Healthy subjects (women and men)
Conditions
Interventions
Group 1: Hemp extract, formulated as SEDDS (Self-emulsifying drug delivery system), equivalent to 25 mg cannabidiol
Single dose oral, 1 capsule
Group 2: Hemp extract without SEDDS, equivalent to 25 mg cannabidiol
Sponsors
Vesifact AG
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: - Subject is able and willing to sign the Informed Consent Form prior to screening evaluations - Sex: female and male (8 of each gender) - BMI =19 and =30 kg/m² - Nonsmoker - Subject is in good physical and mental health as established by medical history, physical examination, electrocardiogram, vital signs, results of biochemistry, haematology
Exclusion criteria
Exclusion criteria: Main exclusion criteria: - Relevant history or presence of any severe medical disorder, potentially interfering with this study (e.g. mal absorption, chronic gastro-intestinal diseases, heavy depression, diabetes, acute cancers within last 3 years except basal cell carcinoma of the skin, etc.) - A significant CVD event within last 3 months incl. myocardial infarction, stroke, congestive heart failure - Significant changes in lifestyle or medication (within last 3 months) or surgical intervention or surgical procedure such as bariatric surgery - Blood donation within 1 month prior to study start or during study - “Extreme dietary regimes”: vegan lifestyle, weight loss diet with <1200 kcal/day for women and <1800 kcal for men - Intake of anticoagulants like Heparin, Marcumar etc. - Known pregnancy, breast feeding or intention to become pregnant during the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison of AUC0-8h between the two formulations. The CBD content in the plasma samples is determined at 0 h, 0.5 h, 1 h, 2 h, 3 h, 4 h, 5 h, 6 h, 8 h and 24 h. The characteristics are determined from the concentration-time curves. | — |
Secondary
| Measure | Time frame |
|---|---|
| Comparison of the following pharmacokinetic endpoints between the two formulations: AUC0-24h, Cmax, Tmax. The characteristics are calculated from the plasma concentration-time curves, see above. | — |
Countries
Germany
Contacts
Public ContactTanita Dharsono
BioTeSys GmbH
Outcome results
None listed