Table 3:
Statistical comparison of secondary PK parameters for tacrolimus and cyclosporin (PK analysis set).
| Pairwise comparison | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Cohort | Drug | Parameter (unit) | Treatment | N | n | Geometric LSM | 90% CI | Pair | Ratio (%) | 90% CI |
| 1 | Tacrolimus | AUClast (h*pg/mL) | T | 31 | 31 | 241 500 | 209 100–278 800 | |||
| T + SZC | 30 | 30 | 158 300 | 136 900–183 000 | T + SZC/T | 65.57 | 58.69–73.24 | |||
| t½λz (h) | T | 31 | 31 | 33.65 | 31.71–35.71 | |||||
| T + SZC | 30 | 30 | 33.12 | 31.20–35.16 | T + SZC/T | 98.42 | 94.62–102.40 | |||
| Tmax (h) | T | 31 | 31 | 1.810 | 1.640–1.998 | |||||
| T + SZC | 30 | 30 | 1.518 | 1.373–1.678 | T + SZC/T | 83.86 | 73.38–95.84 | |||
| 2 | Cyclosporin | AUClast (h*pg/mL) | C | 31 | 31 | 1792 | 1659–1935 | |||
| C + SZC | 29 | 29 | 1739 | 1609–1880 | C + SZC/C | 97.04 | 92.70–101.60 | |||
| t½λz (h) | C | 31 | 31 | 9.211 | 8.373–10.13 | |||||
| C + SZC | 29 | 29 | 8.669 | 7.863–9.559 | C + SZC/C | 94.12 | 85.74–103.30 | |||
| Tmax (h) | C | 31 | 31 | 1.417 | 1.303–1.541 | |||||
| C + SZC | 29 | 29 | 1.382 | 1.268–1.507 | C + SZC/C | 97.55 | 87.16–109.20 | |||
Treatment T, tacrolimus 5 mg; Treatment T + SZC, tacrolimus 5 mg + SZC 15 g; Treatment C, cyclosporin 100 mg; Treatment C + SZC, cyclosporin 100 mg + SZC 15 g.
Results are based on a mixed effect following a natural logarithmic transformation of the individual PK parameters, with period, treatment and sequence as fixed effects, and subject nested within sequence as random effect.
Geometric LSM ratio and corresponding CI are back-transformed and presented as percentages. Geometric LSM and corresponding 90% CI are also back-transformed.
N, all participants in the pharmacokinetic analysis set and statistical comparison analysis; n, all participants included in the statistical comparison analysis.