Clinical trial NCT02845778: Pharmacokinetics of Melatonin Niosomes Oral Gel in Healthy Volunteers
Official title: Pharmacokinetics of Melatonin Niosomes Oral Gel in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Pharmacokinetics of Melatonin
Keywords: melatonin
pharmacokinetics
Lead sponsor: Khon Kaen University
Sponsor class: OTHER
First posted: 2016-07-27
Enrollment: 15
Sex: MALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Concentration-time profile after 2.5, 5, and 10 mg Melatonin niosomes (MN) oral gel single dose administration
timeFrame: 0, 15, 30, 45, 60, 75, 90, 120, 180, 240, 300, 360 and 480 min after MN oral gel administration
Secondary outcomes:
measure: 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
timeFrame: 0-480 min after MN oral gel administration
Other outcomes:
measure: Adverse event after 2.5, 5, and 10 mg MN oral gel single dose administration
timeFrame: 0-24 h after MN oral gel administration
Locations:
city: Amphur Muang
country: Thailand
facility: Academic Clinical Research Office
state: Khon Kaen
Study officials:
affiliation: Department of Otorhinolaryngology, Faculty of Medicine, Khon Kaen University
name: Supawan Laohasiriwong, MD
role: PRINCIPAL_INVESTIGATOR
References: