Smoking
Conditions
Keywords
nicotine absorption, nicotine containing product, adult smoker, Nicorette, nicotine delivery system
Brief summary
The purpose of this study is to evaluate the pharmacokinetics (PK) and pharmacodynamics (PD, i.e., subjective effects) profiles, and the safety and tolerability of the nicotine-containing aerosol delivered by Platform 3 Liquid (P3L) system at three different nicotine levels in smoking healthy subjects in relation to Nicorette® inhalator.
Detailed description
The entire study will last between 16 to 49 days per subject. This includes : * a screening period of up to 4 weeks prior to admission, * 1 day of admission (Visit 2): after all inclusion/exclusion criteria are checked, all eligible subjects will be enrolled and perform a product test, first with P3L (at nicotine dose levels of approximately 50 μg/puff) and subsequently with Nicorette® inhalator (3 to 5 inhalations for each product). * 4 days of on-site product use (one day with Nicorette® inhalator \[Visit 3\] and three days with P3L \[Visit 4, Visit 5 and Visit 6\]), * 1 to 3 days between each product use and * a 7-day safety follow-up period (discharge + 7 days), during which there are no scheduled investigational visits, and during which adverse events (AEs) and serious adverse events (SAEs) can be spontaneously reported by the subjects and the follow-up of AEs/SAEs will be conducted by the study investigational site. Subjects will come to the investigational site the night before each assessment day, at least 12 hours prior to the product use, on Visit 4, Visit 5, and Visit 6. Subjects will stay overnight at the investigational site between the admission visit (Visit 2) and Visit 3. Smoking or use of any tobacco/nicotine-containing products or electronic cigarettes, apart from product use assigned on the assessment days, will not be allowed during their stay at the investigational site. Smoking will be allowed once the subjects have left the investigational site. The maximum concentration of nicotine (Cmax) and the area under the concentration-time curve from start of product use to the last quantifiable time point (AUC0-last) will be derived from multiple blood sampling pre- and post-product use, and corrected for baseline nicotine concentration.
Interventions
OTHERNicorette® inhalator
Subjects will inhale the Nicorette® inhalator (15 mg) at the rate of one deep inhalation every 15 seconds on average, over approximately 20 minutes (80 inhalations in total).
OTHERP3L
Subjects will inhale P3L (50 µg/puff, 80 µg/puff and 150 µg/puff) at the rate of one inhalation every 30 seconds on average, over approximately 6 minutes (i.e., 12 inhalations in total).
Sponsors
Philip Morris Products S.A.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Subject is Caucasian * Smoking, healthy subject as judged by the Investigator * Subject smoked at least 10 commercially available non-menthol cigarettes (CCs) per day for the last 4 weeks * Subject has smoked for at least the last 3 years prior to screening * Subject does not plan to quit smoking in the next 3 months
Exclusion criteria
* As per Investigator judgment, the subject cannot participate in the study for any reason (e.g., medical, psychiatric, and/or social reason) * Subject has donated or been in receipt of whole blood or blood products within 3 months prior to Admission Visit * Female subject is pregnant or breast feeding * Female subject does not agree to use an acceptable method of effective contraception * Female subject uses estrogen-containing hormonal contraception or hormone replacement therapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Concentration-time Curve From Start of Product Use to the Last Quantifiable Time Point (AUC0-last) of Nicotine Following Single Use of P3L 150 µg/Puff | Visit 6: blood taken at 45, 30 and 15 minutes prior to T0 and 2, 4, 7, 10, 15, 20, 30, 40, 50, 60, 120, and 240 minutes after T0. | T0 = start of product use. Derived from multiple blood sampling pre- and post-product use on Visit 6 (over 240 minutes post-product use). Geometric Least Squares (geometric LS) means are provided. |
| Maximum Concentration (Cmax) of Nicotine Following Single Use of Nicorette® Inhalator | Visit 3: blood taken at 45, 30 and 15 minutes prior to T0 and 2, 4, 7, 10, 15, 20, 30, 40, 50, 60, 120, and 240 minutes after T0. | T0 = start of product use. Derived from multiple blood sampling pre- and post-product use on Visit 3 (over 240 minutes post-product use). Geometric Least Squares (geometric LS) means are provided. |
