| Emtricitabine PK Parameter |
Test
Formulation 1
(n = 34)a |
Reference
Formulation
(n = 34)a |
| Cmax (ng/mL), mean (%CV) |
1750 (23.6) |
1650 (21.9) |
| Tmax (hours), median (Q1, Q3) |
2.50 (2.00, 3.00) |
2.00 (2.00, 2.50) |
| Clast (ng/mL), mean (%CV) |
8.6 (35.0) |
8.2 (29.1) |
| Tlast (hours), median (Q1, Q3) |
72.0 (48.0, 72.0) |
72.0 (48.0, 72.0) |
| AUC0-last (ng•h/mL), mean (%CV) |
9420 (14.3) |
9420 (13.9) |
| AUCinf (ng•h/mL), mean (%CV) |
9640 (14.1) |
9640 (13.6) |
| %AUCexp, mean (%CV) |
2.3 (45.4) |
2.4 (49.7) |
| T1/2 (hours), median (Q1, Q3) |
18.3 (14.3, 20.2) |
19.0 (14.4, 20.8) |
%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. |
