Table 2. Tacrolimus level results at each time point for individuals with a kidney or liver transplant.
| Individuals with a kidney transplant | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
PK time point (min/h) |
Innovator | Generic Hi | Generic Lo |
p-Value |
|||||||||
| First exposure | Second exposure | First exposure | Second exposure | First exposure | Second exposure | ||||||||
| Mean ng/ml | SD | Mean ng/ml | SD | Mean ng/ml | SD | Mean ng/ml | SD | Mean ng/ml | SD | Mean ng/ml | SD | ||
| 0 | 6.1 | 2.2 | 5.3 | 1.5 | 6.1 | 2.0 | 5.7 | 1.7 | 6.2 | 1.8 | 5.6 | 1.7 | 0.36 |
| 20 min | 6.5 | 2.5 | 5.8 | 2.0 | 6.8 | 2.3 | 6.9 | 4.0 | 7.4 | 3.3 | 6.8 | 3.0 | 0.25 |
| 40 min | 9.7 | 4.9 | 9.0 | 4.9 | 11.2 | 6.0 | 11.6 | 8.8 | 12.9 | 6.8 | 11.5 | 6.4 | 0.06 |
| 1 h | 12.2 | 7.4 | 12.3 | 8.4 | 14.7 | 9.2 | 13.7 | 7.6 | 16.0 | 8.0 | 13.9 | 6.7 | 0.11 |
| 80 min | 13.2 | 7.1 | 13.3 | 7.4 | 15.6 | 9.6 | 14.4 | 6.9 | 16.6 | 8.2 | 14.1 | 5.4 | 0.33 |
| 100 min | 14.0 | 8.2 | 13.3 | 5.9 | 15.6 | 8.7 | 13.9 | 5.8 | 16.0 | 8.1 | 13.4 | 4.5 | 0.72 |
| 2 h | 13.6 | 7.4 | 13.2 | 5.6 | 14.6 | 7.0 | 13.1 | 5.0 | 15.2 | 7.9 | 13.0 | 4.1 | 0.86 |
| 140 min | 13.1 | 6.7 | 12.7 | 5.0 | 14.5 | 6.5 | 12.1 | 4.5 | 14.3 | 7.3 | 12.0 | 3.6 | 0.76 |
| 160 min | 12.9 | 6.8 | 11.7 | 4.6 | 13.6 | 5.9 | 11.4 | 3.8 | 13.7 | 7.4 | 11.6 | 3.5 | 0.72 |
| 3 h | 12.3 | 5.9 | 11.0 | 3.7 | 12.6 | 5.2 | 11.0 | 3.9 | 13.1 | 7.0 | 11.0 | 3.6 | 0.79 |
| 4 h | 9.9 | 3.8 | 9.0 | 3.0 | 10.4 | 3.3 | 9.3 | 3.1 | 10.7 | 4.8 | 9.3 | 3.5 | 0.37 |
| 5 h | 8.2 | 3.0 | 7.7 | 2.3 | 8.8 | 2.7 | 8.0 | 2.4 | 8.9 | 3.2 | 7.8 | 2.3 | 0.44 |
| 6 h | 7.4 | 2.4 | 7.1 | 2.3 | 7.9 | 2.5 | 7.2 | 2.1 | 7.9 | 2.8 | 7.0 | 2.0 | 0.54 |
| 8 h | 6.6 | 2.2 | 6.2 | 1.9 | 6.9 | 2.2 | 6.2 | 1.6 | 6.9 | 2.3 | 6.2 | 1.7 | 0.50 |
| 12 h | 5.6 | 1.8 | 5.2 | 1.6 | 5.9 | 1.8 | 5.3 | 1.3 | 5.9 | 2.1 | 5.3 | 1.3 | 0.51 |
| Individuals with a liver transplant | |||||||||||||
| 0 | 4.1 | 1.6 | 3.9 | 1.5 | 4.3 | 1.7 | 4.5 | 2.5 | 4.2 | 1.7 | 4.2 | 1.7 | 0.90 |
| 20 min | 4.5 | 1.9 | 4.7 | 1.8 | 5.0 | 2.0 | 5.3 | 2.6 | 5.0 | 2.2 | 5.4 | 2.5 | 0.57 |
| 40 min | 7.7 | 4.4 | 7.8 | 4.5 | 9.7 | 4.9 | 9.5 | 5.6 | 9.1 | 4.9 | 10.9 | 6.6 | 0.18 |
| 1 h | 10.5 | 6.7 | 9.5 | 5.3 | 11.7 | 6.2 | 11.5 | 7.4 | 11.8 | 6.9 | 12.3 | 7.5 | 0.53 |
| 80 min | 11.4 | 6.6 | 9.9 | 5.4 | 11.4 | 6.1 | 11.4 | 7.3 | 12.4 | 7.8 | 11.3 | 6.0 | 0.85 |
| 100 min | 11.1 | 6.0 | 9.5 | 5.0 | 10.9 | 6.0 | 10.6 | 6.2 | 11.4 | 7.2 | 10.4 | 5.1 | 0.91 |
| 2 h | 10.5 | 5.2 | 8.9 | 4.5 | 10.2 | 5.9 | 9.4 | 5.2 | 10.7 | 6.7 | 9.5 | 4.3 | 0.80 |
| 140 min | 9.7 | 4.6 | 8.2 | 4.1 | 9.3 | 5.3 | 8.4 | 4.4 | 9.7 | 5.9 | 8.7 | 3.7 | 0.68 |
| 160 min | 8.8 | 4.0 | 7.6 | 3.8 | 8.5 | 4.7 | 7.8 | 3.9 | 9.1 | 5.4 | 8.0 | 3.4 | 0.72 |
| 3 h | 8.1 | 3.6 | 7.3 | 3.6 | 8.0 | 4.4 | 7.4 | 3.5 | 8.5 | 4.9 | 7.5 | 3.1 | 0.81 |
| 4 h | 6.4 | 2.7 | 6.1 | 3.1 | 6.5 | 3.3 | 6.4 | 2.8 | 6.9 | 3.7 | 6.2 | 2.4 | 0.89 |
| 5 h | 5.5 | 2.2 | 5.3 | 2.5 | 5.6 | 2.7 | 5.5 | 2.5 | 5.9 | 2.8 | 5.4 | 2.0 | 0.95 |
| 6 h | 4.9 | 1.9 | 4.7 | 2.1 | 5.1 | 2.3 | 5.1 | 2.4 | 5.4 | 2.4 | 4.9 | 1.9 | 0.88 |
| 8 h | 4.3 | 1.7 | 4.2 | 1.8 | 4.6 | 2.1 | 4.5 | 2.0 | 4.7 | 2.1 | 4.4 | 1.7 | 0.92 |
| 12 h | 3.7 | 1.5 | 3.6 | 1.5 | 3.9 | 1.7 | 3.9 | 1.8 | 3.9 | 1.8 | 3.7 | 1.4 | 0.96 |
PK, pharmacokinetics; SD, standard deviation.