| Maximum Concentration (Cmax) of Nicotine Following Single Use of P3L 50 µg/Puff | Visit 4: blood taken at 45, 30 and 15 minutes prior to T0 and 2, 4, 7, 10, 15, 20, 30, 40, 50, 60, 120, and 240 minutes after T0. | T0 = start of product use. Derived from multiple blood sampling pre- and post-product use on Visit 4 (over 240 minutes post-product use). Geometric Least Squares (geometric LS) means are provided. |
| Maximum Concentration (Cmax) of Nicotine Following Single Use of P3L 80 µg/Puff | Visit 5: blood taken at 45, 30 and 15 minutes prior to T0 and 2, 4, 7, 10, 15, 20, 30, 40, 50, 60, 120, and 240 minutes after T0. | T0 = start of product use. Derived from multiple blood sampling pre- and post-product use on Visit 5 (over 240 minutes post-product use). Geometric Least Squares (geometric LS) means are provided. |
| Maximum Concentration (Cmax) of Nicotine Following Single Use of P3L 150 µg/Puff | Visit 6: blood taken at 45, 30 and 15 minutes prior to T0 and 2, 4, 7, 10, 15, 20, 30, 40, 50, 60, 120, and 240 minutes after T0. | T0 = start of product use. Derived from multiple blood sampling pre- and post-product use on Visit 6 (over 240 minutes post-product use). Geometric Least Squares (geometric LS) means are provided. |
| Time to the Maximum Concentration (Tmax) of Nicotine Following Single Use of Nicorette® Inhalator | Visit 3: blood taken at 45, 30 and 15 minutes prior to T0 and 2, 4, 7, 10, 15, 20, 30, 40, 50, 60, 120, and 240 minutes after T0. | T0 = start of product use. Derived from multiple blood sampling pre- and post-product use on Visit 3 (over 240 minutes post-product use). |
| Time to the Maximum Concentration (Tmax) of Nicotine Following Single Use of P3L 50 µg/Puff | Visit 4: blood taken at 45, 30 and 15 minutes prior to T0 and 2, 4, 7, 10, 15, 20, 30, 40, 50, 60, 120, and 240 minutes after T0. | T0 = start of product use. Derived from multiple blood sampling pre- and post-product use on Visit 4 (over 240 minutes post-product use). |
| Time to the Maximum Concentration (Tmax) of Nicotine Following Single Use of P3L 80 µg/Puff | Visit 5: blood taken at 45, 30 and 15 minutes prior to T0 and 2, 4, 7, 10, 15, 20, 30, 40, 50, 60, 120, and 240 minutes after T0. | T0 = start of product use. Derived from multiple blood sampling pre- and post-product use on Visit 5 (over 240 minutes post-product use). |
| Time to the Maximum Concentration (Tmax) of Nicotine Following Single Use of P3L 150 µg/Puff | Visit 6: blood taken at 45, 30 and 15 minutes prior to T0 and 2, 4, 7, 10, 15, 20, 30, 40, 50, 60, 120, and 240 minutes after T0. | T0 = start of product use. Derived from multiple blood sampling pre- and post-product use on Visit 6 (over 240 minutes post-product use). |
| Area Under the Concentration-time Curve From Start of Product Use to the Last Quantifiable Time Point (AUC0-last) of Nicotine Following Single Use of Nicorette® Inhalator | Visit 3: blood taken at 45, 30 and 15 minutes prior to T0 and 2, 4, 7, 10, 15, 20, 30, 40, 50, 60, 120, and 240 minutes after T0. | T0 = start of product use. Derived from multiple blood sampling pre- and post-product use on Visit 3 (over 240 minutes post-product use). Geometric Least Squares (geometric LS) means are provided. |
| Area Under the Concentration-time Curve From Start of Product Use to the Last Quantifiable Time Point (AUC0-last) of Nicotine Following Single Use of P3L 50 µg/Puff | Visit 4: blood taken at 45, 30 and 15 minutes prior to T0 and 2, 4, 7, 10, 15, 20, 30, 40, 50, 60, 120, and 240 minutes after T0. | T0 = start of product use. Derived from multiple blood sampling pre- and post-product use on Visit 4 (over 240 minutes post-product use). Geometric Least Squares (geometric LS) means are provided. |
| Area Under the Concentration-time Curve From Start of Product Use to the Last Quantifiable Time Point (AUC0-last) of Nicotine Following Single Use of P3L 80 µg/Puff | Visit 5: blood taken at 45, 30 and 15 minutes prior to T0 and 2, 4, 7, 10, 15, 20, 30, 40, 50, 60, 120, and 240 minutes after T0. | T0 = start of product use. Derived from multiple blood sampling pre- and post-product use on Visit 5 (over 240 minutes post-product use). Geometric Least Squares (geometric LS) means are provided. |
| Area Under the Concentration-time Curve From Start of Product Use to 10 Minutes After Start of Product Use (AUC0-10) of Nicotine Following Single Use of Nicorette® Inhalator | Visit 3: blood taken at 45, 30 and 15 minutes prior to T0 and 2, 4, 7, and 10 minutes after T0. | T0 = start of product use. Derived from multiple blood sampling pre- and post-product use on Visit 3 (over 240 minutes post-product use). Geometric Least Squares (geometric LS) means are provided. |
