A Phase 1/2 interventional study of Melatonin in Pharmacokinetics of Melatonin, sponsored by Khon Kaen University. Status unknown at 1 site in Thailand. Open to male participants aged 18 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-07-27.
Sponsored by Khon Kaen University · Phase 1/2 and Interventional
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.
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.
Khon Kaen University is the lead sponsor of 160 studies on the registry; 24 are open to participants now.
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Exclusion Criteria:
apply onto oral mucosa as single use
Drug: Melatonin
apply onto oral mucosa as single use
Drug: Melatonin
apply onto oral mucosa as single use
Drug: Melatonin
Each sachet contains 0.5 g
Also known as: Melatonin niosomes oral gel 5 mg/g, Melatonin niosomes oral gel 10 mg/g, Melatonin niosomes oral gel 20 mg/g
Concentration-time profile after 2.5, 5, and 10 mg Melatonin niosomes (MN) oral gel single dose administration
Blood sampling
Time frame: 0, 15, 30, 45, 60, 75, 90, 120, 180, 240, 300, 360 and 480 min after MN oral gel administration
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).
Time frame: 0-480 min after MN oral gel administration
Adverse event after 2.5, 5, and 10 mg MN oral gel single dose administration
nausea, vomiting, headache, irritability and others
Time frame: 0-24 h after MN oral gel administration
Plan to share: Undecided
No publications or documents are linked to this record.
This study is status unknown, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.
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Khon Kaen University