Parameter

Olanzapine

Test

Reference

% Geometric mean ratio,Test/Reference (90% CI)

Power

Cmax (ng/mL)

27.6 (8.45)

26.4 (8.45)

95.76 (88.55-103.55)

0.9978

AUC0-120 h (ng.h/mL)

835 (355)

805 (313)

103.77 (97.49-110.46)

0.9999

AUC0-∞ (ng.h/mL)

901 (408)

863 (366)

104.39 (98.20-110.98)

0.9999

Tmax (h)

3.53 (1.00-6.00)

3.00  (1.00-4.50)

 

 

T1/2 (h)

31.6 (5.18)

30.4 (5.32)

 

 

λz (h-1)

0.0222

0.023

 

 


AUC = area under plasma concentration-time curve, Cmax = maximal plasma concentration, Tmax = time for the maximal plasma concentration, T1/2 = half-life, λz = elimination rate constant. Data shown as geometric mean (SD) and median (range) for Tmax
Table 1: Pharmacokinetic parameters of olanzapine and bioequivalent analysis for the test (Olapin®) and reference (Zyprexa®) formulations.
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