PERCEPTION AND TOLERABILITY OF NICOTINE FILMS FOR USE IN THE MOUTH. A RANDOMIZED, CROSSOVER, PHASE-II, STUDY IN HEALTHY SMOKERS.

Pfizer Health AB0 个研究点开始时间: 2004年12月10日最近更新: 2012年3月19日

适应症

试验速览

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•1. Healthy male and female subjects between the ages of 20 and 50 years, inclusive. Health is defined, as judged by the investigator, as the absence of clinically relevant abnormalities identified by a detailed medical history, physical examination including blood pressure and pulse rate measurements and 12-lead ECG.
•2. Smoking of at least 10 cigarettes daily during at least three years preceding inclusion and no intention to quit within three months from inclusion.
•3. For females: Postmenopausal state with absence of menstrual discharge for at least two years and a serum FSH level >30 IU/L or premenopausal/perimenopausal state with effective contraception (oral or implanted hormonal contraceptives, intrauterine device or status after operative sterilization).
•4. Ability to understand both oral and written Swedish.
•5. Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the trial.
•6. Willingness and ability to comply with the scheduled visit, treatment plan and other trial procedures specified in this protocol.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years)
•F.1.3.1 Number of subjects for this age range

•1.Evidence or history of a severe acute or chronic medical or psychiatric condition or all ergy or laboratory abnormality, or usage of drugs, that, in the judgment of the investigator, increase the risk associated with study participation or interfere with the interpretability of study results.
•2. Females: Pregnant, breast-feeding, premenopausal, or perimenopausal, state with insufficient contraception as specified under Inclusion Criteria.
•3. History of regular alcohol consumption in the 6 months before screening. Weekly limits are 2 L of wine or 5 L of beer or 0.6 L of spirits for females and 3 L of wine or 7.5 L of beer or 0.9 L of spirits for males. The investigator may lower these limits if a subject consumes different types of alcoholic beverages.
•4. Treatment with an investigational drug within 3 months preceding the first dose of trial medication.
•5. History or current complaints of dry mouth.
•6. Acute or chronic oral or lips disease, including cold sores, impairing chewing function or sensory functions of the oral mucosa.
•7. Upper respiratory infection.
•8. Work in any of the following areas: marketing, market research, advertising, public relations, pharmacy, pharmaceutical industry or journalism.

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