Evidence map›Paper›PMID 25824210›Full record

Trial reportAntimicrobial agents and chemotherapy2015

Effect of a high-fat meal on the pharmacokinetics of 300-milligram posaconazole in a solid oral tablet formulation.

Wendy M Kersemaekers, Peter Dogterom, Jialin Xu, Eugene E Marcantonio, Rik de Greef, Hetty Waskin, Marlou L P S van Iersel

Open access · bronzeAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Antimicrobial agents and chemotherapy, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 32 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
32citing papers in PubMed, 1 pooled it
3.7field-weighted citation impact, top 7% 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

32 citing papers in PubMed, 1 synthesis or guideline pooled it, 61 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Trial
  5. Article
  6. Article
  7. Article
  8. Article
  9. Article
  10. Article
  11. Review
  12. Systemic Antifungal Therapy for Invasive Pulmonary Infections.Journal of fungi (Basel, Switzerland) · 2023
    Review
  13. Article
  14. A Review of Population Pharmacokinetic Models of Posaconazole.Drug design, development and therapy · 2022
    Review
  15. Review
  16. Review
  17. Review
  18. Supratherapeutic Posaconazole Concentration in a Pediatric Transplant Patient With ConfirmedThe journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG · 2021
    Article
  19. Review
  20. 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 1 institution in 1 country.

Wendy M KersemaekersMerck Sharp & Dohme Corp., Kenilworth, New Jersey, USA.
Peter DogteromMerck Sharp & Dohme Corp., Kenilworth, New Jersey, USA.
Jialin XuMerck Sharp & Dohme Corp., Kenilworth, New Jersey, USA.
Eugene E MarcantonioMerck Sharp & Dohme Corp., Kenilworth, New Jersey, USA Eugene.marcantonio@merck.com.
Rik de GreefMerck Sharp & Dohme Corp., Kenilworth, New Jersey, USA.
Hetty WaskinMerck Sharp & Dohme Corp., Kenilworth, New Jersey, USA.
Marlou L P S van IerselMerck Sharp & Dohme Corp., Kenilworth, New Jersey, USA.
Merck & Co., Inc., Rahway, NJ, USA (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Posaconazole in oral suspension must be taken multiple times a day with food (preferably a high-fat meal) to ensure adequate exposure among patients. We evaluated the effect of food on the bioavailability of a new delayed-release tablet formulation of posaconazole at the proposed clinical dose of 300 mg once daily in a randomized, open-label, single-dose, two-period crossover study with 18 healthy volunteers. When a single 300-mg dose of posaconazole in tablet form (3 tablets × 100 mg) was administered with a high-fat meal, the posaconazole area under the concentration-time curve from 0 to 72 h (AUC0-72) and maximum concentration in plasma (Cmax) increased 51% and 16%, respectively, compared to those after administration in the fasted state. The median time to Cmax (Tmax) shifted from 5 h in the fasted state to 6 h under fed conditions. No serious adverse events were reported, and no subject discontinued the study due to an adverse event. Six of the 18 subjects reported at least one clinical adverse event; all of these events were mild and short lasting. The results of this study demonstrate that a high-fat meal only modestly increases the mean posaconazole exposure (AUC), ∼1.5-fold, after administration of posaconazole tablets, in contrast to the 4-fold increase in AUC observed previously for a posaconazole oral suspension given with a high-fat meal.

Indexed as

Administration, OralAdolescentAdultAgedAntifungal AgentsCross-Over StudiesFemaleHumansMaleMiddle AgedTabletsTriazolesYoung AdultAntifungal AgentsposaconazoleTabletsTriazoles

Identifiers

PMID25824210
PMCPMC4432131
OpenAlexW1883163115

What OpenQuestion holds

Textmetadata
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.