This was a prospective, single-centre, open label, randomized, two-arm, parallel design study to evaluate the effect of four-weeks consumption of active study product on primary endpoint in healthy adults
Cannabidiol (CBD), a non-psychoactive component of Cannabis sativa L., has been purported to have a variety of beneficial physiological effects including but not limited to, pain relief, anti-anxiety, anti-seizure, anti-depressant, anti-oxidant, and anti-inflammatory. Despite the enthusiasm of the CBD industry for these claims, the empirical evidence supporting favourable physiological responses is inconsistent. These discrepancies may in part be explained by differences in CBD bioavailability when administered orally that in turn may be influenced by non-standardized CBD formulation, and/or the body size and composition of the recipient. The purpose of this study was to test the bioavailability of two doses of a novel CBD formation given twice per day for three consecutive days in healthy study subjects and explore their potential acute anti-inflammatory properties as assessed by highly sensitive immunologic assays. The rationale for conducting the study was to evaluate the pharmacokinetic (PK) profile of a novel formulation of CBD designed to improve bioavailability given at two dose levels twice per day for three consecutive days. Although previous studies conducted in healthy study subjects have documented the safety and PK profile for a single dose of the test product, multiple ascending dose studies have not yet been conducted. In addition to evaluating multiple ascending dose PK, the pharmacodynamic properties of the CBD were assessed using ex vivo lipopolysaccharides (LPS) stimulated whole blood assays and high sensitivity serum cytokine assays.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
26
Cannabidiol (CBD), a non-psychoactive component of Cannabis sativa L.
Altantia Clinical Trials
Chicago, Illinois, United States
Plasma CBD pharmacokinetics of twice daily intake of 2 different doses of CBD over three days
Difference in plasma CBD concentration (ng/ml) between groups as measured by total Area Under the Curve (tAUC) derived from plasma
Time frame: T-30 minutes, T 0 minutes, T30 minutes, T60 minutes, T240 minutes (4 Hours), T480 minutes (8 Hours), and T4320 minutes (72 Hours)
Evaluate the safety of twice daily intake of 2 different doses of CBD over three 3 days
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: T-30 minutes, T 0 minutes, T30 minutes, T60 minutes, T240 minutes (4 Hours), T480 minutes (8 Hours), and T4320 minutes (72 Hours)
Plasma CBD maximal concentration (Cmax, ng/ml)
Difference in plasma Cmax concentration between groups as measured by total Area Under the Curve (tAUC) derived from plasma
Time frame: T-30 minutes, T 0 minutes, T30 minutes, T60 minutes, T240 minutes (4 Hours), T480 minutes (8 Hours), and T4320 minutes (72 Hours)
Plasma CBD time to peak (Tmax, minutes)
Difference in plasma Tmax concentration between groups as measured by total Area Under the Curve (tAUC) derived from plasma
Time frame: T-30 minutes, T 0 minutes, T30 minutes, T60 minutes, T240 minutes (4 Hours), T480 minutes (8 Hours), and T4320 minutes (72 Hours)
Percentage Change between groups on whole blood LPS stimulated cytokines (% change)
Differences between groups for the change from baseline were assessed for whole blood LPS stimulated cytokines
Time frame: T0 minutes, T4320 minutes(72 Hours)
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