Pharmacokinetic Parameter

Ref GeoLMS(*)

Test GeoLMS(*)

Ratio
(% Ref)

Classical
90%  CI

Two one-Sided t-test Schuirmann

Power

LnCmax
(ng/ml)

2399.36

2167.62

90.37

83.76 - 97.50

P(0<80%)=0.0051
P(0>125%)=0.0000

0.99

LnAUClast (ng*h/ml)

10700.50

10387.45

97.02

93.27 - 100.93

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

1.00

LnAUCinf (ng*h/ml)

11025.27

10704.50

97.04

93.41 - 100.82

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

1.00
(*) Geo LSM= Reference Geometric Least Squares Mean
Table 5: Bioequivalence analysis for 3TC following single-oral dose administration of either test (1 x 300 mg tablet) or reference treatment (2 x 150 mg tablet).
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