Trial reportAntimicrobial agents and chemotherapy2006
Pharmacokinetics of itraconazole and hydroxyitraconazole in healthy subjects after single and multiple doses of a novel formulation.
Trial report in Antimicrobial agents and chemotherapy, 2006. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers.
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
19 citing papers in PubMed, 75 citations in OpenAlex.
- Repurposing antifungals: population pharmacokinetics of itraconazole and hydroxy-itraconazole following administration of a nanocrystal formulation.The Journal of antimicrobial chemotherapy · 2023Trial
- Efficacy of Super-Bioavailable Itraconazole and Conventional Itraconazole at Different Dosing Regimens in Glabrous Tinea Infection - A Randomized Clinical Trial.Drug design, development and therapy · 2023Trial
- 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
- Assessing Impact of Food on Oral Drug Bioequivalence Supporting ICH M13 A with the Advancements of Physiologically Based Pharmacokinetic Modeling.Pharmaceutical research · 2025Article
- Diverse antifungal potency of terbinafine as a therapeutic agent against Exophiala dermatitidis in vitro.Scientific reports · 2024Article
- Triazole Antifungal Quantification for Therapeutic Drug Monitoring in Serum by Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS): Posaconazole, Voriconazole, Itraconazole, and Hydroxyitraconazole.Methods in molecular biology (Clifton, N.J.) · 2024Article
- Conversion of raltegravir carrying a 1,3,4-oxadiazole ring to a hydrolysis product upon pH changes decreases its antiviral activity.PNAS nexus · 2024Article
- Diagnosis and clinical management ofMedical mycology case reports · 2023Article
- New In Vitro-In Silico Approach for the Prediction of In Vivo Performance of Drug Combinations.Molecules (Basel, Switzerland) · 2021Article
- Nanotechnology as a Platform for the Development of Injectable Parenteral Formulations: A Comprehensive Review of the Know-Hows and State of the Art.Pharmaceutics · 2020Review
- Administration and Dosing of Systemic Antifungal Agents in Pediatric Patients.Paediatric drugs · 2020Review
- Recommendations for the Design of Clinical Drug-Drug Interaction Studies With Itraconazole Using a Mechanistic Physiologically-Based Pharmacokinetic Model.CPT: pharmacometrics & systems pharmacology · 2019Article
- Sustained delivery of a camptothecin prodrug - CZ48 by nanosuspensions with improved pharmacokinetics and enhanced anticancer activity.International journal of nanomedicine · 2019Article
- Population in vitro-in vivo pharmacokinetic model of first-pass metabolism: itraconazole and hydroxy-itraconazole.Journal of pharmacokinetics and pharmacodynamics · 2018Article
- High drug-loading nanomedicines: progress, current status, and prospects.International journal of nanomedicine · 2017Review
- Development of a Physiologically Based Pharmacokinetic Model for Itraconazole Pharmacokinetics and Drug-Drug Interaction Prediction.Clinical pharmacokinetics · 2016Article
- Insoluble drug delivery strategies: review of recent advances and business prospects.Acta pharmaceutica Sinica. B · 2015Review
- Elucidating the in vivo fate of nanocrystals using a physiologically based pharmacokinetic model: a case study with the anticancer agent SNX-2112.International journal of nanomedicine · 2015Article
- Development of PLGA-based itraconazole injectable nanospheres for sustained release.International journal of nanomedicine · 2013Article
Corrections and comments
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Authors and funding
6 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Originally, itraconazole for parenteral administration was licensed in a 40% hydroxypropyl-beta-cyclodextrin (HPBCD) solution for intravenous administration. A novel formulation, the NanoCrystal formulation (NCF), was prepared. NCF consists of drug particles of approximately 200 to 300 nm. The pharmacokinetics of itraconazole and its hydroxy metabolite in healthy subjects were evaluated after single and multiple doses of itraconazole as NCF. In the single-ascending-dose (SAD) study, itraconazole doses were planned to range from 50 to 500 mg, while in the multiple-ascending-dose (MAD) study, itraconazole doses of 100, 200, and 300 mg as NCF were studied, as was one dose level (200 mg) as an HBPCD solution. Samples were collected in heparinized tubes at various time points and were analyzed by high-performance liquid chromatography to allow full pharmacokinetic analysis both after the first dose and on day 7. The results of both the SAD and the MAD studies indicated that there was a dose dependency in the half-life of itraconazole from the novel formulation, increasing from 44 h (100 mg) to more than 150 h (300 mg) once steady state was achieved. Similar dose-dependent effects were observed for the hydroxy metabolite. The areas under the concentration-time curves for itraconazole and hydroxyitraconazole were also dose dependent. The pharmacokinetic profiles after 200-mg doses of itraconazole as NCF and HPBCD formulations were comparable with respect to the terminal half-life, both after a single dose and at steady state. NCF may provide an alternative to the HPBCD solution for the further optimization of antifungal treatment with itraconazole.
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Registered trials
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