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.
Table 3: Summary of Tenofovir Pharmacokinetic Parameters.
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