NCT02845778

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started May 2016

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 24, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 27, 2016

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

July 27, 2016

Status Verified

July 1, 2016

Enrollment Period

3 months

First QC Date

July 24, 2016

Last Update Submit

July 24, 2016

Conditions

Pharmacokinetics of Melatonin

Keywords

melatoninpharmacokinetics

Outcome Measures

Primary Outcomes (1)

  • Concentration-time profile after 2.5, 5, and 10 mg Melatonin niosomes (MN) oral gel single dose administration

    Blood sampling

    0, 15, 30, 45, 60, 75, 90, 120, 180, 240, 300, 360 and 480 min after MN oral gel administration

Secondary Outcomes (1)

  • 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

Other Outcomes (1)

  • Adverse event after 2.5, 5, and 10 mg MN oral gel single dose administration

    0-24 h after MN oral gel administration

Study Arms (3)

melatonin niosomes oral gel 2.5 mg

EXPERIMENTAL

apply onto oral mucosa as single use

Drug: Melatonin

melatonin niosomes oral gel 5 mg

EXPERIMENTAL

apply onto oral mucosa as single use

Drug: Melatonin

melatonin niosomes oral gel 10 mg

EXPERIMENTAL

apply onto oral mucosa as single use

Drug: Melatonin

Interventions

MelatoninDRUG

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
melatonin niosomes oral gel 10 mgmelatonin niosomes oral gel 2.5 mgmelatonin niosomes oral gel 5 mg

Eligibility Criteria

Age18 Years - 30 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Academic Clinical Research Office

Amphur Muang, Changwat Khon Kaen, 40002, Thailand

RECRUITING

MeSH Terms

Interventions

Melatonin

Intervention Hierarchy (Ancestors)

TryptaminesIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Supawan Laohasiriwong, MD

    Department of Otorhinolaryngology, Faculty of Medicine, Khon Kaen University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Supawan Laohasiriwong, MD

CONTACT

+6643363565supawan125@gmail.com

Chatchanok Nukulkit, ฺBSc(Pharm)

CONTACT

+66850117408chatnuk@gmail.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department of Otorhinolaryngology, Faculty of Medicine

Study Record Dates

First Submitted

July 24, 2016

First Posted

July 27, 2016

Study Start

May 1, 2016

Primary Completion

August 1, 2016

Study Completion

March 1, 2017

Last Updated

July 27, 2016

Record last verified: 2016-07

Locations

TH(1)