Trial reportBritish journal of clinical pharmacology2004
Effect of food on the relative bioavailability of two oral formulations of posaconazole in healthy adults.
Trial report in British journal of clinical pharmacology, 2004. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 105 papers, 2 of them syntheses that pooled it.
What it found
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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.
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.
Who cites it
105 citing papers in PubMed, 2 syntheses or guidelines pooled it, 324 citations in OpenAlex.
- Guideline
- Clinical Practice Guideline for the Management of Candidiasis: 2016 Update by the Infectious Diseases Society of America.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2016Guideline
- Pharmacokinetics and Safety of Posaconazole Administered by Intravenous Solution and Oral Tablet in Healthy Chinese Subjects and Effect of Food on Tablet Bioavailability.Clinical drug investigation · 2019Trial
- Effect of food on the pharmacokinetics of YH4808, a potassium-competitive acid blocker, after single- and multiple-oral dosing in healthy subjects.European journal of clinical pharmacology · 2018Trial
- Population pharmacokinetic modeling of itraconazole and hydroxyitraconazole for oral SUBA-itraconazole and sporanox capsule formulations in healthy subjects in fed and fasted states.Antimicrobial agents and chemotherapy · 2015Trial
- Pharmacokinetics of posaconazole prophylaxis of patients with acute myeloid leukemia.Journal of infection and chemotherapy : official journal of the Japan Society of Chemotherapy · 2015Trial
- Pharmacokinetics and safety study of posaconazole intravenous solution administered peripherally to healthy subjects.Antimicrobial agents and chemotherapy · 2015Trial
- Effect of a high-fat meal on the pharmacokinetics of 300-milligram posaconazole in a solid oral tablet formulation.Antimicrobial agents and chemotherapy · 2015Trial
- Therapeutic drug monitoring of posaconazole in patients with acute myeloid leukemia or myelodysplastic syndrome.Antimicrobial agents and chemotherapy · 2012Trial
- A new solid oral tablet formulation of posaconazole: a randomized clinical trial to investigate rising single- and multiple-dose pharmacokinetics and safety in healthy volunteers.The Journal of antimicrobial chemotherapy · 2012Trial
- Single-dose phase I study to evaluate the pharmacokinetics of posaconazole in new tablet and capsule formulations relative to oral suspension.Antimicrobial agents and chemotherapy · 2012Trial
- Pharmacokinetics of different dosing strategies of oral posaconazole in patients with compromised gastrointestinal function and who are at high risk for invasive fungal infection.Antimicrobial agents and chemotherapy · 2012Trial
- Effect of pH and comedication on gastrointestinal absorption of posaconazole: monitoring of intraluminal and plasma drug concentrations.Clinical pharmacokinetics · 2011Trial
- Efficacy and safety of intravenous voriconazole and intravenous itraconazole for antifungal prophylaxis in patients with acute myelogenous leukemia or high-risk myelodysplastic syndrome.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2011Trial
- Effect of varying amounts of a liquid nutritional supplement on the pharmacokinetics of posaconazole in healthy volunteers.Antimicrobial agents and chemotherapy · 2009Trial
- Pharmacokinetics of posaconazole administered orally or by nasogastric tube in healthy volunteers.Antimicrobial agents and chemotherapy · 2009Trial
- Pharmacokinetics and absorption of posaconazole oral suspension under various gastric conditions in healthy volunteers.Antimicrobial agents and chemotherapy · 2009Trial
- Intrapulmonary pharmacokinetics and pharmacodynamics of posaconazole at steady state in healthy subjects.Antimicrobial agents and chemotherapy · 2009Trial
- Posaconazole plasma concentrations in juvenile patients with invasive fungal infection.Antimicrobial agents and chemotherapy · 2007Trial
- Effect of a nutritional supplement on posaconazole pharmacokinetics following oral administration to healthy volunteers.Antimicrobial agents and chemotherapy · 2006Trial
45 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
aimsThis randomized, crossover, single-dose study evaluated the relative oral bioavailability of posaconazole suspension and coprecipitate tablet formulations. Additionally, the study determined whether systemic exposure to posaconazole was affected by prandial status or by the fat content of a meal.
methodsThis was a randomized, open-label, four-way crossover, single-dose study in 20 healthy men. Posaconazole pharmacokinetics were evaluated over 72 h following a single oral dose of posaconazole suspension (200 mg/5 ml) administered with a high-fat meal, a nonfat breakfast, or after a 10 h fast, or posaconazole tablets (2 x 100 mg) administered with a high-fat meal.
resultsThe posaconazole suspension showed a significant increase in bioavailability compared with the tablet (increase in AUC(0,72 h) = 137% (90% confidence interval (CI) 119%, 156% and Cmax = 123% (90% CI 104%, 146%). The mean increases in AUC(0,72 h) and Cmax values were about 400% when administered with a high-fat meal compared with administration of the suspension in the fasting state (AUC(0,72 h) 90% CI 343%, 448%; Cmax 90% CI 352%, 493%). Administration of the suspension with a nonfat meal enhanced exposure, resulting in an increase in AUC(0,72 h) of 264% (90% CI 231%, 302%) and in Cmax of 296% (90% CI 250%, 350%) relative to the fasted state.
conclusionsThe suspension formulation of posaconazole was associated with enhanced systemic exposure and increased relative bioavailability compared with the tablet. Food substantially enhanced the rate and extent of posaconazole absorption in healthy subjects.
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Registered trials
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.