ISRCTN34837836进行中（未招募）Unknown
An open-label, randomized, controlled, crossover study to characterize nicotine pharmacokinetics of the JUUL2 Electronic Nicotine Delivery System (ENDS) in two flavors as compared to a commercially available ENDS product and the subjects’ usual brand of combustible cigarette
适应症
试验速览
- 阶段
- Unknown
- 状态
- 进行中（未招募）
- 入组人数
- 28
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.Provides voluntary consent to participate in this study documented on the signed ICF(s).
- •2.Adult, male or female smoker, 22 to 65 years of age, inclusive, at the Screening visit.
- •3.Has been a smoker =12 months prior to Screening.
- •4.Currently smokes an average of =10 manufactured combustible CPD, as self-reported at Screening.
- •5.Has past 30-day history of some day or every day ENDS use.
- •6.Has a positive urine cotinine (=200 ng/mL) at the Screening visit and Check-in.
- •7.Has an eCO =10 ppm at the Screening visit and Check-in.
- •8.Completes the screening process within 28 days prior to study Day -1.
- •9.Is willing to comply with the requirements of the study, including a willingness to use the study products during the study and to stop smoking during the required abstention periods in the study.
- •10.A female subject of childbearing potential must have been using one of the following forms of contraception, and agree to continue using it through completion of the study:
- •10.1.hormonal (e.g., oral, vaginal ring, transdermal patch, implant, or injection) consistently for at least 3 months prior to study Day 1;
- •10.2.double-barrier method (e.g., condom with spermicide, diaphragm with spermicide) from Day 1;
- •10.3.intrauterine device for at least 3 months prior to study Day 1;
- •10.4.abstinence beginning at least 6 months prior to Day 1;
- •10.5.a partner who has been vasectomized for at least 6 months prior to Day 1.
- •11.A female subject of non-childbearing potential must be postmenopausal with amenorrhea for at least 1 year prior to study Day 1 and FSH levels consistent with postmenopausal status or have undergone one of the following sterilization procedures at least 6 months prior to study Day 1:
- •11.1.hysteroscopic sterilization;
- •11.2.bilateral tubal ligation, occlusion, or bilateral salpingectomy;
- •11.3.hysterectomy;
- •11.4.bilateral oophorectomy.
排除标准
- •1.Has a history or presence of clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, laryngeal, oncologic, urologic, pulmonary (asthma, chronic obstructive pulmonary disease), immunologic, psychiatric, cardiovascular disease (hypertension, heart failure, chronic coronary syndrome, post-myocardial infarction status), diabetes mellitus, or any other condition that, in the opinion of the Investigator, would jeopardize the safety of the subject or impact the validity of the study results.
- •2.Has a clinically significant abnormal finding on the physical examination, medical history, vital signs, ECG, in the opinion of an Investigator and any abnormal findings in clinical laboratory results at the Screening visit.
- •3.Has had an acute illness (e.g., upper respiratory infection, viral infection) requiring treatment within 28 days prior to study Day 1.
- •4.Has a positive test result for COVID-19.
- •5.Has a positive test result to HIV Ag/Ab combo, HBsAg or HCVAb.
- •6.Has a fever (>100.4°F [38°C]) at Screening visit or at Check-in.
- •7.Has a positive urine test result for alcohol or drugs of abuse, or positive alcohol breath test at the Screening visit or at Check-in. If a positive urine drug test is observed, and it is believed that the positive urine test is due to prescription drugs, the PI should obtain documentation that;
- •a. confirms the subject’s use of the prescribed medication, and b. the prescribed medication will cause a false positive drug test.
- •8.Has an SBP <90 mmHg or >150 mmHg, DBP <40 mmHg or >95 mmHg, or HR <40 beats per minute (bpm) or >99 bpm at Screening.
- •9.Has experienced an allergic reaction following previous e-cigarette use or with exposure to any primary components of the e-liquids (nicotine, flavour, benzoic acid, propylene glycol and glycerol).
- •10.Has participated in a previous clinical study for an investigational drug, device, biologic, or tobacco product within 30 days prior to Screening.
- •11.Has donated blood or blood products >500 mL, had significant blood loss, or received whole blood or a blood product transfusion within 3 months prior to Screening.
- •12.If female, the subject is pregnant, has a positive pregnancy test at the Screening visit or at Check-in, is lactating, breast feeding, or intends to become pregnant during the time period from Screening through EOS.
- •13.Has used medications known to interact with cytochrome P450 (CYP) 2A6 (including, but not limited to, amiodarone, amlodipine, amobarbital, buprenorphine, clofibrate, clotrimazole, desipramine, disulfiram, entacapone, fenofibrate, isoniazid, ketoconazole, letrozole, methimazole, methoxsalen, metyrapone, miconazole, modafinil, orphenadrine, pentobarbital, phenobarbital, pilocarpine, primidone, propoxyphene, quinidine,
- •rifampicin, rifampin, secobarbital, selegiline, sulconazole, tioconazole, tranylcypromine) within 14 days or 5 half-lives of the drug, whichever is longer, prior to study Day 1.
- •14.Has used medications reported to interact with nicotine, including theophylline, ropinirole, and clozapine, within 14 days or 5 half-lives of the drug, whichever is longer, prior to study Day 1.
- •15.Has used any prescription smoking cessation treatments, including, but not limited to, varenicline (Chantix®) or bupropion (Zyban®) within 30 days prior to study Day 1.
- •16.Requires concomitant treatment with prescription or non-prescription products that contain pseudoephedrine (e.g., nasal/sinus decongestants).
- •17.Negative
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