Pharmacokinetics of Melatonin Niosomes Oral Gel in Healthy Volunteers

Pharmacokinetics of Melatonin Clinical Trial

Official title:

Pharmacokinetics of Melatonin Niosomes Oral Gel in Healthy Volunteers

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02845778
• Other study ID #: IN58358
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: July 24, 2016
• Last updated: July 24, 2016
• Start date: May 2016
• Est. completion date: March 2017

Study information

• Verified date: July 2016
• Source: Khon Kaen University
• Contact: Supawan Laohasiriwong, MD
• Phone: +6643363565
• Email: supawan125[@]gmail.com
• Is FDA regulated: No
• Health authority: Thailand: Khon Kaen University Ethics Committee for Human Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: March 2017
• Est. primary completion date: August 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 30 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Pharmacokinetics of Melatonin

Intervention

Drug:
• Melatonin
Each sachet contains 0.5 g

Locations

Country	Name	City	State
Thailand	Academic Clinical Research Office	Amphur Muang	Khon Kaen

Sponsors (1)

Lead Sponsor	Collaborator
Khon Kaen University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse event after 2.5, 5, and 10 mg MN oral gel single dose administration	nausea, vomiting, headache, irritability and others	0-24 h after MN oral gel administration	Yes
Primary	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	Yes
Secondary	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).	0-480 min after MN oral gel administration	Yes