Evidence map›Paper›PMID 34181478›Full record

Trial reportAntimicrobial agents and chemotherapy2021

Pharmacokinetics and Bioequivalence of Isavuconazole Administered as Isavuconazonium Sulfate Intravenous Solution via Nasogastric Tube or Orally in Healthy Subjects.

Amit Desai, Melanie Helmick, Nakyo Heo, Selina Moy, Stephen Stanhope, Ronald Goldwater, Nancy Martin

Open access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Antimicrobial agents and chemotherapy, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 1 pooled it
0.6field-weighted citation impact, top 30% 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

6 citing papers in PubMed, 1 synthesis or guideline pooled it, 11 citations in OpenAlex.

  1. Guideline
  2. Article
  3. Article
  4. Article
  5. Isavuconazole use and TDM in real-world pediatric practice.Antimicrobial agents and chemotherapy · 2023
    Article
  6. 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

7 authors at 2 institutions in 1 country.

Amit DesaiAstellas Pharma Global Development, Northbrook, Illinois, USA.
Melanie HelmickAstellas Pharma Global Development, Northbrook, Illinois, USA.
Nakyo HeoAstellas Pharma Global Development, Northbrook, Illinois, USA.
Selina MoyAstellas Pharma Global Development, Northbrook, Illinois, USA.
Stephen StanhopeAstellas Pharma Global Development, Northbrook, Illinois, USA.
Ronald GoldwaterParexel International Corporation, Baltimore, Maryland, USA.
Nancy MartinAstellas Pharma Global Development, Northbrook, Illinois, USA.
Astellas Pharma (United States) · USPAREXEL International (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

For critically ill patients with invasive fungal infections, a nasogastric (NG) tube can be an alternative route for administration of isavuconazonium sulfate (ISAVUSULF). This was a randomized, open-label, 2-period, 2-sequence single-dose crossover study comparing single doses of 372 mg ISAVUSULF intravenous (i.v.) solution via NG tube (test formulation) to 372-mg ISAVUSULF capsules for oral administration (reference formulation) in healthy male and female subjects. A single dose of ISAVUSULF was administered under fasting conditions on day 1 of each period, with a washout of 30 days between periods. Pharmacokinetic (PK) samples were collected predose through day 21. Standard safety and tolerability assessments were conducted in each period. The analysis of variance estimate of the study population demonstrates that the isavuconazole i.v. NG tube administration geometric least-squares (LS) mean values of the observed maximum concentration (

Indexed as

Therapeutic EquivalencyArea Under CurveCross-Over StudiesFemaleHealthy VolunteersHumansMaleNitrilesPyridinesTabletsTriazolesisavuconazoleNitrilesPyridinesTabletsTriazolesbioequivalenceisavuconazolenasogastric tube

Identifiers

PMID34181478
PMCPMC8370193
OpenAlexW3176778672

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.