ISRCTN65708311已完成未知
Single dose, randomized, crossover study to assess the pharmacokinetics of three oral nicotine products in healthy adult smokers under fasting conditions
British American Tobacco (United Kingdom)0 个研究点目标入组 34 人开始时间: 2020年3月18日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 34
研究概览
简要总结
2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35484309/ (added 29/04/2022)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Current inclusion criteria as of 20/07/2020:
- •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:
- •-Systemic contraceptives (combined birth control pills, injectable/implant/insertable hormonal birth control products, transdermal patch)
- •-intrauterine device (with or without hormones)
- •-Barrier methods of contraception (male condom with spermicide, female condom, cervical cap, diaphragm, contraceptive sponge)
- •-Male partner vasectomized at least 6 months prior to the first study product administration
- •4.2. 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)
- •4.3. 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
- •4.4. 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 50 kg
- •8. Primary tobacco product used in the last 6 months is combustible cigarettes or roll-your-own cigarettes
- •9. A smoker of 10 cigarettes or more >6 mg ISO tar per day who has smoked for at least 6 months prior to the first study product administration
- •10. Stated willingness to abstain from nicotine and tobacco products (except for the study products provided) from 24 hours prior to the first study product administration until the end of the study
- •11. Positive urine cotinine test (=200 ng/mL) at screening and prior to the first study product administration
- •12. Successful completion of the training session for study product use prior to the first study product administration (subject is able to follow the instructions and does not experience adverse events during the training session)
- •13. Clinical laboratory values within the laboratory's stated normal range; if not within this range, they must be without clinical significance, as determined by an investigator
- •14. Have no clinically significant diseases captured in the medical history or evidence of clinically significant findings on the physical examination (including oral mucosa examination and vital
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. Presence of any tongue piercings or history of any tongue piercings in the last 90 days prior to the first study product administration
- •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 pseudoephedrine in the 7 days prior to the first study product administration
- •14. 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
- •15. Any history of tuberculosis
- •16. Positive test result for alcohol and/or drugs of abuse at screening or prior to the first product administration
- •17. Positive screening results to HIV Ag/Ab Combo, Hepatitis B surface Antigen (HBsAG (B) (hepatitis B)) or Hepatitis C Virus (HCV (C)) tests
- •18. Inclusion in a previous group for this clinical study
- •19. Intake of an Investigational Product (IP) in any other clinical trial in the 28 days prior to the first study product administration
- •20. Donation of 50 mL or more of blood in the 28 days prior to the first study product administration
- •21. Donation of 500 mL or more of blood (Canadian Blood Services, Hema-Quebec, clinical studies, etc.) in the 56 days prior to the first study product administration
- •22. Postponement of a decision to quit using tobacco- or nicotine-containing products in order to participate in this study
- •23. Previously attempted to quit using tobacco- or nicotin
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