| Tenofovir PK Parameter |
Test
Formulation 1
(n = 34)a |
Reference
Formulation
(n = 34)a |
| Cmax (ng/mL), mean (%CV) |
325 (26.0) |
291 (26.4) |
| Tmax (hours), median (Q1, Q3) |
2.00 (2.00, 2.50) |
1.50 (1.00, 2.00) |
| Clast (ng/mL), mean (%CV) |
7.9 (26.3) |
8.1 (29.4) |
| Tlast (hours), median (Q1, Q3) |
72.0 (72.0, 72.0) |
72.0 (48.0, 72.0) |
| AUC0-last (ng•h/mL), mean (%CV) |
3110 (21.1) |
3040 (21.3) |
| AUCinf (ng•h/mL), mean (%CV) |
3310 (19.7) |
3250 (19.7) |
| %AUCexp, mean (%CV) |
6.4 (32.7) |
6.6 (32.3) |
| T1/2 (hours), median (Q1, Q3) |
18.1 (16.6, 19.5) |
18.1 (16.8, 19.4) |
%CV = % coefficient of variation; PK = pharmacokinetic; Q1 = first interquartile; Q3 = third interquartile
Data presented in 3 significant figures.
a: Two subjects were excluded from the PK analysis set due to premature discontinuation from the study. |
