The pharmacokinetics and pharmacodynamics of prasugrel in healthy Chinese, Japanese, and Korean subjects compared with healthy Caucasian subjects.
Prasugrel is a novel thienopyridine prodrug metabolised to an active metabolite that binds irreversibly to the platelet P2Y12 receptor and inhibits adenosine diphosphate (ADP)-induced platelet aggregation. We compared prasugrel pharmacokinetics, pharmacodynamics, and tolerability in healthy Chinese,...
| Published in: | European Journal of Clinical Pharmacology Vol. 66; no. 2; pp. 127 - 136 |
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| Main Authors: | , , , , , , , , , , , |
| Format: | clinical trial equations & formulas research tables/charts Journal Article |
| Published: |
Springer Nature
Feb2010
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| Online Access: | View this record in EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=105292076&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 105292076 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 00316970 NP9 jtl: European Journal of Clinical Pharmacology issn: 00316970 maglogo: N pubinfo: dt: Feb2010 vid: 66 iid: 2 pid: 237 pub: Springer Nature place: New York, New York artinfo: ui: 105292076 2010536077 10.1007/s00228-009-0737-1 NLM19888568 105292076 ppf: 127 ppct: 9 formats: fmt: @attributes: type: P tig: atl: The pharmacokinetics and pharmacodynamics of prasugrel in healthy Chinese, Japanese, and Korean subjects compared with healthy Caucasian subjects. aug: au: Small DS Kothare P Yuen E Lachno DR Li YG Winters KJ Farid NA Ni L Jakubowski JA Salazar DE Thieu VT Payne CD affil: Lilly Research Laboratories, Eli Lilly and Company, Lilly Corporate Center Indianapolis 46285 USA sug: subj: Platelet Aggregation Inhibitors Pharmacokinetics Adult Asians Body Weight Clinical Trials Descriptive Statistics Female Funding Source Human Male Pharmacy and Pharmacology Platelet Aggregation Inhibitors Pharmacodynamics White Persons Adult: 19-44 years Female Male ab: Prasugrel is a novel thienopyridine prodrug metabolised to an active metabolite that binds irreversibly to the platelet P2Y12 receptor and inhibits adenosine diphosphate (ADP)-induced platelet aggregation. We compared prasugrel pharmacokinetics, pharmacodynamics, and tolerability in healthy Chinese, Japanese, Korean and Caucasian subjects. In an open-label, single-centre, parallel-design study, 89 healthy subjects (25 Chinese, 20 Japanese, 22 Korean and 22 Caucasian) aged 20-65 years were given a prasugrel 60-mg loading dose (LD) followed by daily 10-mg maintenance doses (MD) for 7 days and then 5-mg MD for 10 days. Plasma concentrations of prasugrel's active metabolite and inhibition of ADP-induced platelet aggregation (IPA) were determined. Mean exposure to prasugrel's active metabolite in all treatment regimens was higher in each of the Asian groups than in the Caucasian group, although there was considerable overlap between individual exposure estimates in Asians and Caucasians. The mean IPA was also higher in Asians than in Caucasians following a prasugrel 60-mg LD, although the difference did not consistently achieve statistical significance. Prasugrel 10-mg or 5-mg MD produced statistically significantly higher IPA in each Asian group compared with that in the Caucasians. Prasugrel was well tolerated during the LD and MD regimens by all groups. Mean exposure to the prasugrel active metabolite following prasugrel 60-mg LD and during daily 10-mg or 5-mg MD was higher in each of the Asian groups than in the Caucasian group, which resulted in greater platelet inhibition. pubtype: Academic Journal doctype: clinical trial equations & formulas research tables/charts Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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