Bioavailability of Oniria
Drugs in R&D
September 1, 2022
Manuel Román Martinez et al. (13 authors)
Clinical Trial, Phase IJournal ArticleRandomized Controlled TrialHuman StudyClinical
Extracted Claims (6)
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
melatonin | decrease | sleep induction | - | - | plays a key role in | #1 |
melatonin | decrease | sleep onset latency | - | - | reducing | #2 |
Oniria | increase | absorption rate | healthy volunteers | - | showed a faster absorption rate | #3 |
Oniria | increase | maximum concentration | healthy volunteers | - | showed a higher maximum concentration | #4 |
Oniria | decrease | time to reach maximum concentration | healthy volunteers | - | showed a shorter time to reach maximum concentration | #5 |
Oniria | increase | relative oral bioavailability | healthy volunteers | - | showed a higher relative oral bioavailability | #6 |
Abstract
BACKGROUND: Melatonin is an endogenous substance which plays a key role in sleep induction by reducing sleep onset latency; it has been approved by the European Food Safety Authority as a food supplement for exogenous administration. Oniria OBJECTIVES: The main objective of the present study was to evaluate the relative oral bioavailability of Oniria METHODS: We performed an open-label, cross-over, randomized, phase I clinical study with two sequences and three periods involving 14 healthy volunteers. We characterized the endogenous melatonin circadian profile (period 1) and pharmacokinetics (PK) of both Oniria RESULTS: Two phases were clearly differentiated in the PK profile of Oniria CONCLUSION: Oniria
Medical Subject Headings (MeSH)
Biological AvailabilityCross-Over StudiesDelayed-Action PreparationsHealthy VolunteersHumansMelatoninTablets
Study Links
PubMed ID35918587
Citation Metrics
Total Citations4
Citations/Year1.3
Relative Citation Ratio0.87
NIH Percentile45.1%
Research Impact Scores
APT Score0.50
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