Test Formulation (n = 24)

Pharmacokinetic parameters

Mean

Median

Geometric Mean

SD

CV (%)

Max

Min

Cmax (μg/ml)

1.45

1.46

1.35

0.53

36.58

2.28

0.67

Tmax (hr)

2.25

2.50

2.17

0.57

25.51

3.00

1.00

AUC0-12 (hr-μg/ml)

4.38

4.42

3.96

2.04

46.44

8.21

2.08

AUC0-¥ (hr-μg/ml)

4.59

4.69

4.19

1.99

43.31

8.23

2.15

kel (hr-1)

0.35

0.37

0.33

0.11

30.83

0.47

0.16

AUMC0-12 (hr2-μg/ml)

18.65

19.71

16.54

8.96

48.03

35.65

6.03

AUMC0-∞  (hr2-μg/ml)

21.93

21.39

19.81

8.92

40.68

35.93

6.78

t1/2 (hr)

2.24

1.85

2.10

0.93

41.55

4.20

1.47

MRT (hr)

4.86

4.49

4.73

1.22

25.20

7.49

3.16

Reference Formulation (n = 24)

Pharmacokinetic parameters

Mean

Median

Geometric Mean

SD

CV (%)

Max

Min

Cmax (μg/ml)

1.53

1.57

1.46

0.47

30.74

2.23

0.80

Tmax (hr)

2.21

2.00

2.10

0.71

31.96

3.50

1.00

AUC0-12 (hr-μg/ml)

4.37

3.50

3.86

2.35

53.78

9.47

1.90

AUC0-∞ (hr-μg/ml)

4.62

3.56

4.11

2.39

51.77

9.48

2.00

kel (hr-1)

0.39

0.36

0.35

0.18

45.94

0.77

0.17

AUMC0-12 (hr2-μg/ml)

18.05

12.40

15.21

11.34

62.83

39.69

5.86

AUMC0-∞  (hr2-μg/ml)

22.05

15.87

18.73

12.91

58.53

41.69

7.31

t1/2 (hr)

2.16

1.95

1.96

0.97

45.18

4.12

0.90

MRT (hr)

4.69

4.43

4.56

1.25

26.56

7.42

3.47

Table 1: Serum pharmacokinetic parameters of all the volunteers for test and reference formulations.
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