Table 3:
Raw Pharmacokinetic Parameters and Subject Specifics
| Drug | Subjects (n) | Primary Sex | Primary Race(s) | Median BMI (kg/m2), (SD) | Median Age (yrs), (SD) | Total Dose (mg) | # Doses | Time of Administration | Cmax (ng/mL), mean (CV%) | Tmax (hrs) | AUC(0-∞) (h*ng/mL), mean (CV%) |
|---|---|---|---|---|---|---|---|---|---|---|---|
|
| |||||||||||
| Epidiolex | |||||||||||
|
| |||||||||||
| A1 | 38 | M | Caucasian | 25.9 (2.7) | 37.7 (8.9) | 750 | 1 | Morning | 336.2 (46.7) | 5.116 | 1683.3 (46.7) |
| A2 | 39 | M | Caucasian | 25.9 (2.7) | 37.7 (8.9) | 1500 | 1 | Morning | 524.5 (64.9) | 6.133 | 2713 (64) |
| A3 | 40 | M | Caucasian | 25.9 (2.7) | 37.7 (8.9) | 4500 | 1 | Morning | 426.9 (112.8) | 4.067 | 2290.3 (104.1) |
| B1 | 15 | M | Caucasian/Multiple | 24.81 (3.52) | 27.7 (8.2) | 1500 | 2 | Morning & Evening | 840 (61.1) | 5 | - |
| B2 | 12 | M/F | Caucasian | 25.71 (3.52) | 35.1 (12.9) | 1500 | 2 | Morning & Evening | 852 (57.3) | 4.5 | - |
| B3 | 14 | M | Caucasian | 23.21 (2.22) | 29.9 (10.5) | 1500 | 2 | Morning & Evening | 838 (39.8) | 5 | - |
| H1 | 6 | M/F | Caucasian | 23.73 (2.45) | 26 (3.2) | 1500 | 1 | Morning | 292.4 (87.9) | 4 | 1618 (74.6) |
| H2 | 6 | M/F | Caucasian | 23.15 (2.33) | 25 (4.7) | 3000 | 1 | Morning | 533 (35.1) | 5 | 2802 (35.5) |
| H3 | 6 | M/F | Caucasian | 21.38 (1.71) | 25.8 (7.9) | 4500 | 1 | Morning | 722.1 (52.3) | 5 | 3426 (48.3) |
| H4 | 6 | M/F | Caucasian | 23.6 (2.53) | 22.8 (3.2) | 6000 | 1 | Morning | 782 (83) | 5 | 3900 (79.3) |
| H5 | 12 | M/F | Caucasian | 23.34 (1.9) | 25.1 (6.2) | 1500 | 1 | Morning | 335.4 (81.3) | 3.5 | 2198 (48.2) |
| H6 | 12 | M/F | Caucasian | 23.34 (1.9) | 25.1 (6.2) | 1500 | 1 | Morning | 1628 (51.4) | 3 | 8669 (33.9) |
| H7 | 9 | M/F | Caucasian | 22.28 (3.03) | 28.6 (8.5) | 750 | 13 | Morning and Evening (6 days), Morning dose on 7th day | Day 1 am: 290.8 (86.3), Day 1 pm: 732.4 (39.4), Day 7 am: 330.3 (40.8) | Day 1 am: 5, Day 1 pm: 2.5, Day 7 am: 3 | - |
| H8 | 9 | M/F | Caucasian/Multiple | 22.23 (2.33) | 25.1 (4.8) | 1500 | 13 | Morning and Evening (6 days), Morning dose on 7th day | Day 1 am: 361.8 (105.8), Day 1 pm: 1385 (52.4), Day 7 am: 541.2 (53.7) | Day 1 am: 5, Day 1 pm: 4, Day 7 am: 3 | - |
| L1 | 8 | M/F | Caucasian | 25.8 (5.7) | 57.5 (8.1) | 200 | 1 | Morning | 233 (70.5) | 2.8 | 699 (44.2) |
| L2 | 8 | M/F | Caucasian | 29.6 (3.8) | 55.6 (11.1) | 200 | 1 | Morning | 354 (42.3) | 2 | 1163 (39.9) |
| L3 | 6 | M/F | Caucasian | 30.0 (4.7) | 52.7 (6.9) | 200 | 1 | Morning | 381 (52.5) | 2.5 | 2439 (29.5) |
| L4 | 8 | M/F | Caucasian | 29.4 (3.2) | 55 (10) | 200 | 1 | Morning | 148 (65) | 2.3 | 474 (73.8) |
