Evidence map›Paper›PMID 34652564›Full record

Trial reportEuropean journal of drug metabolism and pharmacokinetics2022

Impact of a High-Fat Meal and Sprinkled Administration on the Bioavailability and Pharmacokinetics of Viloxazine Extended-Release Capsules (Qelbree

Zhao Wang, Alisa R Kosheleff, Lilian W Adeojo, Oyinkansola Odebo, Tesfaye Liranso, Stefan Schwabe, Azmi Nasser

Open access · hybridAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in European journal of drug metabolism and pharmacokinetics, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.9field-weighted citation impact, top 27% 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

1 citing paper in PubMed, 7 citations in OpenAlex.

  1. Review
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

7 authors at 1 institution in 1 country.

Zhao WangSupernus Pharmaceuticals, Inc., 9715 Key West Avenue, Rockville, MD, USA.
Alisa R KosheleffSupernus Pharmaceuticals, Inc., 9715 Key West Avenue, Rockville, MD, USA.
Lilian W AdeojoSupernus Pharmaceuticals, Inc., 9715 Key West Avenue, Rockville, MD, USA.
Oyinkansola OdeboSupernus Pharmaceuticals, Inc., 9715 Key West Avenue, Rockville, MD, USA.
Tesfaye LiransoSupernus Pharmaceuticals, Inc., 9715 Key West Avenue, Rockville, MD, USA.
Stefan SchwabeSupernus Pharmaceuticals, Inc., 9715 Key West Avenue, Rockville, MD, USA.
Azmi NasserSupernus Pharmaceuticals, Inc., 9715 Key West Avenue, Rockville, MD, USA. anasser@supernus.com.
Supernus Pharmaceuticals (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

objectivesViloxazine extended-release (viloxazine ER) capsules (Qelbree

methodsThis was a randomized, open-label, crossover, three-treatment, three-period study in healthy adults using orally administered single-dose viloxazine ER 200 mg capsules. Subjects consumed: (1) an intact capsule after a 10-h fast (control condition); (2) the capsule contents sprinkled on one tablespoon of applesauce; and (3) an intact capsule with a standard high-fat meal. Blood samples were collected for 48 h post-dosing. Relative bioavailability analyses were performed to assess the impact of each test condition against the control condition (intact capsule, fasting). The absence of an impact was indicated if the 90% confidence interval (CI) for the least-squares geometric mean ratio (LSGMR) of maximal concentration (C

resultsOut of 27 enrolled subjects, 25 were included in the pharmacokinetic analysis. The LSGMR (90% CI) for viloxazine ER sprinkled vs. intact were 90.10% (83.35-97.40) for C

conclusionsThese data suggest that viloxazine ER can be consumed sprinkled on applesauce or as intact capsules with or without meals without significantly changing its pharmacokinetics.

Indexed as

Diet, High-FatFood-Drug InteractionsAdministration, OralAdolescentAdultAntidepressive Agents, Second-GenerationArea Under CurveAttention Deficit Disorder with HyperactivityBiological AvailabilityCapsulesCross-Over StudiesDelayed-Action PreparationsFemaleHealthy VolunteersHumansMaleAntidepressive Agents, Second-GenerationCapsulesDelayed-Action PreparationsViloxazine

Identifiers

PMID34652564
PMCPMC8752548
OpenAlexW3207564110

What OpenQuestion holds

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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.