sleep
- Sponsor
- Instituto de Ciências Farmacêuticas
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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.
Outcomes
Primary Outcomes
Not specified
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