Rilpivirine PK Parameter |
Test
Formulation 1
(n = 34)a |
Reference
Formulation
(n = 34)a |
Cmax (ng/mL), mean (%CV) |
116 (29.6) |
99.8 (30.5) |
Tmax (hours), median (Q1, Q3) |
4.50 (4.00, 4.50) |
4.50 (4.00, 4.50) |
Clast (ng/mL), mean (%CV) |
4.1 (72.9) |
3.4 (72.8) |
Tlast (hours), median (Q1, Q3) |
192 (192, 193) |
192 (192, 192) |
AUC0-last (ng•h/mL), mean (%CV) |
3010 (34.5) |
2600 (32.5) |
AUCinf (ng•h/mL), mean (%CV) |
3390 (39.4) |
2920 (38.6) |
%AUCexp, mean (%CV) |
9.5 (68.5) |
9.6 (69.3) |
T1/2 (hours), median (Q1, Q3) |
54.2 (39.0, 62.9) |
53.1 (40.2, 65.5) |
%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. |