| Area Under the Concentration-time Curve From Start of Product Use to 10 Minutes After Start of Product Use (AUC0-10) of Nicotine Following Single Use of P3L 50 µg/Puff | Visit 4: blood taken at 45, 30 and 15 minutes prior to T0 and 2, 4, 7, and 10 minutes after T0. | T0 = start of product use. Derived from multiple blood sampling pre- and post-product use on Visit 4 (over 240 minutes post-product use). Geometric Least Squares (geometric LS) means are provided. |
| Area Under the Concentration-time Curve From Start of Product Use to 10 Minutes After Start of Product Use (AUC0-10) of Nicotine Following Single Use of P3L 80 µg/Puff | Visit 5: blood taken at 45, 30 and 15 minutes prior to T0 and 2, 4, 7, and 10 minutes after T0. | T0 = start of product use. Derived from multiple blood sampling pre- and post-product use on Visit 5 (over 240 minutes post-product use). Geometric Least Squares (geometric LS) means are provided. |
| Area Under the Concentration-time Curve From Start of Product Use to 10 Minutes After Start of Product Use (AUC0-10) of Nicotine Following Single Use of P3L 150 µg/Puff | Visit 6: blood taken at 45, 30 and 15 minutes prior to T0 and 2, 4, 7, and 10 minutes after T0. | T0 = start of product use. Derived from multiple blood sampling pre- and post-product use on Visit 6 (over 240 minutes post-product use). Geometric Least Squares (geometric LS) means are provided. |
Countries
New Zealand
Participant flow
Recruitment details
Study initiated (1st subject screened): 07 October 2015 At admission, all the subjects were to try the P3L (50 μg/puff) and Nicorette® inhalator. Smoking or use of any tobacco/nicotine-containing products or electronic cigarettes, apart from product use assigned on the assessment days, was not allowed during the visits on site.
Pre-assignment details
Enrolled population = 16 subjects All enrolled subjects met all of the inclusion and none of the exclusion criteria for the study.
Participants by arm
| Arm | Count |
|---|---|
| Nicorette® Inhalator Then P3L Each subject will use the Nicorette® inhalator (15 mg) on Visit 3, and then use the P3L aerosol at nicotine dose levels of approximately 50 µg/puff, 80 µg/puff and 150 µg/puff on Visits 4, 5 and 6, respectively.
Nicorette® inhalator: Subjects will inhale the Nicorette® inhalator (15 mg) at the rate of one deep inhalation every 15 seconds on average, over approximately 20 minutes (80 inhalations in total).
P3L: Subjects will inhale P3L (50 µg/puff, 80 µg/puff and 150 µg/puff) at the rate of one inhalation every 30 seconds on average, over approximately 6 minutes (i.e., 12 inhalations in total). | 15 |
| Total | 15 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Physician Decision | 1 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Nicorette® Inhalator Then P3L |
|---|---|
| Age, Continuous | 39.8 years STANDARD_DEVIATION 13.83 |
| Daily CC consumption at Screening 10 to 19 cig/day | 9 Participants |
| Daily CC consumption at Screening > 19 cig/day | 6 Participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 7 / 16 | 3 / 15 | 4 / 15 | 4 / 14 | 8 / 14 | 2 / 16 |
| serious Total, serious adverse events | 0 / 16 | 0 / 15 | 0 / 15 | 0 / 14 | 0 / 14 | 0 / 16 |
Outcome results
Primary
Area Under the Concentration-time Curve From Start of Product Use to 10 Minutes After Start of Product Use (AUC0-10) of Nicotine Following Single Use of Nicorette® Inhalator
T0 = start of product use. Derived from multiple blood sampling pre- and post-product use on Visit 3 (over 240 minutes post-product use). Geometric Least Squares (geometric LS) means are provided.
Time frame: Visit 3: blood taken at 45, 30 and 15 minutes prior to T0 and 2, 4, 7, and 10 minutes after T0.
Population: PK population: all the subjects who have signed the informed consent, completed at least one P3L product use period and for whom at least one PK parameter can been derived.~=\> 16 subjects - 1 subject withdrew after the product test at the admission visit =15 subjects
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Nicorette® Inhalator | Area Under the Concentration-time Curve From Start of Product Use to 10 Minutes After Start of Product Use (AUC0-10) of Nicotine Following Single Use of Nicorette® Inhalator | 0.124 h*ng/mL |
Primary
Area Under the Concentration-time Curve From Start of Product Use to 10 Minutes After Start of Product Use (AUC0-10) of Nicotine Following Single Use of P3L 150 µg/Puff
T0 = start of product use. Derived from multiple blood sampling pre- and post-product use on Visit 6 (over 240 minutes post-product use). Geometric Least Squares (geometric LS) means are provided.
