Table 4.
Predicted steady‐state pharmacokinetic parameters of ziprasidone during different periods of pregnancy (expressed as mean ± SD data)
| Parameters | Baselinea | 6 weeksa | 20 weeksa | 34 weeksa |
|---|---|---|---|---|
| Dose | 40 mg, b.i.d. | 40 mg, b.i.d. | 40 mg, b.i.d. | 40 mg, b.i.d. |
| fa | 0.81 ± 0.17 | 0.81 ± 0.17 | 0.81 ± 0.17 | 0.81 ± 0.17 |
| fu | 0.01007 ± 0.001 | 0.01038 ± 0.0010 | 0.01131 ± 0.0011 | 0.01285 ± 0.0012 |
| CLint (L h−1) | 3914.11 ± 1430.92 | 3690.45 ± 1503.84 | 3461.41 ± 1419.57 | 3115.07 ± 1264.15 |
| CL/F (L h−1)b | 69.94 ± 43.06 | 71.23 ± 51.71 | 74.41 ± 54.91 | 71.48 ± 49.36 |
| AUC0‐12h,SS (ng mL−1 h−1) | 655.39 ± 314.65 | 666.64 ± 349.45 | 641.00 ± 339.99 | 656.12 ± 332.99 |
| C max (ng mL−1) | 96.57 ± 43.24 | 92.11 ± 45.81 | 86.17 ± 43.19 | 85.99 ± 41.06 |
| C trough (ng mL−1) | 26.72 ± 16.12 | 29.74 ± 17.52 | 30.30 ± 17.61 | 32.36 ± 17.96 |
| t max (h) | 3.22 ± 0.70 | 3.32 ± 0.75 | 3.33 ± 0.76 | 3.34 ± 0.76 |
| Vss/F (L kg−1) | 1.15 ± 0.24 | 1.19 ± 0.22 | 1.29 ± 0.24 | 1.43 ± 0.26 |
AUC0‐12h,ss, area under the plasma concentration–time curve from 0–12 h at steady‐state; b.i.d., twice daily; CLint, intrinsic clearance; C max, maximum concentration; C trough, trough concentration; fa, fraction absorbed from dosage form; fu, fraction of drug unbound in plasma; Vss/F, apparent volume of distribution at steady‐state; t max, time to maximum concentration.
a
Baseline, non‐pregnant women; 6 weeks, first trimester pregnancy; 20 weeks, second trimester pregnancy; 34 weeks, third trimester pregnancy.
b
Clearance computed as F × Dose/AUC.