Table 2.
Median (range) pharmacokinetic parameters of Δ9-tetrahydrocannabinol (THC), 11-nor-9-carboxy-THC (THCCOOH), cannabidiol (CBD) and cannabinol (CBN), before and after 5 and 15 mg oral THC and low-dose (5.4 mg THC + 5 CBD) and high-dose (16.2 mg THC + 15 mg CBD) oromucosal Sativex in 14 healthy adult cannabis smokers. Participants with no positive results throughout collection in each dosing session were excluded from calculations.
Analyte | Dose | Na | Cinitialb | Cmaxc | Tmax, hd | Claste | Tlast, hf |
---|---|---|---|---|---|---|---|
THC, ng/mL | 5 mg oral THC | 6 | 3.7 (<LOQ-9.0) | 6.0 (0.8–12.7) | 0.6 (−0.5–1.0) | 1.2 (0.7–3.7) | 10.5 (0.25–10.5) |
15 mg oral THC | 8 | 0.8 (<LOQ-20.5) | 1.6 (0.7–20.5) | 0.3 (−0.5–4.5) | 0.9 (0.5–5.8) | 4.5 (1–10.5) | |
Low Sativex | 14 | 0.8 (<LOQ-12.8) | 1815 (266–11424) | 0.25 (0.25–1.0) | 17.3 (1.0–60.0) | 10.5 | |
High Sativex | 14 | <LOQ (<LOQ-10.1) | 7853 (1323–18216) | 0.25 | 34.5 (2.9–92.0) | 10.5 | |
| |||||||
THCCOOH, pg/mL | 5 mg oral THC | 9 | 32.9 (<LOQ-109) | 39.1 (7.7–191) | 7.5 (−0.5–10.5) | 34.0 (7.7–191) | 10.5 (7.5–10.5) |
15 mg oral THC | 11 | 15.9 (<LOQ-274) | 49.3 (8.0–311) | 7.5 (1.0–10.5) | 44.5 (8.0–311) | 10.5 (4.5–10.5) | |
Low Sativex | 11 | 25.6 (<LOQ-129) | 44.2 (8.8–226) | 4.5 (−0.5–10.5) | 12.6 (8.3–141) | 10.5 (7.5–10.5) | |
High Sativex | 12 | 11.9 (<LOQ-138) | 35.6 (8.5–184) | 7.5 (−0.5–10.5) | 25.2 (8.5–176) | 10.5 (0.25–10.5) | |
| |||||||
CBD, ng/mL | 5 mg oral THC | 0 | NA | NA | NA | NA | NA |
15 mg oral THC | 1 | <LOQ | 0.8 | 0.25 | 0.6 | 1.0 | |
Low Sativex | 14 | <LOQ | 1975 (196–12120) | 0.25 (0.25–4.5) | 22.6 (0.5–67.8) | 10.5 | |
High Sativex | 14 | <LOQ | 7129 (1552–18636) | 0.25 | 34.6 (0.8–131) | 10.5 | |
| |||||||
CBN, ng/mL | 5 mg oral THC | 0 | NA | NA | NA | NA | NA |
15 mg oral THC | 1 | 1.1 | 1.1 | −0.5 | 1.1 | −0.5 | |
Low Sativex | 14 | <LOQ (<LOQ-1.1) | 140 (9.5–560) | 0.25 (0.25–1.0) | 2.0 (1.1–3.5) | 7.5 (4.5–10.5) | |
High Sativex | 14 | <LOQ (<LOQ-1.3) | 414 (74–2232) | 0.25 | 2.4 (1.2–6.9) | 10.5 (7.5–10.5) |
number of participants with cannabinoid concentrations >limit of quantification (LOQ) before and/or after dosing, and included in calculation of Cinitial, Cmax, Tmax, Clast and TClast
Cinitial, concentrations 0.5h prior to dosing
Cmax, maximum concentration
Tmax, time of Cmax
Clast, last specimen concentration ≥LOQ (0.5 ng/mL for THC and CBD; 7.5 pg/mL for THCCOOH; 1 ng/mL for CBN)
TClast, time of Clast