E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
to investigate smokers’ overall acceptability 20 minutes after administration of a pullulan-based nicotine film at doses of 2 and 3 mg and a metolose-based nicotine film of 2 mg. |
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E.2.2 | Secondary objectives of the trial |
to investigate smokers’ overall acceptability 0.5, 2 and 5 minutes after administration of the study products,
to investigate particular aspects of the acceptability of the study products,
to determine if any of the study products is more preferred than the others,
to assess urges to smoke at specified times during the study treatments,
to assess tolerability and safety of the study treatments.
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
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.
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E.4 | Principal exclusion criteria |
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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E.5 End points |
E.5.1 | Primary end point(s) |
The primary study endpoint is overall acceptability rated 20 minutes after dose. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
Perception and tolerability study |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | Yes |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |