Study

Dose (mg)

Parameter (units)

Analyte

Adjusted Geometric Mean (SD)
Min; Max

Ratio (Test/Reference) of
Adjusted Geometric Mean (%)

90% Confidence Intervals (%)

Test

Reference

Lower

Upper

ST vs. MT

10

AUCinf (ng.h/mL)

ATV

16.73 (8.26)
5.90; 42.20

17.55 (8.80)
5.68; 51.40

95.34

91.33

99.52

AUClast (ng.h/mL)

ATV

14.02 (7.89)
4.42; 39.50

17.55 (8.72)
4.73; 48.20

95.79

91.07

100.76

Cmax (ng/mL)

ATV

2.34 (1.45)
0.78; 8.23

2.56 (1.23)
0.96; 5.97

91.41

83.39

100.20

ST vs. MT

80

AUCinf (ng.h/mL)

ATV

151.03 (100.78)
66.00; 794.00

152.88 (120.19)
57.90; 864.00

98.79

94.57

103.20

AUClast (ng.h/mL)

ATV

144.94 (100.57)
58.40; 786.00

146.81 (119.71)
51.80; 856.00

98.72

94.41

103.23

Cmax (ng/mL)

ATV

36.38 (31.71)
9.34; 193.00

34.76 (36.47)
7.25; 224.00

104.66

95.73

114.42

CT vs. MT

10

AUCinf (ng.h/mL)

ATV

22.78 (9.73)
9.05; 61.70

22.13 (9.68)
9.83; 65.80

102.91

99.02

106.96

O-ATV

24.46 (9.52)
10.10; 72.40

24.30 (9.67)
10.40; 70.50

100.64

97.51

103.88

AUClast (ng.h/mL)

ATV

20.48 (9.57)
7.31; 60.10

19.80 (9.26)
7.00; 64.30

103.48

99.34

107.79

O-ATV

16.73 (9.59)
7.52; 70.60

16.73 (9.71)
8.52; 68.40

101

97.68

104.44

Cmax (ng/mL)

ATV

3.80 (2.22)
1.45; 14.30

3.51 (1.58)
1.13; 8.70

108.13

98.75

118.40

O-ATV

1.49 (0.86)
0.48; 5.32

1.52 (0.91)
0.57; 5.54

97.98

92.34

103.96

CT vs. MT

80

AUCinf (ng.h/mL)

ATV

131.13 (58.71)
64.20; 364.00

124.03 (53.83)
60.00; 317.00

105.73

100.69

111.02

O-ATV

163.8 (75.99)
54.90; 514.00

156.5 (69.81)
64.70; 472.00

104.65

100.40

109.08

AUClst (ng.h/mL)

ATV

127.49 (59.13)
60.60; 363.00

120.79 (53.36)
57.60; 313.00

105.55

100.34

111.03

O-ATV

159.16 (74.69)
51.20; 492.00

151.88 (69.19)
61.40; 461.00

104.79

100.41

109.37

Cmax (ng/mL)

ATV

29.24 (15.88)
7.02; 91.50

28.85 (16.15)
9.27; 99.20

101.37

92.39

111.23

O-ATV

22.52 (15.82)
7.29; 95.30

22.28 (12.22)
6.60; 63.20

101.11

93.08

109.84

ATV=atorvastatin acid; O-ATV=ortho-hydroxyatorvastatin acid
Table 1: Statistical summary of pharmacokinetic parameters of atorvastatin and ortho-hydroxyatorvastatin in healthy subjects following single-dose administration of 10 and 80 mg doses as Small Tablet (ST) or Chew Tablet (CT) vs. Marketed Tablet (MT).
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