A Multi-center, Randomized, Controlled, Partially Blinded Study to Assess the Pharmacokinetics and Comparative Bioavailability of Nicotine From Two Variants of Nicotine Pouch 2.0 (NP2), 4mg and 6mg, Compared to Nicotine Lozenge 4mg and Nicotine Gum 4mg in Adult Cigarette Smokers

Philip Morris Products S.A.4 个研究点分布在 1 个国家目标入组 56 人开始时间: 2023年10月20日最近更新: 2024年8月13日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方: Philip Morris Products S.A.
入组人数: 56
试验地点: 4
主要终点: Time to the observed maximum concentration [Tmax]

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This is a multi-center, randomized, controlled, partially blinded study to assess the pharmacokinetics and comparative bioavailability of nicotine from two variants of NP2 (4 and 6 mg) in comparison with Loz-4mg and Gum-4mg in adult cigarette smokers. The subjects will be blinded to the randomized sequence and will be blinded to the variants of NP2 they will receive. The study will be conducted with 4 periods and 4 sequences in a Williams design (crossover).

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Crossover
主要目的: Basic Science
盲法: Double (Participant, Investigator)

盲法说明

This is a partially blinded study. The Investigator and subjects will be blinded to the randomized sequence and to the variants of the investigational product (IP). In contrast, the pharmacy staff will not be blinded to the randomized sequence and to the variants of the IP.

入排标准

年龄范围: 18 Years 至 55 Years（Adult）
性别: All
接受健康志愿者: 是

入选标准

•Subject has signed the ICF and is able to understand the information provided in the ICF.
•Subject has smoked on a daily basis for at least the last 18 months prior to the Screening visit.
•Subject has smoked on average ≥10 commercially available regular CIG/day over the last 4 weeks. Smoking status will be verified based on a urinary cotinine test (cotinine ≥200 ng/mL).
•Subject is healthy as judged by the Investigator based on available assessments from the screening period (e.g., safety laboratory, spirometry, vital signs, physical examination, ECG, and medical history).

排除标准

•Subject has reasons other than medical (e.g., psychological, social reason) not to be part of the study, as determined by the Investigator.
•Subject is legally incompetent, or physically or mentally incapable of giving consent (e.g., emergency situation, under guardianship, prisoners).
•Subject has a clinically relevant disease which requires medication or any other medical condition including abnormal spirometry, safety laboratory, as determined by the Investigator.
•Subject presents difficulty with venipuncture and/or poor venous access.
•Subject has an oromucosal or dental condition, which may affect the use of the investigational products, as determined by the Investigator or subject has orthodontic braces and retention wire (could likely interfere with the gum dosing).
•Subject has medical conditions which require, or will require during the study, a medical intervention (e.g., start of treatment, surgery, hospitalization).
•Presence of fever (body temperature >37.5°C) (e.g., a fever associated with a symptomatic viral or bacterial infection) within 2 weeks prior to dosing.
•Subject has a Hemoglobin level < 11.0 g/dL for females and < 12.0 g/dL for males at the Screening.
•Subject uses medication or any substance that aids in smoking cessation.
•Subject postponed the decision to quit using tobaccoor nicotine-containing products in order to participate in this study.
•Subject previously attempted to quit using tobacco- or nicotine-containing products within 28 days prior to the first study product administration.
•Subject has donated plasma within seven days prior to Screening or has donated or lost 450 mL or more of whole blood within 8 weeks prior to Screening for males, and in the 12 weeks prior to Screening for females.
•Subject has a known sensitivity or allergy to any of the investigational products, or ingredients.
•Subject has a positive serology test for HIV 1/2, Hepatitis B, Hepatitis C.
•Subject has a history of alcohol abuse within one year prior to screening or regular use of alcohol within six months prior to screening that exceeds 10 units for women or 15 units for men of alcohol per week (1 unit = 340 mL of beer 5%, 140 mL of wine 12%, or 45 mL of distilled alcohol 40%).
•Subject has a positive urine drug test. Investigator will assess whether THC positive subjects are eligible for participation in the study.
•Subject has a positive alcohol breath test.
•Subject or one of their family members is a current or former employee of the tobacco industry.
•Subject or one of their family members a is an employee of the investigational site or of any other parties involved in the study.
•Subject has participated in another clinical study within 30 days prior to the Screening Visit or concomitantly participates in an investigational study involving no drug or device administration.
•Subject has been previously screened or enrolled in this study (except alternate subjects).
•For women only: subject is pregnant (does not have negative pregnancy tests at Screening Visit and at Admission) or is a lactating female.
•For women of childbearing potential only: subject does not agree to use an acceptable method of effective contraception.