Pharmacokinetics of Melatonin Niosomes Oral Gel in Healthy Volunteers
Status:
Unknown status
Trial end date:
2017-03-01
Target enrollment:
Participant gender:
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.