Table 1 Summary of clinical studies employed in the development of Nicardipine PBPK model.

From: A PBPK modeling approach for personalized dose optimization of nicardipine in renal and hepatic dysfunction

Dosage

Study size

Gender

F Prop. (%)

Age (years)

References

Intravenous administration in healthy population

 0.16 mg/kg

14

M

0

21–40

33

 5 mg/ha

6

M

0

NN

34

 0.885 mg

6

M

0

24–33

35

 1.05 mg

1

F

100

32

36

 5 mg

8

M and F

50

51 ± 9

37

 210 ug/kgb

8

M

0

19–28

38

Oral administration in healthy population

 30 mg

6

M

0

NN

34

 40 mg

1

F

100

32

36

 30 mg

8

M

0

30–63

39

 20 mg

8

M and F

37.5

23–45

40

 30 mg

9

M and F

11.1

21–42

41

 20 mg

NN

NN

NN

NN

42

Oral administration in mild cirrhotic patients

 30 mg

9

M

0

31–66

39

Oral administration in chronic kidney disease

 20 mgc

12

M and F

33.3

19–75

41

 30 mgd

9

M and F

11.1

18–69

41

  1. M male, F female, Prop proportion, NN not narrated.
  2. aDose infused over 3 h, bdose infused over 30 min, cmoderate renal failure, dsevere renal impairment.