| M1 | 8 | M/F | Caucasian/Black | 90 kg | 49 | 300 | 1 | Morning | 9.0 (33.33) | 3.2 | 159 (49.06) |
| M2 | 8 | M/F | Caucasian/Black | 90 kg | 49 | 300 | 1 | Morning | 135 (66.67) | 2.4 | 771 (62.26) |
| Oral Capsule | |||||||||||
|
| |||||||||||
| C | 8 | M/F | Black/Caucasian/Mixed | - | 29.1 (9.1) | 800 | 1 | Morning | 77.9 | 3 | - |
| D1 | 9 | M | - | - | 25 | 10 | 1 | Dosed 4h and 8h after meal | 0.5 (20) | 3.1 (12.90) | |
| E1 | 6 | M/F | Black/Caucasian | - | 38.5 (2.2) | 400 | 1 | Morning | 181.2 (21.96) | 3 | 7040 (40.2) |
| E2 | 6 | M/F | Black/Caucasian | - | 38.5 (2.2) | 800 | 1 | Morning | 221.1 (16.10) | 3 | 8670 (35.06) |
| F4 | 12 | M/F | Caucasian | 24.33 (1.8) | 36.5 (8.38) | 10 | 1 | Morning | 2.47 | 1.267 | 362.04 |
| I1 | 12 | M | - | 25 (2) | 24 (4) | 45 | 1 | Morning | 16.8 (66.67) | 1.883 | 2252 (45.49) |
| I2 | 12 | M | - | 25 (2) | 24 (4) | 90 | 1 | Morning | 54.6 (43.04) | 2.05 | 7115 (41.86) |
| I3 | 12 | M | - | 25 (2) | 24 (4) | 45 | 1 | Morning | 21.2 (45.75) | 2.167 | 2860 (45.49) |
| I4 | 12 | M | 25 (2) | 24 (4) | 90 | 1 | Morning | 77.6 (52.32) | 1.833 | 10,865 (58.19) | |
| J1 | 13 | M | Caucasian | 24.8 | 30.7 | 10 | 1 | Morning | 3.22 (39.62) | 3 | 10.31 (40.14) |
| J2 | 13 | M | Caucasian | 24.8 | 30.7 | 100 | 1 | Morning | 47.44 (42.35) | 3.5 | 153.04 (22.67) |
| Sativex | |||||||||||
|
| |||||||||||
| D2 | 9 | M | - | - | 25 | 10 | 1 | Dosed 4h and 8h after meal | 2.1 (19.05) | 1 | 6.9 (18.84) |
| F1 | 12 | M/F | Caucasian | 24.33 (1.8) | 36.5 (8.38) | 10 | 1 | Moming | 2.5 | 1.633 | 427.33 |
| F2 | 12 | M/F | Caucasian | 24.33 (1.8) | 36.5 (8.38) | 10 | 1 | Morning | 3.02 | 2.8 | 407.79 |
| F3 | 12 | M/F | Caucasian | 24.33 (1.8) | 36.5 (8.38) | 10 | 1 | Morning | 2.61 | 2.05 | 496.98 |
| G | 12 | M/F | - | - | - | 10 | 1 | - | 5.4 (57.3) | 1 | - |
| J3 | 13 | M | Caucasian | 24.8 | 30.7 | 10 | 1 | Morning | 2.05 (53.83) | 3.5 | 7.81 (35.96) |
| K1 | 6 | M | Caucasian/Black/Asian | 23.5 | 32 | 5 | 1 | Morning | 0.39 (20.51) | 1 | 1.66 (30.72) |
| K2 | 12 | M | Caucasian/Black/Asian | 23.5 | 32 | 10 | 1 | Morning | 1.15 (64.35) | 1.39 | 5.64 (72.52) |
| K3 | 6 | M | Caucasian/Black/Asian | 23.5 | 32 | 20 | 1 | Morning | 2.17 (56.68) | 1 | 13.28 (96.84) |
| K4 | 6 | M | Caucasian/Black/Asian | 23.5 | 32 | 5 | 9 | Morning, 9 days | 0.49 (42.86) | 1.64 | 2.52 (28.97) |
| K5 | 12 | M | Caucasian/Black/Asian | 23.5 | 32 | 10 | 9 | Moming, 9 days | 1.14 (75.44) | 1.27 | 6.66 (46.55) |
| K6 | 6 | M | Caucasian/Black/Asian | 23.5 | 32 | 20 | 9 | Moming, 9 days | 3.22 (59.01) | 2 | 20.34 (35.84) |
| N | 24 | M | - | 24.5 | 34 | 10 | 1 | Moming | 3.33 | 4.22 | 43107.6 |
All data collected from clinical trials and categorized by Epidiolex, Sativex, or oral capsule