Pharmacokinetics of Melatonin
Conditions
Keywords
melatonin, pharmacokinetics
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.
Interventions
DRUGMelatonin
Each sachet contains 0.5 g
Sponsors
Khon Kaen University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to 30 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Adverse event after 2.5, 5, and 10 mg MN oral gel single dose administration | 0-24 h after MN oral gel administration | nausea, vomiting, headache, irritability and others |
Countries
Thailand
Contacts
Primary ContactSupawan Laohasiriwong, MD
Backup ContactChatchanok Nukulkit, ฺBSc(Pharm)
Outcome results
None listed