ISRCTN69161830进行中（未招募）Unknown
A randomised, controlled, single-centre, open-label study to assess the pharmacokinetics of cannabidiol in tincture, shot and chew products in healthy adult subjects
British American Tobacco (United Kingdom)0 个研究点目标入组 36 人开始时间: 2023年9月7日最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 36
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Subjects will be:
- •1.1. Males or females.
- •1.2. 19 to 55 years of age, inclusive, demonstrated by appropriate proof of identification.
- •1.3. Non-smoker and non-nicotine user who has not smoked or used tobacco/nicotine-containing products e.g. e-cigarettes, heated tobacco products, nicotine pouches or nicotine replacement therapy in the last month.
- •2. Subjects will have a:
- •2.1. Body mass index (BMI) of 18.5 to 32.0 kg/m², inclusive.
- •2.2. Body weight exceeding 52.0 kg (males) or 45.0 kg (females).
- •3. Subjects will be in good health, as judged by the PI or an appropriately qualified designee based on:
- •3.1. Medical history
- •3.2. Physical examination
- •3.3. Vital signs assessment
- •3.4. 12-lead ECG
- •3.5. clinical laboratory evaluations
- •4. Subjects will have given their written informed consent to participate in the study and will have agreed to abide by the study restrictions.
- •5. Subjects must demonstrate the ability to comprehend the informed consent form (ICF), be able to communicate well with the PI or an appropriately qualified designee, understand and comply with the requirements of the study, and be judged suitable for the study in the opinion of the PI or an appropriately qualified designee.
- •6. Subjects will have a urinary cotinine level <200 ng/ml.
- •7. Subjects will be willing to refrain from consuming alcohol within 24 hours prior to admission.
- •8. Subjects must be willing to use the study products and use only the products provided to them during clinical confinement, and to abstain from any other CBD product use when instructed.
- •9. Female subjects must be of non-childbearing potential or must use appropriate contraceptive methods.
排除标准
- •Subjects will be excluded from the study if they meet any of the following criteria at screening and admission, unless otherwise stated:
- •1. Male subjects who do not agree, or whose partners of childbearing potential do not agree, to use a barrier method of contraception (i.e., a condom) in addition to another highly effective method of contraception used by their female partners or to refrain from donating sperm from admission until the end of the study.
- •2. Female subjects who are pregnant or breastfeeding. This will be confirmed at Screening and admission.
- •3. Subjects who have donated:
- •3.1. =400 ml of blood within 90 days prior to admission.
- •3.2. Plasma within 90 days prior to admission.
- •3.3. Platelets within 6 weeks prior to admission.
- •3.4. Bone marrow within the last 6 months prior to admission.
- •4. Subjects who have an acute illness (e.g., upper respiratory tract infection, viral infection, etc.) requiring treatment within 4 weeks prior to admission.
- •5. Subjects who smoke or use other types of tobacco/nicotine-containing products in the month prior to screening, as reported at screening.
- •6. Subjects who self-report they are not able or are unwilling to abstain from caffeine for the duration of confinement without withdrawal symptoms.
- •7. Presence of braces, partials, dentures, or any dental work that could, in the opinion of the PI, affect the conduct of the study.
- •8. Presence or history in the last 6 months of a significant form of oral and/or pharyngeal inflammation, oral lesions and/or gum disease or temporomandibular joint dysfunction.
- •9. Subjects who are unable to chew study products.
- •10. Subjects who:
- •10.1. Have a significant history of alcoholism or drug/chemical abuse within 24 months prior to screening, as determined by the PI or an appropriately qualified designee.
- •10.2. Drink alcohol in excess of 21 units per week for males or 14 units per week for females, with one unit = 150 ml of wine or 360 ml of beer or 45 ml of 45% alcohol
- •11. Subjects who have a positive urine drugs of abuse or alcohol screen (confirmed by repeat) at screening or admission. Subjects with a positive result for cannabinoids will not be excluded.
- •12. Subjects who have consumed grapefruit, grapefruit juice, Seville oranges, marmalade, pomelo containing products, within 14 days prior to admission and then throughout the entire study duration.
- •13. Subjects who:
- •13.1. Are carriers of the hepatitis B surface antigen (HBsAg)
- •13.2. Are carriers of the hepatitis C antibody
- •13.3. Have a positive result for the test for human immunodeficiency virus (HIV) antibodies.
- •14. Subjects who have received any medications or substances (except for CBD) which are known to be strong inducers or moderate or strong inhibitors of CYP3A4 or CYP2C19 enzymes and/or P gp within 28 days (for inducers, including St. John’s Wort) or 14 days (for inhibitors) prior to admission and throughout the study.
- •15. Subjects who perform strenuous physical activity (exceeding the subject’s normal activity levels) within 7 days prior to screening or admission and who are not willing to abstain from strenuous physical activity while in-house.
- •16. Subjects who have been on a diet incompatible with the on study diet, in the opinion of the PI or an appropriately qualified designee, within the 30 days prior to start of and throughout the study
- •17. Subjects who are unable to communicate effectively with the PI/study staff (i.e., language problem, poor mental development, or impaired cerebral function).
研究者
相似试验
进行中（未招募）
不适用
A study to assess the pharmacokinetic of cannabidiol (CBD) following use of vapour, oral pouch, edible and chew CBD ProductsISRCTN12046333British American Tobacco (United Kingdom)36
进行中（未招募）
Unknown
A study to assess in-the-moment product liking of a heating device with two variants of an alternative non-tobacco, nicotine-containing consumable in healthy adult heated tobacco product usersISRCTN13625876British American Tobacco (United Kingdom)36
进行中（未招募）
不适用
A single-center, open-label, controlled, randomized study to investigate the impact of a sequential oral contraceptive containing estradiol valerate and dienogest (SH T00658ID) as compared to a sequential oral contraceptive containing ethinylestradiol and levonorgestrel (SH D00264A) on plasma lipids, hemostatic variables, and carbohydrate metabolism in 60 healthy female volunteers aged 18-50 years over 7 treatment cycles - Metabolism study vs Triquilar 21+7ContraceptionEUCTR2004-001614-13-DESchering AG60
已完成
4 期
A single-centre, open-label, randomized controlled trial of efficacy, safety and usability of a basal insulin algorithm incorporated into the GlucoTab system compared to standard care for glycaemic management in geriatric patients with type 2 diabetes at acute geriatric care wardstype 2 diabetesE11Type 2 diabetes mellitusDRKS00012553Medizinische Universität GrazKlinische Abteilung für Endokrinologie und Diabetologie58
进行中（未招募）
1 期
Investigation of efficacy, safety and usability of the GlucoTab system with an integrated long-acting insulin scheme for type 2 diabetes in the geriatric care settingDiabetes mellitus type 2MedDRA version: 19.1 Level: PT Classification code 10067585 Term: Type 2 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disordersEUCTR2017-000955-25-ATMedical University of Graz80