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NXY-059 does not af...
NXY-059 does not affect bleeding time in healthy volunteers : A randomized, double-blind, placebo-controlled, 3-period crossover phase I study
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Nilsson, Dag (author)
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Wemer, Johan (author)
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Cheng, Yi-Fang (author)
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Reinholdsson, Ingalill (author)
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- Englund, Gunnar (author)
- KTH,Matematisk statistik
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Egberg, Nils (author)
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- Schulman, Sam (author)
- Karolinska Institutet
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(creator_code:org_t)
- 2013-03-07
- 2007
- English.
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In: Journal of clinical pharmacology. - : Wiley. - 0091-2700 .- 1552-4604. ; 47:2, s. 264-272
- Related links:
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https://urn.kb.se/re...
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https://doi.org/10.1...
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http://kipublication...
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Abstract
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- NXY-059 is a novel free radical-trapping neuroprotectant that reduces infarct size and preserves brain function in animal models of acute ischemic stroke. It is the first neuroprotectant to demonstrate a reduction in global disability in a phase III clinical trial, as measured by the modified Rankin Scale. Any effect of NXY-059 on hemostasis may be important when treating stroke patients. This phase I randomized, double-blind, placebo-controlled, 3-period crossover study compared the effect of NXY-059, desmopressin, and placebo on bleeding time, platelet aggregation, and adhesion in 30 healthy volunteers. NXY-059 did not prolong bleeding time compared with placebo: mean (SD) time for NXY-059, 369.5 seconds (125.0 seconds) versus placebo, 369.1 seconds (136.0 seconds). There were no significant effects on platelet aggregation or adhesion. At a mean unbound plasma concentration (Cu-ss) of 335 mu mol/L, NXY-059 was well tolerated, with no major safety concerns identified. In conclusion, NXY-059 does not appear to affect primary hemostasis.
Keyword
- acute ischemic stroke
- bleeding
- neuroprotectant
- NXY-059
- pharmacokinetics
- acute ischemic-stroke
- tissue-plasminogen activator
- cerebral-ischemia
- desmopressin
- transient
- occlusion
- trials
- agent
- rat
Publication and Content Type
- ref (subject category)
- art (subject category)
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