Pharmacokinetics of a Single-Dose of
Liposomal AquazomeV² Oil in Humans
Principal Investigator: Gregory L. Smith, MD, MPH, Primary Investigator, Nex Therapeutics
A pharmacokinetics study of a single dose of liposomal AquazomeV² in humans was conducted in 2022. The subjects were given 0.3ml of AquazomeV² in pre-filled syringes.
The subjects had not used any cannabinoids for 7 days prior to the study, and they were fasting for 8 hours prior to the study. They had a baseline blood test for plasma CBD, time zero. Subsequent blood draws were done on all subjects at 15 minutes, 30 minutes, 45 minutes and 90 minutes for analysis of CBD serum levels.
The data from the studies reveal that all the subjects had measurable CBD levels at 15 minutes (average 5.057ng/ml), consistent with very early absorption of the CBD.
Comparative Pharmacokinetics
Cmax ng/ml Tmax hours Bioavailability
Oral CBD Extract 10mg 2.47 1.27 6.00 %
Oral CBD Extract 400mg 181.00 3.00 6.00 %
Oral Aquazome V² 0.3ml 34.48 0.5 – 1.5 79.90 %
The study showed AquazomeV² had 79.9% absorbability in 30 – 90 minutes, vs. hemp oil at 6% absorbability in 90 – 180 minutes. The study concludes that AquazomeV² is a very effective delivery platform for CBD.
The studies show relatively faster absorption and markedly improved bioavailability with AquazomeV², compared to other ingested oil delivery. The subjective effects found in the questionnaires were consistent with the early absorption seen on the serum levels. There were no reported adverse effects.
PK Study Questionnaire Results
Questionnaire:
After 24 hours, subjects reported:
Sleep: 100% reported they slept the same or better – 77% slept better; 44% slept much better.
Anxiety: 100% reported they felt the same or better – 66% had less anxiety, 44% reported much improvement, even no anxiety.
Pain: 100% reported they felt the same or better – of that group, 55% had less pain, 22% reported they had no more pain.
Energy: 88% reported they had the same energy or better – 55% had more; 11% had much more.
Cravings: 88% reported they had the same cravings or less – 66% had less cravings; 22% had no cravings.
Focus: 100% reported they had same or better focus – 33% had improved focus; 11% had much improved focus.
Testing Process Questionnaire:
Time until results felt: Average “Between 30 and 45 minutes”
Feeling from effects: Average “Relaxed”
Willing to repeat study: Average said “Definitely”