A clinical study to evaluate the safety and blood concentration of Melatonin sublingual in healthy male research participants

Phase 1

• Conditions: Disturbances of onset and maintenance of sleep; Healthy volunteers; C10.886.425.800.800; M01.774.500

• Registration Number: RBR-8hc3zf
• Lead Sponsor: Instituto de Ciências Farmacêuticas

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-07-05
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Not specified
• 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 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.

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Adverse Event Reports (EAs) obtained by general questions or declared spontaneously, classified according to WHO-UMC system (The WHO Uppsala Monitoring Center)

Secondary Outcome Measures

Name	Time	Method
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