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 each subject’s maximum plasma concentration of nicotine (Cmax) and (Tmax) of one single dose of 4 mg Nicachet nicotine oromucosal powder in pouch to that of one piece of 4 mg Nicorette® chewing gum and 1mg (two sprayings of 0.5 mg) Nicorette® nasal spray, respectively (hybrid application). |
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E.2.2 | Secondary objectives of the trial |
From the nicotine plasma concentration-time curves the plasma concentration of nicotine at 30 minutes after administration (C30min), AUC6h, AUCinf, and T1/2 will be calculated. Secondary objective is to compare these variables, for Nicachet 4mg nicotine oromucosal powder in pouch to the 4mg Nicorette® chewing gum and 1mg Nicorette® nasal spray.
To compare each subject’s rating of subjective effects using a Visual Analogue Scale (VAS) anchored with "not at all" to "extremely" at the time points of blood sampling.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Consent to participate voluntarily and sign Informed Consent prior to any study procedure. 2. Healthy male and female, age 18 through 50 years. 3. Willing and able to take oral medication. 4. Willing and able to comply with the study specific procedures. 5. Smoker of >7 cigarettes/day. |
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E.4 | Principal exclusion criteria |
1. Use of snuff. 2. Second or third degree AV block or sick sinus syndrome; congestive heart failure classified as functional Class III or IV by the New York Heart Association; myocardial infarction within six months of baseline; a prolonged QTc interval at screen or pretreatment (defined as a QTc interval of > 450 msec for male and females or > 470 msec for female and females); other clinically significant heart conditions which would negatively impact on the patient completing the study. 3. Subjects with clinically significant liver disease which may prevent the patient from completing the study and/or an elevation in total bilirubin, alkaline phosphatase, LDH, ASAT, or ALAT of > 3 times the upper limit of the laboratory reference interval. 4. Subjects with clinically significant renal disease which may prevent the patient from completing the study and/or an elevation in serum creatinine of > 1.5 times the laboratory reference. 5. Surgery within 6 months of the Baseline visit that, in the opinion of the investigator, could negatively impact on the patient’s participation in the clinical study. 6. Subjects who are participating in other drug studies or who have received other investigational drugs within 30 days prior to enrolment. Additionally, subjects previously included into this study and whom then dropped out of the study is not to be re-entered into the study. 7. Subjects with any surgical or medical condition, which, in the judgment of the clinical investigator, might interfere with the absorption, distribution, metabolism or excretion of the drug. 8. Subjects who are using drugs capable of inducing hepatic enzyme metabolism (e.g., barbiturates, rifampin, carbamazepine, phenytoin, primidone) within the previous 30 days (or 5 half lives of inducing agent, whichever is longer) of enrolment in this study. 9. Subjects with a medical history of seizures. |
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E.5 End points |
E.5.1 | Primary end point(s) |
To compare each subject’s maximum plasma concentration of nicotine (Cmax) and (Tmax) of one single dose of 4 mg Nicachet nicotine oromucosal powder in pouch to that of one piece of 4 mg Nicorette® chewing gum and 1mg (two sprayings of 0.5 mg) Nicorette® nasal spray. |
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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 | Yes |
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
| 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 | 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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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 | 1 |
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 |