Trial reportEuropean journal of clinical pharmacology2004
Comparison of the pharmacokinetics of fosfluconazole and fluconazole after single intravenous administration of fosfluconazole in healthy Japanese and Caucasian volunteers.
Trial report in European 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 2 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
2 citing papers in PubMed, 13 citations in OpenAlex.
- The effects of hepatic impairment on the pharmacokinetics of fosfluconazole and fluconazole following a single intravenous bolus injection of fosfluconazole.British journal of clinical pharmacology · 2005Trial
- Fluconazole Population Pharmacokinetics after Fosfluconazole Administration and Dosing Optimization in Extremely Low-Birth-Weight Infants.Microbiology spectrum · 2022Article
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 4 institutions in 4 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesTo investigate the bioavailability of fluconazole (FLCZ) from fosfluconazole (phosphate pro-drug of FLCZ) and to compare the pharmacokinetics of fosfluconazole and FLCZ in Japanese and Caucasian subjects.
methodsIn a randomised, double-blind, double-dummy, single-dose, two-period, crossover study, 12 Japanese and 12 Caucasian healthy subjects received a bolus intravenous injection of 1000 mg fosfluconazole or an intravenous infusion of 800 mg FLCZ in random order. Concentrations of fosfluconazole and FLCZ were determined in plasma and urine samples taken up to 144 h and 48 h post-dose, respectively.
resultsThe bioavailability of FLCZ after administration of fosfluconazole was 95.2% (95% confidence interval: 89.0, 102.0) in Japanese subjects and 100.6% (94.0, 107.7) in Caucasian subjects. The ratio of bioavailabilities (Japanese/Caucasian) was 94.7% (86.0, 104.3). There were no statistically significant differences in the pharmacokinetic parameters of fosfluconazole (except for AUC(inf)) and FLCZ between Japanese and Caucasian subjects. Although mean AUC(inf) of fosfluconazole was 25.6% (5.6, 49.2) greater in Japanese subjects, the lack of a statistically significant difference in weight-adjusted CL of fosfluconazole demonstrates that the difference in AUC(inf) was due to a difference in body weight. The adverse-event profile was similar in Japanese and Caucasian subjects after both fosfluconazole and FLCZ dosing, and both treatments were well tolerated in each group.
conclusionsThe pharmacokinetics of fosfluconazole and FLCZ were similar in Japanese and Caucasian subjects. Fosfluconazole is almost completely converted to FLCZ and similar systemic exposure to FLCZ is achieved after single doses of fosfluconazole in both Japanese and Caucasian subjects.
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Registered trials
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