Table 2.
Mean (CV%) values and 90% confidence intervals (CI) for oseltamivir pharmacokinetic parameters following administration of oseltamivir alone (Treatment A), oseltamivir with Maalox® (Treatment B) and oseltamivir with Titralac® (Treatment C).
| Oseltamivir Parameter | Treatment A (n = 12) Mean (CV%) | Treatment B (n = 12) Mean (CV%) | Treatment C (n = 12) Mean (CV%) | Ratio LSM Treatment B/A (90% CI) | Ratio LSM Treatment C/A (90% CI) |
|---|---|---|---|---|---|
| Cmax (ng ml−1) | 158 (40.6%) | 158 (46.9%) | 149 (38.2%) | 98.5 (72.8–133)** | 94.8 (70.1–128)** |
| AUC (0,∞) (ng ml−1 h) | 223 (19.1%) | 213 (27.5%) | 216 (17.1%) | 93.9 (83.9–105)* | 96.9 (86.7–108)* |
| AUC (0, last) (ng ml−1 h) | 219 (20.1%) | 208 (27.8%) | 212 (17.2%) | 93.7 (83.4–105)* | 97.1 (86.5–109)* |
| tmax (h) | 0.81 (47.5%) | 0.48 (34.9%) | 0.60 (64.7%) | N/A | N/A |
| tlag (h) | 0.02 (346.4%) | 0.02 (346.4%) | 0.08 (147.7%) | N/A | N/A |
| t1/2 (h) | 1.43 (37.9%) | 2.05 (31.2%) | 1.52 (34.1%) | N/A | N/A |
| CL/F (ml min−1) | 11600 (19.7%) | 12500 (25.1%) | 12000 (19.6%) | N/A | N/A |
| Ucum (0,24 h) (%) | 3.22 (20.2%) | 2.90 (42.1%) | 3.39 (16.0%) | N/A | N/A |
| CLR (0,24 h) (ml min−1) | 371 (21.0%) | 336 (32.9%) | 400 (16.9%) | N/A | N/A |
Treatment A = 150 mg oseltamivir alone, Treatment B = 150 mg oseltamivir plus 20 ml Maalox® suspension, Treatment C = 150 mg oseltamivir plus four Titralac® tablets. LSM = Least Square Means.
*
= 90% CI of the ratio of LSM falls within the ± 20% bioequivalence interval (80–125%)
**
= 90% CI of the ratio of LSM falls within the ± 30% bioequivalence interval (70–143%).
N/A = not applicable.