Healthy men and women
Conditions
Interventions
Group 1: Beta-caryophyllene distilled from clove oil, formulated as SEDDS (Self-emulsifying drug delivery system), 100 mg beta-caryophyllene, single oral dose, 1 capsule
Group 2: Beta-caryophyllene di
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 (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
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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison of the pharmacokinetic parameter AUC0-12h between the two formulations. 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
| Measure | Time frame |
|---|---|
| Comparison of the pharmacokinetic parameters AUC0-24h, Cmax and Tmax between the two formulations. 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. | — |
Countries
Germany
Contacts
Public ContactYvonne Mödinger
BioTeSys GmbH
Outcome results
None listed