Pharmacokinetics of Melatonin Niosomes Oral Gel in Healthy Volunteers

Study Overview
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Brief Summary
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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
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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.

Official Title
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Pharmacokinetics of Melatonin Niosomes Oral Gel in Healthy Volunteers

Conditions
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Pharmacokinetics of Melatonin

Intervention / Treatment
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* Drug: Melatonin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: melatonin niosomes oral gel 2.5 mg<br>apply onto oral mucosa as single use | Drug: Melatonin<br>* Each sachet contains 0.5 g<br>* Other names: Melatonin niosomes oral gel 20 mg/g;|
| Experimental: melatonin niosomes oral gel 5 mg<br>apply onto oral mucosa as single use | Drug: Melatonin<br>* Each sachet contains 0.5 g<br>* Other names: Melatonin niosomes oral gel 20 mg/g;|
| Experimental: melatonin niosomes oral gel 10 mg<br>apply onto oral mucosa as single use | Drug: Melatonin<br>* Each sachet contains 0.5 g<br>* Other names: Melatonin niosomes oral gel 20 mg/g;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Sleep induction effect will be measured by using actigraph, behavior observation (all subjects), and Multiple sleep latency test (5 from 15 subjects). | 0-480 min after MN oral gel administration | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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melatonin, pharmacokinetics