EUCTR2010-023268-42-SE进行中（未招募）不适用
ICOTINE PHARMACODYNAMICS WITH A NEW ORAL NICOTINE REPLACEMENT PRODUCT AND NICOTINE GUM 4 MG. A STUDY IN HEALTHY SMOKERS.
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- McNeil AB
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Healthy male or female subjects between the ages of 19 and 55 years, inclusive. Health is defined as the absence of clinically relevant abnormalities as identified by a detailed medical history, a physical examination, blood pressure, pulse rate and hemoglobin measurements, as judged by the investigator or an authorized physician. The responsible physician may request additional investigations or analyses if necessary.
- •2.Smoking of more than 20 cigarettes daily during at least one year preceding inclusion.
- •3.For females: Postmenopausal state (absence of menstrual discharge for at least two years and a serum FSH level exceeding 30 IU/L) or premenopausal/perimenopausal state with an effective means of contraception (oral, injected or implanted hormonal contraceptives, intrauterine device, or status after operative sterilization), or declared absence of sexual contact during the study. Males: No pregnant spouse or partner at screening and willingness to protect their spouse or sexual partners from becoming pregnant during the study.
- •4.Body Mass Index (BMI) between 17.5 and 32.0 kg/m2 and a total body weight at a minimum 55.0 kg.
- •5.A personally signed and dated informed consent document, indicating that the subject has been informed of all pertinent aspects of the study.
- •6.Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures specified in the 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
排除标准
- •1.Evidence or history of an acute or chronic medical or psychiatric condition or allergy or laboratory abnormality, or of use of drugs that, in the judgment of the investigator or an authorized study physician, increases the risk associated with study participation or interfere with the interpretability of study results.
- •2.Females: Pregnancy, breast-feeding, premenopausal, or perimenopausal, state with insufficient contraception as specified under Inclusion Criteria. Males with a pregnant spouse or partner or males who are not willing to prevent conception in a spouse or sexual partner.
- •3.History of regular alcohol consumption in the 6 months before screening, exceeding weekly limits of 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 product, other than those provided in this study between one month preceding the first treatment visit and the last treatment visit of the study.
- •5.Pathological oral status interfering with normal muscular, sensory, or absorptive function of the oral cavity.
- •6.Relationship to persons involved directly with the conduct of the study (i.e., principal investigator, subinvestigators, study coordinators, other study personnel, employees or contractors of the sponsor or Johnson & Johnson subsidiaries, and the family of each).
研究者
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