A Four-Part Study to Determine the Safety, Tolerability and Pharmacokinetics of the Oxette (Registered Trademark) Nicotine Inhaler, Including a Comparison with the Nicorette (Registered Trademark) Inhaler

Kind Consumer Limited0 个研究点目标入组 60 人开始时间: 2012年1月18日最近更新: 2020年1月13日

研究概览

暂无简介。

•1. Smoking male or female with a minimum age of at least 18 years and maximum age of 55 years.
•2.Smoke greater than or equal to 10 manufactured cigarettes per day for the last year.
•3. Smoke within 1 hour of waking.
•4. Expired carbon monoxide greater than 10ppm at screening.
•5. Body weight of at least 50 kg with a BMI range of 18.5 – 32.
•6. Availability of participant for the entire study period and willingness to adhere to protocol requirements, as evidenced by a signed, Informed Consent Form.
•7. Normal findings in the physical examination, vital signs and a 12 lead ECG.
•8. Women must be using one effective barrier method of contraception, be postmenopausal for at least 12 months prior to trial entry, or surgically sterile. Women of child-bearing potential must complete a serum pregnancy test prior to the first administration with a negative result.

•1. Known or suspected history of hypersensitivity to nicotine.
•2. History of confirmed chronic and/or serious pulmonary disease, including asthma or COPD.
•3. History of a heart attack or stroke.
•4. Females who are pregnant or breastfeeding.
•5. Participants with any co-morbidity, which in the opinion of the Principal Investigator, might place them at undue risk or which could interfere with the interpretation of study data.
•6. Presence or history of clinically significant cardiac or renal conditions.
•7. Participants taking prescription anticoagulant or anti-platelet medication.
•8. Participating in a clinical trial with an investigational drug within 30 days preceding this trial.
•9. Blood donation within 45 days preceding this trial.
•10.Participants who are known to have serum hepatitis or who are carriers of the hepatitis B surface antigen (HBsAg) or hepatitis C antibody or have a positive result to the test for Human Immunodeficiency Virus (HIV).
•11. Participants who had a clinically significant positive drug screen result at either the screening visit or on admission. (A drug screen may only be repeated where methodological reasons are believed to have led to a false positive result).

发起方

Kind Consumer Limited