Table 1:
Administration Methods and Meal Contents
| Data Points | Drug | Fasted/Fed | Administration Time | FDA Guidance | Caloric Content (kcal) | Fat Content (g) | Published | Nation | Reference |
|---|---|---|---|---|---|---|---|---|---|
| A1-A3 | Epidiolex | Fasted | Dose given after an overnight fast | Yes | 0 | 0 | 3-Oct-18 | Canada | 21 |
| B1-B3 | Epidiolex | Fed | Dosed 30 mins after meal, evening dose given 12h after | Yes | 574 | 26.4 | 21-Feb-19 | Netherlands | 19 |
| C | Oral Capsule | Fed | Dosed 30 mins after light meal following an overnight fast | Yes | 450 | 12.5 | 10-Feb-16 | USA | 22 |
| D1 | Oral Capsule | Fed | Dosed 4h and 8h after meal | No | 574 | 26.4 | 28-Nov-17 | Israel | 3 |
| D2 | Sativex | Fed | Dosed 4h and 8h after meal | No | 574 | 26.4 | 28-Nov-17 | Israel | 3 |
| E1 - E2 | Oral Capsule | Fed | Dosed 2h after a light breakfast | No | 450 | 12.5 | 1-May-15 | USA | 23 |
| F1-F3 | Sativex | Fasted | 24h fast pre-dose with no food 15 mins before and after morning dose | No | 0 | 0 | 4-Nov-03 | UK | 16 |
| F4 | Oral Capsule | Fasted | 24h fast pre-dose with no food 15 mins before and after morning dose | No | 0 | 0 | 4-Nov-03 | UK | 16 |
| G | Sativex | Fasted | Fasted conditions | No | 0 | 0 | 16-Jun-10 | UK | 4 |
| H1-H5 | Epidiolex | Fasted | Overnight fast of at least 10h | Yes | 0 | 0 | 30-Oct-18 | Netherlands | 10 |
| H6 | Epidiolex | Fed | Overnight fast of at least 10h, high-fat breakfast given 30 mins before dose | Yes | 918 | 62 | 30-Oct-18 | Netherlands | 10 |
| H7-H8 | Epidiolex | Fasted | Overnight fast before first dose, 2h fast before evening dose (6 days), single dose on 7th day | Yes | 0 | 0 | 30-Oct-18 | Netherlands | 10 |
| I1-I4 | Oral Capsule | Fed | Light low-fat breakfast 1–2h before dose, snack 4h after dose | No | 450 | 12.5 | 12-Sep-19 | USA | 24 |
| J1 - J2 | Oral Capsule | Fed | Standard meal 30 mins before dose, after overnight fast | Yes | 574 | 26.4 | 10-Nov-17 | Israel | 20 |
| J3 | Sativex | Fed | Standard meal 30 mins before dose, after overnight fast | Yes | 574 | 26.4 | 10-Nov-17 | Israel | 20 |
| K1-K3 | Sativex | Fasted | Fasted 10h overnight and 4h post dose | Yes | 0 | 0 | 22-Nov-12 | UK | 17 |
| K4-K6 | Sativex | Fasted | Fasted 10h overnight and 4h post dose | Yes | 0 | 0 | 22-Nov-12 | UK | 17 |
| L1-L4 | Epidiolex | Fed | Low-protein breakfast 2h before dose after an 8h overnight fast | No | 450 | 12.5 | 28-Mar-19 | Hungary, Czech Republic, Slovakia | 14 |
| M1 | Epidiolex | Fasted | Fasted overnight for 10h, meal given 4h after dose | Yes | 0 | 0 | 27-Jun-19 | USA | 15 |
| M2 | Epidiolex | Fed | Fasted overnight 10h, high-fat breakfast burrito given 30 mins before dose | Yes | 850 | 60 | 27-Jun-19 | USA | 15 |
| N | Sativex | Fed | 36h fast before dose, standard low-fat breakfast 30 mins before dosing and standard meals 4h and 10h post-dose + digestive biscuits | Yes | 450 | 12.5 | 15-Apr-05 | UK | 18 |
Data point nomenclature is as follows: assigned letter corresponds to the publication and numbers (if any) correspond to individual studies within the publication