Table 5.
Comparison of plasma tramiprosate PK parameters following oral administration of tramiprosate as a modified-release tablet or loose-filled capsule, and ALZ-801 as a loose-filled capsule (i.e. Study 1, Substudy 3 in Table 1)
| PK parameter | Plasma tramiprosate after tramiprosate MR tablet 100 mg |
Plasma tramiprosate after tramiprosate LF capsule 100 mg |
Plasma tramiprosate after ALZ-801 LF capsule 172 mg |
|---|---|---|---|
| C max (ng/mL) | 506 ± 187 [12] | 769 ± 228 [12] | 628 ± 100 [12] |
| T max (h) | 4.50 [2.00–5.00] [12] | 1.00 [0.75–5.00] [12] | 2.00 [1.00–2.00] [12] |
| AUCt (ng/mL h) | 2355 ± 747 [12] | 3268 ± 1128 [12] | 2680 ± 448 [12] |
| AUCinf (ng/mL h) | 2037 ± 712 [6] | 3332 ± 1369 [8] | 2875 ± 492 [10] |
| λz (h−1) | 0.1826 ± 0.1025 [6] | 0.1846 ± 0.1020 [8] | 0.0494 ± 0.0128 [10] |
| t ½ (h) | 4.99 ± 2.66 [6] | 5.90 ± 5.22 [8] | 14.9 ± 3.97 [10] |
Data are expressed as mean ± SD [N], except for T max, which is reported as median [range] (N)
t ½: the elimination kinetics in some subjects could not be determined, thus the n is different for some of the PK parameters
PK pharmacokinetic, C max maximum concentration, T max time to reach Cmax, AUC t area under the concentration–time curve from time zero to time t, AUC inf area under the concentration–time curve from time zero to infinity, t ½ half-life, SD standard deviation, MR modified-release, LF loose-filled