ISRCTN80837297已完成未知
A randomised, controlled, open-label, crossover study to assess the nicotine pharmacokinetic profile of different eLiquid formulations delivered by an eCigarette in healthy adult subjects
British American Tobacco (United Kingdom)0 个研究点目标入组 32 人开始时间: 2020年11月3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
- 32
研究概览
简要总结
2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37386281/ (added 04/07/2023)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •To be confirmed at screening:
- •1. Healthy male or female subject, between 21 and 60 years of age, inclusive. Age verification will be performed by checking valid forms of government issued identification (e.g., passport, driving licence or validate UK card) during screening
- •2. Female subject of childbearing potential willing to use a highly effective method of contraception or 2 effective methods of contraception, if applicable (unless of non-childbearing potential or where abstaining from sexual intercourse is in line with the preferred and usual lifestyle of the subject) from the first dose until 1 month after the last dose of IP
- •3. Female subject of non-childbearing potential. For the purposes of this study, this is defined as the subject being amenorrhoeic for at least 12 consecutive months or at least 4 months post-surgical sterilisation (including bilateral fallopian tube ligation or bilateral oophorectomy with or without hysterectomy)
- •4. Female subject with a negative pregnancy test at Screening
- •5. Female subject of menopausal status confirmed by demonstrating at Screening that the serum level of the follicle stimulating hormone (FSH) falls within the respective pathology reference range. In the event a subject's menopausal status has been clearly established (for example, the subject indicates she has been amenorrhoeic for 10 years, confirmed by medical history, etc), but serum FSH levels are not consistent with a postmenopausal status, determination of the subject’s eligibility to be included in the study will be at the Investigator’s discretion following consultation with the Sponsor
- •6. Subject with a bodyweight exceeding 52kg (males) or 45kg (females) and a body mass index (BMI) of 18.5 - 32 kg/m2. BMI
- •7. No clinically significant history of previous allergy/sensitivity to Nicotine or any of the excipients contained within the IP(s)
- •8. No clinically significant abnormal test results for serum biochemistry, haematology and/or urine analyses within 30 days before the first dose administration of the IP
- •9. Subject with a negative urinary drugs of abuse (DOA) screen (including alcohol) test results, determined within 30 days before the first dose administration of the IP (N.B.: A positive alcohol test result may be repeated at the Investigator’s discretion)
- •10. Subject with negative human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg)) and hepatitis C virus antibody (HCV Ab) test results at Screening
- •11. No clinically significant abnormalities in 12-lead electrocardiogram (ECG) determined within 30 days before the planned first nicotine dosing occasion
- •12. No clinically significant abnormalities in vital signs (blood pressure, pulse rate, and oral temperature) determined within 30 days before the planned first nicotine dosing occasion
- •13. Subject with an acceptable lung functions test as determined by the PI or appropriately qualified designee
- •14. Subject must be available to complete the study (including all follow up telephone call)
- •15. Subject must satisfy an Investigator about his/her fitness to participate in the study
- •16. Subject must provide written informed consent to participate in the study and be willing to abide by the study restric
排除标准
- •To be confirmed at Screening:
- •1. Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements within 30 days or 5 half-lives (whichever is longer) prior to the first dose of IP, unless in the opinion of the Investigator and Sponsor's Responsible Physician the medication will not interfere with the study procedures or compromise subject safety
- •2. Evidence of renal, hepatic, central nervous system, respiratory, cardiovascular or metabolic dysfunction
- •3. A clinically significant history of drug or alcohol abuse [defined as the consumption of more than 21 units for male and 14 units for female subjects) of alcohol a week] within the past two years
- •4. Inability to communicate well with the Investigators (i.e., language problem, poor mental development or impaired cerebral function)
- •5. Participation in a New Chemical Entity (NCE) clinical study within the previous 3 months or a marketed drug clinical study within the 30 days before the first dose of IP. (Washout period between studies is defined as the period of time elapsed between the last dose of the previous study and the first dose of the next study)
- •6. Donation of 450 mL or more blood within the 3 months before the first dose of IP, or plasma in the 7 days prior to screening or platelets in the 6 weeks prior to screening
- •7. Subjects who, prior to enrolment, are planning to quit smoking/vaping before the end of the follow-up period. (All subjects will be informed that they are free to quit smoking/vaping and withdraw from the study at any time)
- •8. Female subjects who are pregnant or breastfeeding. This will be confirmed at Screening and Admission. Any female subject who becomes pregnant during this study will be withdrawn
- •9. Subjects who have an acute illness (e.g. upper respiratory tract infection, viral infection, etc.) requiring treatment within 30 days prior to screening/ongoing infection at the time of admission
- •10. Subjects who are self-reported non-inhalers (smokers/vapers who draw smoke/aerosol from the cigarette/eCigarette into the mouth and throat but who do not inhale). Subjects who are observed as non-inhalers at Admission by the clinic staff will be excluded
- •11. Subjects who have a positive urine drugs of abuse or alcohol screen (confirmed by repeat) at Screening or Admission
- •12. Subjects who have used prescription or over-the-counter (OTC) bronchodilator medication (e.g. inhaled or oral ß-adrenergic agonists) to treat a chronic condition within the 12 months prior to screening
- •13. Subjects who have received any medications or substances (other than tobacco) which are known to be strong inducers or inhibitors of cytochrome P450 (CYP) enzymes within 14 days or 5 half-lives of the drug (whichever is longer) prior to screening
- •14. Subjects who perform strenuous physical activity (exceeding the subject’s normal activity levels) within 7 days prior to Screening or Admission
- •15. Employees and immediate relatives of the tobacco industry or the clinical site
- •16. Subjects who have any clinically relevant abnormal findings on the physical examination, medical history, ECG, lung function tests (During the Screening period Day-30 to Day -2) or clinical laboratory panel, unless deeme
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