Trial reportAntimicrobial agents and chemotherapy2003
Pharmacokinetics, safety, and tolerability of oral posaconazole administered in single and multiple doses in healthy adults.
Trial report in Antimicrobial agents and chemotherapy, 2003. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 103 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.
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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
103 citing papers in PubMed, 2 syntheses or guidelines pooled it, 299 citations in OpenAlex.
- Clinical practice guidelines for the management of candidiasis: 2009 update by the Infectious Diseases Society of America.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2009Guideline
- Antifungal pharmacodynamics: Latin America's perspective.The Brazilian journal of infectious diseases : an official publication of the Brazilian Society of Infectious DiseasesPooled it
- 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
- Efficacy, safety and feasibility of antifungal prophylaxis with posaconazole tablet in paediatric patients after haematopoietic stem cell transplantation.Journal of cancer research and clinical oncology · 2017Trial
- Posaconazole Pharmacokinetics in Healthy Cats after Oral and Intravenous Administration.Journal of veterinary internal medicine · 2016Trial
- Pharmacokinetics of posaconazole prophylaxis of patients with acute myeloid leukemia.Journal of infection and chemotherapy : official journal of the Japan Society of Chemotherapy · 2015Trial
- Therapeutic drug monitoring of posaconazole in patients with acute myeloid leukemia or myelodysplastic syndrome.Antimicrobial agents and 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
- Skin concentrations and pharmacokinetics of posaconazole after oral administration.Antimicrobial agents and chemotherapy · 2010Trial
- 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
- Pharmacokinetics, safety, and efficacy of posaconazole in patients with persistent febrile neutropenia or refractory invasive fungal infection.Antimicrobial agents and chemotherapy · 2006Trial
- Oral bioavailability of posaconazole in fasted healthy subjects: comparison between three regimens and basis for clinical dosage recommendations.Clinical pharmacokinetics · 2005Trial
- Disposition of posaconazole following single-dose oral administration in healthy subjects.Antimicrobial agents and chemotherapy · 2004Trial
- Pharmacokinetics of posaconazole coadministered with antacid in fasting or nonfasting healthy men.Antimicrobial agents and chemotherapy · 2004Trial
- Effect of food on the relative bioavailability of two oral formulations of posaconazole in healthy adults.British journal of clinical pharmacology · 2004Trial
43 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.
Funding
No grant is acknowledged in the PubMed record.
Abstract
The pharmacokinetics, safety, and tolerability of posaconazole, an investigational triazole antifungal, were evaluated following the administration of rising single and multiple oral doses. A total of 103 healthy adults were enrolled in two phase I trials. Each study had a double-blind, placebo-controlled, parallel-group design with a rising single-dose (RSD) or rising multiple-dose (RMD) scheme. In the RSD study, subjects received single doses of posaconazole oral tablets (50 to 1200 mg) or placebo. In the RMD study, subjects received posaconazole oral tablets (50 to 400 mg) or placebo twice daily for 14 days. By using model-independent methods, the area under the plasma concentration-time curve and the maximum concentration in plasma were determined and used to assess dose proportionality. In the RSD study, the levels of posaconazole in plasma increased proportionally between the 50- and 800-mg dose range, with saturation of absorption occurring above 800 mg. Dose proportionality was also observed in the RMD study. In both studies, the apparent volume of distribution was large (range, 343 to 1341 liters) and the terminal-phase half-life was long (range, 25 to 31 h). Posaconazole was well tolerated at all dose levels, and the adverse events were not dose dependent. No clinically significant changes in clinical laboratory test values or electrocardiograms were observed. Following the administration of single and twice-daily rising doses, the level of posaconazole exposure increased in a dose-proportional manner. The long elimination-phase half-life of posaconazole supports once- or twice-daily dosing in clinical trials; however, additional studies are required to determine if further division of the dose will enhance exposure.
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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.