ISRCTN17828518已完成未知
A single-dose, randomised, crossover study to assess the pharmacokinetics of oral nicotine products and a cigarette in healthy adults who smoke combustible cigarettes and use smokeless pouch products
British American Tobacco (United Kingdom)0 个研究点目标入组 35 人开始时间: 2020年4月2日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 35
研究概览
简要总结
2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34923602/ (added 20/12/2021)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Provision of signed and dated informed consent form (ICF)
- •2. Stated willingness to comply with all study procedures and availability for the duration of the study
- •3. Healthy adult male or female
- •4. If female, meets one of the following criteria:
- •4.1. Is of childbearing potential and agrees to use two of the accepted contraceptive regimens from at least 28 days prior to the first study product administration through to at least 30 days after the last dose of study product. An acceptable method of contraception includes one of the following:
- •4.2. Systemic contraceptives (combined birth control pills, injectable/implant/insertable hormonal birth control products, transdermal patch)
- •4.3. Intrauterine device (with or without hormones)
- •4.4. Barrier methods of contraception (male condom with spermicide, female condom, cervical cap, diaphragm, contraceptive sponge)
- •4.5. Male partner vasectomised at least 6 months prior to the first study product administration
- •4.6. Is of childbearing potential and agrees to abide by true abstinence from heterosexual intercourse, when this is in line with the preferred and usual lifestyle (not periodic abstinence)
- •4.7. Male partner has had a vasectomy less than 6 months prior to dosing, and agrees to use an additional acceptable contraceptive method from the first study product administration through to at least 30 days after the last dose of study product
- •4.8. Is of non-childbearing potential, defined as surgically sterile (i.e. has undergone complete hysterectomy, bilateral oophorectomy, or tubal ligation) or is in a postmenopausal state (i.e. at least 1 year without menses without an alternative medical condition prior to the first study product administration)
- •5. Aged at least 19 years but not older than 55 years
- •6. Body mass index (BMI) within 18.5 kg/m2 to 30.0 kg/m2, inclusively
- •7. Minimal body weight of 52 kg (males) or 45 kg (females)
- •8. Daily snus user and have used snus products for at least 6 months and who use snus products under their upper lip. Subjects who use pouched snus should regularly use pouch weights of 0.8 g and above, and at least 8 mg nicotine/pouch.
- •9. Subject must be able to use 3 or more 8 mg nicotine pouches in a 3 hour period without any discomfort
- •10. Smoker of 5 cigarettes or more on average per week and who has smoked for at least 1 year prior to the first study product administration
- •11. Stated willingness to abstain from nicotine and tobacco products (except for the study products provided) from 12 hours prior to each study product administration until the end of each PK sampling
- •12. Positive urine cotinine test (=50 ng/mL) at screening and prior to the first study product administration
- •13. Successful completion of the product familiarisation session for study product use prior to the first study product administration (subject is able to follow the instructions and does not experience AEs during the training session)
- •14. Clinical laboratory values within the laboratory's stated normal range; if not within this range, they must be without clinical significance, as determ
排除标准
- •1. Female who is lactating at screening
- •2. Female who is pregnant according to the pregnancy test at screening or prior to the first study product administration
- •3. Self-reported non-inhalers of cigarettes (smokers who draw the smoke from the cigarette into the mouth and throat but who do not inhale)
- •4. Presence of braces, partials, dentures or any dental work that could, in the opinion of an investigator, affect the conduct of the study (including missing molars)
- •5. Presence or history of significant form of oral and/or pharyngeal inflammation, oral lesions and/or gum disease or temporomandibular joint dysfunction
- •6. History of significant hypersensitivity to any excipients of the formulations as well as severe hypersensitivity reactions (like angioedema) to any drugs
- •7. Presence or history of significant gastrointestinal, liver or kidney disease, or surgery that may affect drug bioavailability
- •8. History of significant cardiovascular, pulmonary, hematologic, neurological, psychiatric, endocrine, immunologic or dermatologic disease
- •9. Presence of clinically significant ECG abnormalities at the screening visit, as defined by medical judgment
- •10. Maintenance therapy with any drug (with the exception of hormonal contraceptives or hormone replacement therapy) or significant history of drug dependency or alcohol abuse (> 3 units of alcohol per day, intake of excessive alcohol, acute or chronic)
- •11. Any clinically significant illness in the 28 days prior to the first study product administration
- •12. Use of any prescription drugs (with the exception of hormonal contraceptives or hormone replacement therapy) in the 28 days prior to the first study product administration, that in the opinion of an investigator would put into question the status of the participant as healthy
- •13. Use of any medication or substance that aids in smoking cessation, including but not limited to any nicotine replacement therapy (e.g., nicotine gum, lozenge, patch), varenicline (Chantix®), bupropion (Wellbutrin®, Zyban®), or Lobelia extract in the 28 days prior to the first study product administration
- •14. Any history of tuberculosis
- •15. Positive test result for alcohol and/or drugs of abuse at screening or prior to the first product administration
- •16. Positive screening results to Hepatitis B surface antigen (HbsAG), hepatitis C antibody or HIV
- •17. Previous inclusion in this clinical study
- •18. Intake of an Investigational Product (IP) in any other clinical trial in the 28 days prior to the first study product administration
- •19. Subjects who have donated:
- •19.1. =400 mL of blood within 90 days prior to admission
- •19.2. Plasma in the 7 days prior to admission
- •19.3. Platelets in the 6 weeks prior to administration
- •20. Postponement of a decision to quit using tobacco- or nicotine-containing products in order to participate in this study
- •21. Previously attempted to quit using tobacco- or nicotine-containing products in the 28 days prior to the first study product administration.
- •22. Employees or immediate relatives of the tobacco industry or the clinical site.
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