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.
Table 1: Summary of Emtricitabine Pharmacokinetic Parameters.
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