NCT02845778 is a Phase 1/Phase 2 clinical trial of Melatonin in Pharmacokinetics of Melatonin, sponsored by Khon Kaen University.

Who is sponsoring NCT02845778?

NCT02845778 is sponsored by Khon Kaen University.

What drugs are being tested in NCT02845778?

Interventions in NCT02845778: Melatonin.

What condition does NCT02845778 study?

NCT02845778 studies Pharmacokinetics of Melatonin.

Is NCT02845778 still recruiting?

NCT02845778 is currently status unknown. Last updated 24 July 2016.

Last reviewed 2016-07-24 · How we verify

NCT02845778

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Pharmacokinetics of Melatonin Niosomes Oral Gel in Healthy Volunteers

Status unknown Phase 1/Phase 2 Last updated 24 July 2016

What this trial tests

Phase 1/Phase 2 trial testing Melatonin in Pharmacokinetics of Melatonin in 15 participants. Status unknown.

Timeline

1 May 2016

Primary endpoint
1 August 2016

1 March 2017

Quick facts

Lead sponsor	Khon Kaen University
Phase	Phase 1/Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	triple
Enrollment	15
Start date	1 May 2016
Primary completion	1 August 2016
Estimated completion	1 March 2017
Sites	1 location across Thailand

Drugs / interventions tested

Melatonin (MELATONIN) — full drug profile →

Conditions studied

Pharmacokinetics of Melatonin — all drugs for Pharmacokinetics of Melatonin →

Sponsor

Khon Kaen University

Who can join

Adults 18 to 30, male only, with Pharmacokinetics of Melatonin. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Concentration-time profile after 2.5, 5, and 10 mg Melatonin niosomes (MN) oral gel single dose administration
Time frame: 0, 15, 30, 45, 60, 75, 90, 120, 180, 240, 300, 360 and 480 min after MN oral gel administration
Blood sampling

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Niosomes as Vesicular Carriers: From Formulation Strategies to Stimuli-Responsive Innovative Modulations for Targeted Drug Delivery.
Ababei-Bobu A, Profire BȘ, Iacob AT, Chirliu OM, et al · · 2025 · cited 3× · PMID 41304810 · DOI 10.3390/pharmaceutics17111473

Verify or expand the search:

Other trials of Melatonin

Trials testing the same drug.

NCT07221968 — Melatonin for the Treatment of DEE-SWAS · Phase 2 · not yet recruiting
NCT07503600 — The Effect of Adjunctive Melatonin With Colistin in Patients With Multidrug-Resistant Gram-Negative Bacterial Infections · Phase 3 · not yet recruiting
NCT07375342 — Melatonin for Post Tonsillectomy Emergence Agitation in Pediatric · NA · enrolling by invitation
NCT07305350 — EFFICACY OF MELATONIN IN MANAGEMENT OF HYPOXIC ISCHEMIC ENCEPHALOPATHY (HIE) IN NEONATES · Phase 2 · active not recruiting
NCT07096635 — Oral Melatonin With Intra Articular Analgesia on Pain After Arthroscopic Anterior Cruciate Ligament Reconstruction · NA · not yet recruiting

Other Khon Kaen University trials

Trials by the same sponsor.

NCT07494396 — An AI-Based Erythema Measurement System for Psoriasis Lesions · not yet recruiting
NCT07054775 — Comparison of Pruritus Incidence After Intrathecal Morphine 0.1 vs 0.2 mg in Cesarean Section · Phase 4 · recruiting
NCT06994520 — Efficacy of Topical Cannabidiol for Eczema · Phase 2 · active not recruiting
NCT06958029 — Postoperative Atrial Fibrillation in Cardiac Surgery · recruiting
NCT06289257 — Analysis of Vitamin D and VDR Expression in Endometriosis: A Case-Control Study · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02845778 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Khon Kaen University
Last refreshed: 24 July 2016

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02845778.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing