Evidence map›Paper›PMID 19075045›Full record

Trial reportAntimicrobial agents and chemotherapy2009

Pharmacokinetics and absorption of posaconazole oral suspension under various gastric conditions in healthy volunteers.

Gopal Krishna, Allen Moton, Lei Ma, Matthew M Medlock, James McLeod

Abstract readClinical Trial, Phase IRandomized Controlled Trial
In one paragraph

Trial report in Antimicrobial agents and chemotherapy, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 133 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
133citing papers in PubMed, 3 pooled it
–field-weighted citation impact
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

133 citing papers in PubMed, 3 syntheses or guidelines pooled it.

  1. Pooled it
  2. Updated antimicrobial dosing recommendations for obese patients.Antimicrobial agents and chemotherapy · 2024
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  10. Pharmacokinetics of posaconazole prophylaxis of patients with acute myeloid leukemia.Journal of infection and chemotherapy : official journal of the Japan Society of Chemotherapy · 2015
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73 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

5 authors.

Gopal KrishnaEarly Clinical Research and Experimental Medicine, Schering-Plough Research Institute, Kenilworth, New Jersey 07033, USA. gopal.krishna@spcorp.com
Allen Moton
Lei Ma
Matthew M Medlock
James McLeod

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

A four-part, randomized, crossover study with healthy subjects evaluated the effects of gastric pH, the dosing frequency and prandial state, food consumption timing, and gastric motility on the absorption of posaconazole. In part 1, a single dose (SD) of posaconazole (400 mg) was administered alone or with an acidic beverage or a proton pump inhibitor (PPI), or both. In part 2, posaconazole (400 mg twice daily and 200 mg four times daily) was administered for 7 days with and without a nutritional supplement (Boost). In part 3, an SD of posaconazole (400 mg) was administered while the subjects were fasting and before, during, and after a high-fat meal. In part 4, an SD of posaconazole (400 mg) and the nutritional supplement were administered alone, with metoclopramide, and with loperamide. Compared to the results obtained with posaconazole alone, administration with an acidic beverage increased the posaconazole maximum concentration in plasma (C(max)) and the area under the concentration-time curve (AUC) by 92% and 70%, respectively, whereas a higher gastric pH decreased the posaconazole C(max) and AUC by 46% and 32%, respectively. Compared to the results obtained with posaconazole alone, posaconazole at 400 mg or at 200 mg plus the nutritional supplement increased the posaconazole C(max) and AUC by 65% and 66%, respectively, and by up to 137% and 161%, respectively. Administration before a high-fat meal increased the C(max) and the AUC by 96% and 111%, respectively, while administration during and after the meal increased the C(max) and the AUC by up to 339% and 387%, respectively. Increased gastric motility decreased the C(max) and the AUC by 21% and 19%, respectively. Strategies to maximize posaconazole exposure in patients with absorption difficulties include administration with or after a high-fat meal, with any meal or nutritional supplement, with an acidic beverage, or in divided doses and the avoidance of proton pump inhibitors.

Indexed as

Carbonated BeveragesFood-Drug InteractionsAdministration, OralAdultAntifungal AgentsAnti-Ulcer AgentsArea Under CurveBlack or African AmericanCross-Over StudiesDose-Response Relationship, DrugDrug Administration ScheduleEatingFastingFemaleGastric MucosaHumansAntifungal AgentsAnti-Ulcer AgentsOmeprazoleposaconazoleSuspensionsTriazoles

Identifiers

PMID19075045
PMCPMC2650585

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.