Evidence map›Paper›PMID 35918587›Full record

Trial reportDrugs in R&D2022

Bioavailability of Oniria

Manuel Román Martinez, Eva García Aguilar, Samuel Martin Vílchez, Javier González García, Sergio Luquero-Bueno, Paola Camargo-Mamani, Gina Mejia-Abril, Laura García-Castro, Alejandro de Miguel-Cáceres, Paula Saz-Leal and 3 more

Open access · goldAbstract readClinical Trial, Phase IRandomized Controlled Trial
In one paragraph

Trial report in Drugs in R&D, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
2.3field-weighted citation impact, top 12% of its field
1 · What the graph read from it

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.

2 · The registry

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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 12 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Review
  4. Review
  5. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors at 3 institutions in 1 country.

Manuel Román MartinezClinical Pharmacology Department, Hospital Universitario de La Princesa Instituto de Investigación Sanitaria La Princesa (IP), Universidad Autónoma de Madrid (UAM), C/ Diego de León, 62, 28006, Madrid, Spain.
Eva García AguilarITF Research Pharma S.L.U, Madrid, Spain.
Samuel Martin VílchezClinical Pharmacology Department, Hospital Universitario de La Princesa Instituto de Investigación Sanitaria La Princesa (IP), Universidad Autónoma de Madrid (UAM), C/ Diego de León, 62, 28006, Madrid, Spain.
Javier González GarcíaITF Research Pharma S.L.U, Madrid, Spain.
Sergio Luquero-BuenoClinical Pharmacology Department, Hospital Universitario de La Princesa Instituto de Investigación Sanitaria La Princesa (IP), Universidad Autónoma de Madrid (UAM), C/ Diego de León, 62, 28006, Madrid, Spain.
Paola Camargo-MamaniClinical Pharmacology Department, Hospital Universitario de La Princesa Instituto de Investigación Sanitaria La Princesa (IP), Universidad Autónoma de Madrid (UAM), C/ Diego de León, 62, 28006, Madrid, Spain.
Gina Mejia-AbrilClinical Pharmacology Department, Hospital Universitario de La Princesa Instituto de Investigación Sanitaria La Princesa (IP), Universidad Autónoma de Madrid (UAM), C/ Diego de León, 62, 28006, Madrid, Spain.
Laura García-CastroClinical Pharmacology Department, Hospital Universitario de La Princesa Instituto de Investigación Sanitaria La Princesa (IP), Universidad Autónoma de Madrid (UAM), C/ Diego de León, 62, 28006, Madrid, Spain.
Alejandro de Miguel-CáceresClinical Pharmacology Department, Hospital Universitario de La Princesa Instituto de Investigación Sanitaria La Princesa (IP), Universidad Autónoma de Madrid (UAM), C/ Diego de León, 62, 28006, Madrid, Spain.
Paula Saz-LealITF Research Pharma S.L.U, Madrid, Spain.
Francisco Abad-SantosClinical Pharmacology Department, Hospital Universitario de La Princesa Instituto de Investigación Sanitaria La Princesa (IP), Universidad Autónoma de Madrid (UAM), C/ Diego de León, 62, 28006, Madrid, Spain.
Concepcion Nieto MagroITF Research Pharma S.L.U, Madrid, Spain.
Dolores Ochoa MazarroClinical Pharmacology Department, Hospital Universitario de La Princesa Instituto de Investigación Sanitaria La Princesa (IP), Universidad Autónoma de Madrid (UAM), C/ Diego de León, 62, 28006, Madrid, Spain. mdolores.ochoa@salud.madrid.org.ORCID http://orcid.org/0000-0002-1265-6600
Hospital Universitario de La Princesa · ESSpanish Clinical Research Network · ESInstituto de Salud Carlos III · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundMelatonin 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

objectivesThe main objective of the present study was to evaluate the relative oral bioavailability of Oniria

methodsWe 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

resultsTwo phases were clearly differentiated in the PK profile of Oniria

conclusionOniria

Indexed as

MelatoninBiological AvailabilityCross-Over StudiesDelayed-Action PreparationsHealthy VolunteersHumansTabletsDelayed-Action PreparationsMelatoninTablets

Identifiers

PMID35918587
PMCPMC9433621
OpenAlexW4289519029

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

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.