Comparison of the relative bioavailability of ß-caryophyllene from two different formulations - a randomized, double-blind cross-over study in healthy subjects
- Conditions
- Healthy men and women
- Registration Number
- DRKS00020461
- Lead Sponsor
- Vesifact AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 24
• Subject is able and willing to sign the Informed Consent Form prior to screening evaluations
• Sex: female and male (12 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 and haematology
• Subject is willing to comply with dietary restrictions 2 days prior to kinetic days
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 mo. incl. myocardial infarction, stoke, congestive heart failure
• Significant changes in lifestyle or medication (within last 3 mo.) or surgical intervention or surgical procedure such as bariatric surgery
• Application of corticoids and other immunesuppressing drug (within last 2 weeks)
• 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.
• Regular use of drugs or dietary supplements that may influence this study (within the last 2 weeks before study start or during the study), such as hemp / cannabis products, clove oil, herbal extracts, 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 the pharmacokinetic parameter AUC0-12h between the two formulations.<br>The BCP content in plasma samples will be determined at the following time points: 0h, 0.5h, 0.75h, 1h, 1.25h, 1.5h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h and 24h. The respective pharmacokinetic parameters are determined from the obtained concentration-time curves.
- Secondary Outcome Measures
Name Time Method Comparison of the pharmacokinetic parameters AUC0-24h, Cmax and Tmax between the two formulations.<br>The BCP content in plasma samples will be determined at the following time points: 0h, 0.5h, 0.75h, 1h, 1.25h, 1.5h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h and 24h. The respective pharmacokinetic parameters are determined from the obtained concentration-time curves.