Parameters Product

Fasting  study

Non-fasting  study

Cmax (ng/mL)

AUC0-t (ng.h/mL)

AUC0-∞ (ng.h/mL)

Cmax (ng/mL)

AUC0-t (ng.h/mL)

AUC0-∞
(ng.h/mL)
Geometric Mean

Test (A)

1158.124

5417.395

5789.848

1387.719

6285.006

6523.251

Reference B)

1227.654

5562.313

5890.051

1409.831

6793.396

7057.526
Least Square Mean (LSM)

Test (A)

1100.218

5146.525

5500.356

1339.339

5970.755

6197.088

Reference(B)

1166.271

5284.197

5595.548

1318.333

6453.726

6704.65
LSM Ration A/B %  

94.34

97.39

98.30

98.43

92.52

92.43
90% Confidence Interval : A/B        

 
           Lower Limit  

97.82

87.22

86.45

96.28

86.39

86.29
          Upper Limit  

102.01

113.34

100.78

110.16

102.15

101.42
P – value (ANOVA)
Period           
Formulation                                     
        Sequence
 

0.7251
0.9077
0.0562

0.7701
0.9981
0.0217

0.1303
0.7624
0.0142

0.4266
0.5238
0.9900

0.6594
0.7722
0.4586

0.4148
0.8947
0.0567
Intra-subject Variability: (CV%)  

14.10

16.04

14.7

18.52

17.02

16.39
Power (%)  

99.99

98.73

99.46

98.96

99.54

99.69
Untransformed Tmax (p-value)
(Wilcoxon signed rank test)
 

0.9473

0.9727

Note: A= Test Product and B=Reference Product; CV = Coefficient of Variance
Table 3: Summary statistics of acyclovir in subjects under fasting and non-fasting conditions.
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