kinetiek not applicable (study population consists of healthy research subjects)
Conditions
Interventions
In a random order research subjects receive a single dose of hemp extract
containing 70 mg CBD in soft gel capsules in a fasting state and with a
high-fat meal.
Sponsors
Wageningen Universiteit
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: - - BMI between 18,5 and 25 kg/m2 - Age between 18 and 60 years - Weight above 50 kg - Good general health (based on general health questionnaire) - Veins suitable for blood sampling - Able to speak Dutch - Pertinent willingness to abstain from using any hemp product (including recreational Cannabis) 2 weeks prior and the entire study period. - (If applicable) In case of using contraceptives, not willing to delay the break between two packets of the conception pill during which a woman gets her period during the study period.
Exclusion criteria
Exclusion criteria: - Is currently suffering from a disease - Has had a psychosis or a family history of psychosis - Has had any gastrointestinal condition/disease within the 3 months prior to the intervention - Haemoglobin (Hb) level 2 kg in the month prior to the intervention - Use of herbal dietary supplements (excluding vitamins and minerals) or grapefruit products, 2 weeks before the first testday and in between the testdays. - Allergic to products that are provided as part of the standardised diet - Following a specific diet (e.g. vegetarian, gluten free) - (History of) drug abuse, in this case meaning >1 x per month use of recreational drugs - Cannabis use in the 14 days preceding the first test day. - Smoking - Alcohol consumption of >10 standardised glasses per week. - Recent or planned blood donation (
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The plasma-time curve of CBD (quantitively) and 2 of its metabolites (semi-quantitatively) after intake of the Becanex natural hemp extract. These data will be evaluated studied applying descriptive pharmacokinetic analysis (maximum peak height (Cmax), time-to-peak (Tmax), Half-life (T1/2) and area-under-the-curve (AUC)). Relative bioavailability in the fed versus fasted state will be determined by dividing individual AUC values. | — |
Secondary
| Measure | Time frame |
|---|---|
| The differences in CBD kinetics will be determined between men and women | — |
Countries
Netherlands
Outcome results
None listed