Table 1 Summary of clinical studies employed in the development of Nicardipine PBPK model.
Dosage | Study size | Gender | F Prop. (%) | Age (years) | References |
---|---|---|---|---|---|
Intravenous administration in healthy population | |||||
0.16 mg/kg | 14 | M | 0 | 21–40 | |
5 mg/ha | 6 | M | 0 | NN | |
0.885 mg | 6 | M | 0 | 24–33 | |
1.05 mg | 1 | F | 100 | 32 | |
5 mg | 8 | M and F | 50 | 51 ± 9 | |
210 ug/kgb | 8 | M | 0 | 19–28 | |
Oral administration in healthy population | |||||
30 mg | 6 | M | 0 | NN | |
40 mg | 1 | F | 100 | 32 | |
30 mg | 8 | M | 0 | 30–63 | |
20 mg | 8 | M and F | 37.5 | 23–45 | |
30 mg | 9 | M and F | 11.1 | 21–42 | |
20 mg | NN | NN | NN | NN | |
Oral administration in mild cirrhotic patients | |||||
30 mg | 9 | M | 0 | 31–66 | |
Oral administration in chronic kidney disease | |||||
20 mgc | 12 | M and F | 33.3 | 19–75 | |
30 mgd | 9 | M and F | 11.1 | 18–69 |