Pharmacokinetic Parameter

Ref GeoLMS(*)

Test GeoLMS(*)

Ratio
(% Ref)

Classical 90%  CI

Two one-Sided t-test Schuirmann

Power

LnCmax
(ng/ml)

225.21

227.22

100.99

92.89 - 109.80

P(0<80%)=0.0000
P(0>125%)=0.0001

0.99

LnAUClast (ng*h/ml)

1528.89

1470.23

96.11

90.02 - 102.63

P(0<80%)=0.0000
P(0>125%)=0.0000

0.99

LnAUCinf  (ng*h/ml)

1859.83

1763.12

94.73

88.22 - 101.73

P(0<80%)=0.0001
P(0>125%)=0.0000

0.99

(*) Geo LSM= Geometric Least Squares Mean
Table 4: Bioequivalence analysis for TFV following single-oral dose administration of either test (1 x 300 mg tablet) or reference treatment (1 x 300 mg tablet).
Goto home»