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Pharmacokinetics of Melatonin Niosomes Oral Gel in Healthy Volunteers

NCT02845778 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2016-07-27

No results posted yet for this study

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.

Conditions

  • Pharmacokinetics of Melatonin

Interventions

DRUG

Melatonin

Each sachet contains 0.5 g

Sponsors & Collaborators

  • Khon Kaen University

    lead OTHER

Principal Investigators

  • Supawan Laohasiriwong, MD · Department of Otorhinolaryngology, Faculty of Medicine, Khon Kaen University

Study Design

Allocation
RANDOMIZED
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
30 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-05-31
Primary Completion
2016-08-31
Completion
2017-03-31

Countries

  • Thailand

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02845778 on ClinicalTrials.gov