Trial reportClinical pharmacokinetics2006
Pharmacokinetics and pharmacodynamics of the oral direct thrombin inhibitor ximelagatran in young healthy Japanese men.
Trial report in Clinical pharmacokinetics, 2006. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 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
3 citing papers in PubMed, 7 citations in OpenAlex.
- Pharmacokinetic and pharmacodynamic data to be derived from early-phase drug development: designing informative human pharmacology studies.Clinical pharmacokinetics · 2008Review
- Should we tolerate tolerability as an objective in early drug development?British journal of clinical pharmacology · 2007Article
- No influence of food on the pharmacokinetics, pharmacodynamics or tolerability of the 24mg and 36mg oral tablet formulations of ximelagatran.Clinical drug investigation · 2005Article
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 2 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
BACKGROUND AND
objectiveThe direct thrombin inhibitor ximelagatran, which is rapidly bioconverted to its active form melagatran after oral administration, is being developed for the prevention and treatment of thromboembolism. This study assessed the effects of food and repeated dosing on the pharmacokinetics and pharmacodynamics of melagatran after oral administration of ximelagatran to young healthy Japanese males.
methodsIn part one of the two-part study, volunteers (n = 24) were randomised to receive in a crossover fashion a single oral dose of ximelagatran 48mg with or without breakfast on 2 days separated by a 2- to 7-day washout period. In the second part of the study, all volunteers received oral doses of ximelagatran 48mg every 12 hours for 5 days followed by a single dose on the morning of day 6.
resultsThe area under the plasma concentration-time curve (AUC), peak plasma concentration (C(max)) and urinary excretion of melagatran did not differ as a function of whether ximelagatran was taken with or without food. The relationship between the melagatran plasma concentration and activated partial thromboplastin time (aPTT, which reflects the thrombin inhibitory effect of melagatran) was also independent of concomitant food intake. During repeated dosing, steady-state plasma concentrations of melagatran were achieved after the second dose of ximelagatran on day 1 and remained stable through the rest of the dosing period. The melagatran AUC and C(max) increased slightly (by 18% and 22%, respectively) on day 6 compared with day 1. The interindividual variability in the melagatran AUC and C(max) remained low, as reflected by coefficients of variation of <20% on both day 1 and day 6. The amount of melagatran excreted in urine remained stable over the 6 days of repeated dosing.
conclusionThe pharmacokinetics, pharmacodynamics, safety and tolerability of melagatran after oral administration of ximelagatran were not affected by food or repeated dosing in healthy Japanese volunteers.
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