Evidence map›Paper›PMID 24798274›Full record

ArticleAntimicrobial agents and chemotherapy2014

Posaconazole tablet pharmacokinetics: lack of effect of concomitant medications altering gastric pH and gastric motility in healthy subjects.

Walter K Kraft, Peter S Chang, Marlou L P S van Iersel, Hetty Waskin, Gopal Krishna, Wendy M Kersemaekers

Open access · bronzeAbstract read
In one paragraph

Article in Antimicrobial agents and chemotherapy, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 45 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
45citing papers in PubMed, 1 pooled it
8.8field-weighted citation impact, top 2% 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

45 citing papers in PubMed, 1 synthesis or guideline pooled it, 102 citations in OpenAlex.

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

6 authors at 3 institutions in 2 countries.

Walter K KraftDepartment of Pharmacology and Experimental Therapeutics, Thomas Jefferson University, Philadelphia, Pennsylvania, USA walter.kraft@jefferson.edu.
Peter S ChangDepartment of Pharmacology and Experimental Therapeutics, Thomas Jefferson University, Philadelphia, Pennsylvania, USA.
Marlou L P S van IerselMSD, Oss, Netherlands.
Hetty WaskinMerck & Co., Inc., Whitehouse Station, New Jersey, USA.
Gopal KrishnaMerck & Co., Inc., Whitehouse Station, New Jersey, USA.
Wendy M KersemaekersMSD, Oss, Netherlands.
Merck & Co., Inc., Rahway, NJ, USA (United States) · USMSD (Netherlands) · NLThomas Jefferson University · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Posaconazole oral suspension is an extended-spectrum triazole that should be taken with food to maximize absorption. A new posaconazole tablet formulation has demonstrated improved bioavailability over the oral suspension in healthy adults in a fasting state. This study evaluated the effects of concomitant medications altering gastric pH (antacid, ranitidine, and esomeprazole) and gastric motility (metoclopramide) on the pharmacokinetics of posaconazole tablets. This was a prospective open-label 5-way crossover study in 20 healthy volunteers. In each treatment period, a single 400-mg dose (4 100-mg tablets) of posaconazole was administered alone or with 20 ml antacid (2 g of aluminum hydroxide and 2 g of magnesium hydroxide), ranitidine (150 mg), esomeprazole (40 mg), or metoclopramide (15 mg). There was a ≥ 10-day washout between treatment periods. Posaconazole exposure, time to maximum concentration of drug in serum (Tmax), and apparent terminal half-life (t1/2) were similar when posaconazole was administered alone or with medications affecting gastric pH and gastric motility. Geometric mean ratios (90% confidence intervals [CIs]) of the area under the concentration-time curve from time zero to infinity (AUC0-inf) (posaconazole with medications affecting gastric pH and gastric motility versus posaconazole alone) were 1.03 (0.88-1.20) with antacid, 0.97 (0.84-1.12) with ranitidine, 1.01 (0.87-1.17) with esomeprazole, and 0.93 (0.79-1.09) with metoclopramide. Geometric mean ratios (90% CIs) of the maximum concentration of drug in serum (Cmax) were 1.06 (0.90-1.26) with antacid, 1.04 (0.88-1.23) with ranitidine, 1.05 (0.89-1.24) with esomeprazole, and 0.86 (0.73-1.02) with metoclopramide. In summary, in healthy volunteers, the pharmacokinetics of a single 400-mg dose of posaconazole tablets was not altered to a clinically meaningful extent when posaconazole was administered alone or with medications affecting gastric pH or gastric motility.

Indexed as

AdultAntacidsAntifungal AgentsArea Under CurveDrug InteractionsFemaleGastric AcidGastrointestinal MotilityHealthy VolunteersHistamine H1 AntagonistsHumansHydrogen-Ion ConcentrationMaleMiddle AgedProton Pump InhibitorsTabletsAntacidsAntifungal AgentsHistamine H1 AntagonistsposaconazoleProton Pump InhibitorsTabletsTriazoles

Identifiers

PMID24798274
PMCPMC4068532
OpenAlexW2152923337

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.