Table 1.
Summary of calculated pharmacokinetic parameters of clopidogrel in the bioequivalence study (n=38)
| Parameters (unit) | Clopidogrel (test) | Plavix (reference) | Test/reference ratio |
|---|---|---|---|
| Geometric means (ranges) | |||
| Cmax (pg/mL) | 1,654.955 (681.197–5,142.327) | 1,606.476 (411.136–5,469.759) | 1.03 |
| AUC0→last (pg·h/mL) | 4,387.163 (1,369.817–11,754.935) | 4,335.747 (958.657–16,273.290) | 1.01 |
| AUC0→inf (pg·h/mL) | 4,711.904 (1,476.762–12,054.669) | 4,868.249 (1,061.579–16,859.625) | 9.68 |
| Medians (ranges) | |||
| Tmax (hours) | 0.75 (0.50–2.33) | 0.75 (0.25–2.00) | 1.00 |
| t1/2 (hours) | 4.66 (1.76–27.30) | 3.94 (2.10–85.37) | 1.18 |
Abbreviations: Cmax, peak plasma concentration; AUC, area under the drug’s plasma concentration–time curves; Tmax, time of peak plasma concentration; t1/2, elimination half-life.