Determination of bioavailability of hemp extract of two different formulations in healthy subjects: randomized, double blind cross-over desig
- Conditions
- Healthy subjects (women and men)
- Registration Number
- DRKS00015283
- Lead Sponsor
- Vesifact AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 16
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
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
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.