Pharmacokinetics of Melatonin Niosomes Oral Gel in Healthy Volunteers

Phase 1

• Conditions: Pharmacokinetics of Melatonin
• Interventions: Drug: Melatonin

• Registration Number: NCT02845778
• Lead Sponsor: Khon Kaen University

Brief Summary

Melatonin is an endogenous hormone. It is able to promote nighttime sleeping and could induce sleep at daytime in adult and children with the nonpainful diagnostic procedure. However, previous formulation had problems of unstability of product and low oral bioavailability. Melatonin niosomes oral gels are formulated in order to overcome the problem of drug absorption and stability. This study is a randomized, double-blind, three phase crossover design in 15 male volunteers. Melatonin niosomes oral gel will be applied at doses 2.5, 5, and 10 mg with 7 days washout for each period. The pharmacokinetics data, sleep induction effect, and adverse event will be determined.

Detailed Description

This study will determine the pharmacokinetics, sleep induction effect, and adverse event after apply melatonin niosomes (MN) oral gel 2.5, 5, and 10 mg per dose in 15 male healthy volunteers. The pharmacokinetic parameters include maximum plasma concentration (Cmax), area under the curve (AUC), time to peak concentration (Tmax), elimination half-life (t1/2). Sleep induction will be determined as sleep onset and duration after use MN oral gels using actigraph and behavior observation. A polysomnography using electrode placement derive from multiple sleep latency test (MSLT) protocol will be used in some subjects. Adverse event will be evaluated by investigator.

Study Timeline

• Study Start: 2016-05
• Status Verified: 2016-07
• Study First Submitted: 2016-07-24
• Study First Submitted QC: 2016-07-24
• Last Update Submitted: 2016-07-24
• Study First Posted: 2016-07-27
• Last Update Posted: 2016-07-27
• Primary Completion: 2016-08
• Study Completion: 2017-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 15

Inclusion Criteria

• male
• age 18-30 years
• body mass index 18.5-25 kg/m2
• general good health and no underlying disease by physical examination and laboratory testing (blood urea nitrogen, creatinine, bilirubin, aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase, complete blood count)
• provide signed informed consent for study participation

Exclusion Criteria

• history of allergies to melatonin products
• use of any drugs, vitamins, or supplements within 30 days before participation
• smoke or alcohol consumption within 1 week before participation
• blood or plasma donation within 30 days before participation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
melatonin niosomes oral gel 2.5 mg	Melatonin	apply onto oral mucosa as single use
melatonin niosomes oral gel 10 mg	Melatonin	apply onto oral mucosa as single use
melatonin niosomes oral gel 5 mg	Melatonin	apply onto oral mucosa as single use

Primary Outcome Measures

Name	Time	Method
Concentration-time profile after 2.5, 5, and 10 mg Melatonin niosomes (MN) oral gel single dose administration	0, 15, 30, 45, 60, 75, 90, 120, 180, 240, 300, 360 and 480 min after MN oral gel administration	Blood sampling

Secondary Outcome Measures

Name	Time	Method
Sleep induction effect (sleep onset latency, total sleep time, and wake after sleep onset) after 2.5, 5, and 10 mg MN oral gel single dose administration	0-480 min after MN oral gel administration	Sleep induction effect will be measured by using actigraph, behavior observation (all subjects), and Multiple sleep latency test (5 from 15 subjects).

Trial Locations

Locations (1)

Academic Clinical Research Office; 🇹🇭 Amphur Muang, Khon Kaen, Thailand