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 compare single-dose treatments with NMG 6 mg and Nicorette Freshfruit gum 4 mg with respect to urges to smoke during the first 1 and 3 hours, respectively, after onset of chewing. |
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E.2.2 | Secondary objectives of the trial |
•to conduct between-treatment comparisons of urges to smoke during time intervals beginning at start of chewing and ending 3, 5 and 10 minutes, and 2, 4 and 5 hours, respectively, thereafter, •to compare the study treatments with respect to subjects’ acceptance of the products as a means of NRT, •to compare the amount of nicotine released from the gums during treatments, •to evaluate the tolerability of the study treatments.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
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.
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E.4 | Principal exclusion criteria |
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).
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary study endpoints are the area under the urges-to-smoke-vs.-time curve (AUC) from the start of nicotine administration until 1 hour and 3 hours thereafter (AUC1h, and AUC3h). |
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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 | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
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 | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
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) | Yes |
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
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
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 | No |
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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End of study is defined as the last visit of hte last subject. |
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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 | 0 |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |