A Randomized, Double-Blind, Placebo-Controlled Pharmacokinetic Study of the Chrono Nicotine Replacement Therapy System for adult male smokers

Chrono Therapeutics Australia Pty LTD0 个研究点目标入组 24 人开始时间: 2015年11月26日最近更新: 2020年1月13日

试验速览

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•1. Caucasian males, aged 18–50 years, inclusive.
•2. Smokers consuming on average between 20 and 40 cigarettes per day
•3. Body mass index (BMI) between 18.50 and 29.99 kg/m2.
•4. Ability to understand study procedures and provide written informed consent.

•1. Subjects with screening clinical laboratory tests, physical examination (PE), or electrocardiogram (ECG) outside normal range
•2. Subjects who have known or suspected infection with tuberculosis (TB), human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV).
•3. Subjects with positive screening urine test for non-prescription drugs, including opiates, amphetamines, barbiturates, benzodiazepines, methadone, cocaine and its metabolites, or cannabinoids.
•4. Subjects who are mentally or legally incapacitated, or have a history of psychiatric disorder.
•5. Subjects with severe hepatic, renal, cardiovascular, endocrine, or hematologic diseases, or with a history or illness
•6. Subjects with any sign of infection, with dermatologic diseases, or any condition that would inhibit transdermal absorption.
•7. Subjects who consume more than two alcoholic beverages per day on average
•8. Subjects who require any medications that may interfere with the absorption, metabolism, or excretion of the study drug.
•9. Subjects that have tattoos that could interfere with skin assessments.

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