Table 1 Study characteristics used for model development of brivaracetam.
From: Investigating clinical pharmacokinetics of brivaracetam by using a pharmacokinetic modeling approach
Serial # | Study | N | Population | Gender | Age (years) | Weight (kg) | Dose (mg) | Route | Frequency |
|---|---|---|---|---|---|---|---|---|---|
Healthy IV study | |||||||||
1 | Stockis et al.21 | 25 | H | M/F | 18–55 | M ≥ 50 F ≥ 45 | 100 | IV bolus | Single dose |
Healthy oral studies | |||||||||
1 | Stockis et al.21 | 25 | H | M/F | 18–55 | M ≥ 50 F ≥ 45 | 10, 50, 75, 100 | Oral | OD |
2 | Stockis et al.22 | 14 | H | M | 18–55 | ≥ 50 | 200 | Oral | OD |
3 | Rolan et al.13 | 35 | H | M | 18–55 | ≥ 50 | 10, 20, 40, 80, 150, 300, 600, 1000, 1400 | Oral | OD |
4 | Stockis et al.23 | 42 | H | 19 M, 7 F | 38–72 | 70–80 | 100 | Oral | OD |
5 | Stockis et al.24 | 80 | H | M | 20–40 | N/M | 2.5–100 | Oral | Single dose |
2.5–50 | Multiple doses | ||||||||
Diseased studies | |||||||||
1 | Sargentini‐Maier et al.25 | 18 | CKD | M/F | 32–62 | 70–80 | 200 | Oral | OD |
2 | Stockis et al.23 | 42 | Liver cirrhosis | 19 M, 7 F | 38–72 | 70–80 | 100 | Oral | OD |
