Trial reportDrugs in R&D2024
Melatonin Bioavailability After Oral Administration of a New Delayed-Release Form in Healthy Male Volunteers.
Trial report in Drugs in R&D, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05419466 (Kinetic of Plasmatic Compounds and Metabolites of a Melatonin-based Formulation in Healthy Subjects), which is not on this map. Cited by 1 paper.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Kinetic of Plasmatic Compounds and Metabolites of a Melatonin-based Formulation in Healthy Subjects
Who cites it
1 citing paper in PubMed.
- Melatonin in Integrative Oncology: Biological Mechanisms, Therapeutic Evidence and Implementation Strategies.Oncology research · 2026Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundTwo main types of galenic formulation, immediate release and prolonged release, have been developed to optimize melatonin bioavailability. We recently described the kinetic profile of a prolonged-release form generating a peak of plasma melatonin 1 h (T
objectiveThe objective is to investigate melatonin bioavailability after administration of this new delayed-release form (DR form).
methodsIn this single-centre open-label study, 12 healthy male volunteers received one tablet of the DR form containing 1.9 mg melatonin, 10 mg zinc and 200 mg lemon balm extract (Melissa officinalis L aerial parts). Blood samples were collected for 12 h, beginning at 8:00 am. Plasma concentrations of melatonin and 6-sulfatoxymelatonin (6-SMT), the main hepatic melatonin metabolite, were determined by radioimmunoassay.
resultsA progressive increase in plasma melatonin concentrations was observed from 20 min and a peak about 3 h after intake (C
conclusionsThe melatonin release profile was consistent with what was anticipated for the DR form. The DR form generated a 2 h delayed T TRIAL REGISTRY: Registration number: NCT05419466.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.