Trial reportClinical pharmacokinetics2003
No influence of ethnic origin on the pharmacokinetics and pharmacodynamics of melagatran following oral administration of ximelagatran, a novel oral direct thrombin inhibitor, to healthy male volunteers.
Trial report in Clinical pharmacokinetics, 2003. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 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.
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Who cites it
14 citing papers in PubMed, 63 citations in OpenAlex.
- Pharmacokinetics and pharmacodynamics of the oral direct thrombin inhibitor ximelagatran in young healthy Japanese men.Clinical pharmacokinetics · 2006Trial
- Comparable pharmacokinetics and pharmacodynamics of melagatran in Japanese and caucasian volunteers after oral administration of the direct thrombin inhibitor ximelagatran.Clinical pharmacokinetics · 2006Trial
- No influence of mild-to-moderate hepatic impairment on the pharmacokinetics and pharmacodynamics of ximelagatran, an oral direct thrombin inhibitor.Clinical pharmacokinetics · 2003Trial
- Advancing Wider Implementation of Multi-regional Clinical Trials in East Asia.Therapeutic innovation & regulatory science · 2026Review
- Ximelagatran: direct thrombin inhibitor.Vascular health and risk management · 2006Review
- Direct thrombin inhibitors: novel antithrombotics on the horizon in the thromboprophylactic management of atrial fibrillation.Postgraduate medical journal · 2005Review
- No influence of food on the pharmacokinetics, pharmacodynamics or tolerability of the 24mg and 36mg oral tablet formulations of ximelagatran.Clinical drug investigation · 2005Article
- Comparative pharmacokinetics of vitamin K antagonists: warfarin, phenprocoumon and acenocoumarol.Clinical pharmacokinetics · 2005Review
- New approaches to anticoagulation in atrial fibrillation.Current cardiology reports · 2004Review
- Anticoagulation for non-valvular atrial aibrillation - towards a new beginning with ximelagatran.Current controlled trials in cardiovascular medicine · 2004Article
- Oral direct thrombin inhibition: an effective and novel approach for venous thromboembolism.Drugs · 2004Review
- Review
- Review
- A review of the clinical uses of ximelagatran in thrombosis syndromes.Journal of thrombosis and thrombolysis · 2003Review
Corrections and comments
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Authors and funding
5 authors at 1 institution in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveTo determine the influence of ethnic origin on the pharmacokinetic and pharmacodynamic properties of melagatran after oral administration of ximelagatran, a novel oral direct thrombin inhibitor. STUDY
designThis was an open-label, non-randomised study with a single study session. SUBJECTS: Thirty-six young healthy male subjects living in France were divided equally according to their ethnic origin (African, Asian and Caucasian).
methodsAll subjects received a single 50mg oral dose of ximelagatran in solution. Blood and urine samples for pharmacokinetic evaluation were collected up to 12 and 24 hours after administration, respectively. Blood samples were also collected to determine the activated partial thromboplastin time (APTT), an ex vivo coagulation time measurement used to demonstrate inhibition of thrombin, up to 24 hours after administration.
resultsThe absorption of ximelagatran, and its bioconversion to melagatran, was rapid in all three ethnic groups. The metabolite pattern in plasma and urine was similar in all groups, with melagatran being the dominant compound. For ximelagatran, the mean area under the plasma concentration-time curve (AUC) was similar in the three groups, suggesting that there was no difference in the extent to which ximelagatran was absorbed. Melagatran AUC was higher in the Asian subjects, with a mean Asian/Caucasian ratio (95% CI) of 1.23 (1.04, 1.45). This was presumably because of their lower bodyweight, which is correlated to lower renal function. Following normalisation for bodyweight, there were no statistically significant differences between the three ethnic groups. This finding suggests that renal elimination was lower for Asian subjects, whereas there were no differences in the conversion of ximelagatran to melagatran. The interindividual variability of melagatran AUC was low (coefficient of variation 19-26%), and the mean bioavailability of melagatran, estimated using a mean value for melagatran clearance obtained from Caucasian subjects in a previous study, was approximately 20% in all groups (range of mean values 19-23%). APTT increased nonlinearly with increasing melagatran plasma concentration, and no difference in the concentration-response relationship was observed between the groups.
conclusionsAfter oral administration of ximelagatran, the pharmacokinetic and pharmacodynamic properties of melagatran are independent of ethnic origin. The elimination of melagatran is correlated with renal function.
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