Key result
Single 75 mg clopidogrel dose yields ~1.8 ng/ml peak plasma concentration in healthy Chinese men.
Why the study?
Ethnic variabilities exist in clopidogrel metabolism, and pharmacokinetic data from other populations may not extrapolate to Chinese individuals.
Observational (n=20)
No
This study establishes baseline pharmacokinetic parameters for a single 75 mg dose of clopidogrel in healthy Chinese male volunteers, highlighting potential ethnic differences in drug metabolism.
Clinicians should exercise caution extrapolating clopidogrel PK data to Chinese patients; leaves open dosing implications pending larger clinical trials.
There are marked ethnic variabilities in the metabolism of clopidogrel. The pharmacokinetic (PK) characteristics of clopidogrel have been studied previously in whites or Korean volunteers, but these PK characteristics may not be fully extrapolated to the Chinese people. Little is known about the PK characteristics of clopidogrel in Chinese population. The aim of this study was to evaluate the pharmacokinetic profiles of clopidogrel in 20 healthy Chinese volunteers after administration of a single dose of clopidogrel 75 mg. The peak plasma concentration (Cmax), time to Cmax(Tmax), area under the plasma concentration versus time curve from time 0 h to 36 h (AUC0–36), elimination half-life (t1/2), clearance rate (CL/F) and apparent volume of distribution (Vd) were (1.804 ± 1.706) ng/ml, (0.7 ± 0.3) h, (2.465 ± 1.693) ng · h/ml, (7.3 ± 7.0) h, (53.09 ± 34.65) × 103 L/h and (447.1 ± 440.8) × 103 L, respectively.
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Jian-jun et al. (2012) conducted an observational in Healthy volunteers (n=20). Clopidogrel was evaluated on Pharmacokinetic profiles (Cmax, AUC0-36). In healthy Chinese male volunteers, a single 75 mg dose of clopidogrel resulted in a mean peak plasma concentration of 1.804 ng/ml and an AUC0-36 of 2.465 ng·h/ml.
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