The marked inter-individual and ethnic variabilities in the metabolism of clopidogrel has been investigated.\r\nAlthough the pharmacokinetics (PK) of clopidogrel has been reported previously in Whites and Korean volunteers,\r\nthe PK characteristics may not be fully extrapolated to the Chinese population. Little is known about the PK\r\ncharacteristics and relative bioavailability of clopidogrel in Chinese population. The present study was to assess\r\nthe PK characteristics and relative bioavailability of clopidogrel in healthy Chinese volunteers. A single-dose,\r\nrandomized-sequence, open-label, 2-period crossover study was performed in fasting healthy Chinese male\r\nvolunteers. Eligible subjects were randomly assigned to receive a single 75-mg dose of the test or reference\r\nformulation of clopidogrel, followed by a 1-week washout period and administration of the alternate formulation. The\r\nplasma samples were collected and at 0 min (baseline), as well as at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 11, 14,\r\n24 and 36 hours, respectively, after drug administration. The concentrations of both clopidogrel and SR26334 were\r\ndetected by a validated liquid chromatography-tandem mass spectrometric method (LC-MS/MS). The formulations\r\nwere considered to be bioequivalent if the 90% CIs for the log-transformed values were within the predetermined\r\nequivalence range (80%ââ?¬â??125% for AUC and Cmax). For clopidogrel, the 90% CIs for the log-transformed ratios\r\nof Cmax and AUC0ââ?¬â??t were 90.26%ââ?¬â??113.91% and 91.82%ââ?¬â??103.27%, respectively. For SR26334, the 90% CIs were\r\n85.23%ââ?¬â??112.97% and 93.11%ââ?¬â??103.67%, respectively. In conclusion, the present results show that the formulation\r\nof clopidogrel was of bioequivalence to the reference, which have been tested in fasting, healthy, male Chinese\r\nvolunteers.
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