PHARMACOKINETICS OF NICOTINE FILM FOR USE IN THE MOUTH. A RANDOMIZED, CROSSOVER, PHASE-I, COMPARATIVE STUDY IN HEALTHY SMOKERS.

Pfizer Health AB0 个研究点开始时间: 2004年11月11日最近更新: 2012年3月19日

适应症

试验速览

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•Healthy male and female subjects between the ages of 18 and 50 years, inclusive. Health is defined as the absence of clinically relevant abnormalities identified by a detailed medical history, physical examination, including blood pressure and pulse rate measurements, 12-lead ECG and clinical laboratory tests, as judged by the investigator.
•Smoking of at least 15 cigarettes daily during at least one year preceding inclusion and no intention to quit within three months from inclusion.
•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).
•Body Mass Index (BMI) of 17.5 to 30.0 kg/m2; and a total body weight 50.0 kg.
•Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the trial.
•Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, 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) no
•F.1.3.1 Number of subjects for this age range

•Evidence or history of a severe acute or chronic medical or psychiatric condition or allergy or laboratory abnormality, or use of drugs, that, in the judgment of the investigator, increase the risk associated with study participation or interfere with the interpretability of study results.
•Females: Premenopausal, or perimenopausal, state with insufficient contraception as specified under Inclusion Criteria.
•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.
•Treatment with an investigational drug within 3 months preceding the first dose of trial medication.
•Donation or loss of blood within 3 months prior to dosing, if the estimated lost blood volume equaled or exceeded 450 mL.
•History of sensitivity to heparin or heparin-induced thrombocytopenia.
•A pathological dental status interfering with normal chewing function.

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