Trial reportDrugs in R&D2023
Bioavailability of Melatonin after Administration of an Oral Prolonged-Release Tablet and an Immediate-Release Sublingual Spray in Healthy Male Volunteers.
Trial report in Drugs in R&D, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04574141 (Randomized, Open-label Bioavailability Study of the Kinetics of Plasma, Urinary and Salivary Concentrations of Melatonin and 6-sulfatoxymelatonin Subsequent to the Consumption of Melatonin-rich Food Supplements With Different Galenic Forms), which is not on this map. Cited by 13 papers.
What it found
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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.
Randomized, Open-label Bioavailability Study of the Kinetics of Plasma, Urinary and Salivary Concentrations of Melatonin and 6-sulfatoxymelatonin Subsequent to the Consumption of Melatonin-rich Food Supplements With Different Galenic Forms
Who cites it
13 citing papers in PubMed, 16 citations in OpenAlex.
- Melatonin Bioavailability After Oral Administration of a New Delayed-Release Form in Healthy Male Volunteers.Drugs in R&D · 2024Trial
- Melatonin beyond chronobiology: integrating pharmacokinetics, dose-exposure forecasting, and clinical evidence.Molecular biology reports · 2026Review
- BMAL1 Dysregulation as a Contributing Mechanism Linking Obesity to Oocyte and Endometrial Dysfunction in IVF.International journal of molecular sciences · 2026Review
- Harnessing spatiotemporal melatonin delivery from engineered platforms for targeted microenvironment remodeling in peripheral neuropathy.Materials today. Bio · 2026Review
- Ion-Triggered In Situ Gel Combined with Melatonin Liposomes: Breaking Through the Dual Barriers of Nasal and Brain Delivery to Treat Insomnia.Pharmaceutics · 2026Article
- Melatonin Targets Mitochondrial Redox Homeostasis: Optimizing the Intracellular Microenvironment.International journal of molecular sciences · 2026Review
- Melatonin in Integrative Oncology: Biological Mechanisms, Therapeutic Evidence and Implementation Strategies.Oncology research · 2026Review
- Beyond Sleeping Disorders, the Role of Melatonin in Skin Diseases and Emerging Applications in Dermatology and Topical Therapy.Gels (Basel, Switzerland) · 2025Review
- Melatonin Interplay in Physiology and Disease-The Fountain of Eternal Youth Revisited.Biomolecules · 2025Review
- Melatonin: a natural guardian in cancer treatment.Frontiers in pharmacology · 2025Review
- Melatonin's Impact on Wound Healing.Antioxidants (Basel, Switzerland) · 2024Review
- Safety, pharmacokinetics, and food-effect of pivmecillinam after single- and multiple-dose in healthy Chinese subjects: a phase I study.Naunyn-Schmiedeberg's archives of pharmacology · 2024Article
- The Vital Role of Melatonin and Its Metabolites in the Neuroprotection and Retardation of Brain Aging.International journal of molecular sciences · 2024Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors at 4 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe benefit of exogenous melatonin is based on its bioavailability, which depends on the galenic form, the route of administration, the dosage, and the individual absorption and rate of hepatic metabolism.
objectiveThe objective of this study is to investigate the bioavailability of melatonin after administration of an oral prolonged-release tablet (PR form) and an immediate-release sublingual spray (IR form). The main metabolite of melatonin, 6-sulfatoxymelatonin (6-SMT), was also measured, which has not been done in previous studies. Its determination is important as an index of the hepatic transformation of melatonin.
methodsIn this single-center, open-label, randomized, crossover study, 14 healthy male volunteers received one tablet of the PR form (1.9 mg melatonin) or two sprays of the IR form (1 mg melatonin) during two visits separated by a washout period. Blood samples were collected over 7 and 9 h for the IR and PR form, respectively, to determine the main pharmacokinetic parameters.
resultsThe observed kinetics were consistent with those expected for immediate and prolonged-release forms. Pulverization of the spray resulted in an early, high plasma melatonin peak (C
conclusionsThe results suggest that the galenic forms containing melatonin assessed in this study are suitable for the treatment of certain sleep disorders such as sleep onset delay and transient nocturnal awakenings for the IR form and insomnia for the PR form. TRIAL REGISTRY: Registration number: NCT04574141.
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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.