Comparison of the relative bioavailability of ß-caryophyllene from two different formulations - a randomized, double-blind cross-over study in healthy subjects - BTS1371/19

Vesifact AG0 个研究点目标入组 24 人开始时间: 2020年1月24日最近更新: 2024年8月19日

适应症

试验速览

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•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

发起方

Vesifact AG