Time frame: Visit 6: blood taken at 45, 30 and 15 minutes prior to T0 and 2, 4, 7, and 10 minutes after T0.
Population: PK population: all the subjects who have signed the informed consent, completed at least one P3L product use period and for whom at least one PK parameter can been derived.~=\> 16 subjects - 1 subject withdrew after the product test at the admission visit - 1 subject discontinued by the Principal Investigator = 14 subjects
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Nicorette® Inhalator | Area Under the Concentration-time Curve From Start of Product Use to 10 Minutes After Start of Product Use (AUC0-10) of Nicotine Following Single Use of P3L 150 µg/Puff | 1.040 h*ng/mL |
Primary
Area Under the Concentration-time Curve From Start of Product Use to 10 Minutes After Start of Product Use (AUC0-10) of Nicotine Following Single Use of P3L 50 µg/Puff
T0 = start of product use. Derived from multiple blood sampling pre- and post-product use on Visit 4 (over 240 minutes post-product use). Geometric Least Squares (geometric LS) means are provided.
Time frame: Visit 4: blood taken at 45, 30 and 15 minutes prior to T0 and 2, 4, 7, and 10 minutes after T0.
Population: PK population: all the subjects who have signed the informed consent, completed at least one P3L product use period and for whom at least one PK parameter can been derived.~=\> 16 subjects - 1 subject withdrew after the product test at the admission visit =15 subjects
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Nicorette® Inhalator | Area Under the Concentration-time Curve From Start of Product Use to 10 Minutes After Start of Product Use (AUC0-10) of Nicotine Following Single Use of P3L 50 µg/Puff | 1.028 h*ng/mL |
Primary
Area Under the Concentration-time Curve From Start of Product Use to 10 Minutes After Start of Product Use (AUC0-10) of Nicotine Following Single Use of P3L 80 µg/Puff
T0 = start of product use. Derived from multiple blood sampling pre- and post-product use on Visit 5 (over 240 minutes post-product use). Geometric Least Squares (geometric LS) means are provided.
Time frame: Visit 5: blood taken at 45, 30 and 15 minutes prior to T0 and 2, 4, 7, and 10 minutes after T0.
Population: PK population: all the subjects who have signed the informed consent, completed at least one P3L product use period and for whom at least one PK parameter can been derived.~=\> 16 subjects - 1 subject withdrew after the product test at the admission visit - 1 subject discontinued by the Principal Investigator = 14 subjects
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Nicorette® Inhalator | Area Under the Concentration-time Curve From Start of Product Use to 10 Minutes After Start of Product Use (AUC0-10) of Nicotine Following Single Use of P3L 80 µg/Puff | 1.157 h*ng/mL |
Primary
Area Under the Concentration-time Curve From Start of Product Use to the Last Quantifiable Time Point (AUC0-last) of Nicotine Following Single Use of Nicorette® Inhalator
T0 = start of product use. Derived from multiple blood sampling pre- and post-product use on Visit 3 (over 240 minutes post-product use). Geometric Least Squares (geometric LS) means are provided.
Time frame: Visit 3: blood taken at 45, 30 and 15 minutes prior to T0 and 2, 4, 7, 10, 15, 20, 30, 40, 50, 60, 120, and 240 minutes after T0.
Population: PK population: all the subjects who have signed the informed consent, completed at least one P3L product use period and for whom at least one PK parameter can been derived.~=\> 16 subjects - 1 subject withdrew after the product test at the admission visit =15 subjects
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Nicorette® Inhalator | Area Under the Concentration-time Curve From Start of Product Use to the Last Quantifiable Time Point (AUC0-last) of Nicotine Following Single Use of Nicorette® Inhalator | 12.323 h*ng/mL |
Primary
Area Under the Concentration-time Curve From Start of Product Use to the Last Quantifiable Time Point (AUC0-last) of Nicotine Following Single Use of P3L 150 µg/Puff
T0 = start of product use. Derived from multiple blood sampling pre- and post-product use on Visit 6 (over 240 minutes post-product use). Geometric Least Squares (geometric LS) means are provided.
Time frame: Visit 6: blood taken at 45, 30 and 15 minutes prior to T0 and 2, 4, 7, 10, 15, 20, 30, 40, 50, 60, 120, and 240 minutes after T0.
Population: PK population: all the subjects who have signed the informed consent, completed at least one P3L product use period and for whom at least one PK parameter can been derived.~=\> 16 subjects - 1 subject withdrew after the product test at the admission visit - 1 subject discontinued by the Principal Investigator = 14 subjects
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Nicorette® Inhalator | Area Under the Concentration-time Curve From Start of Product Use to the Last Quantifiable Time Point (AUC0-last) of Nicotine Following Single Use of P3L 150 µg/Puff | 9.983 h*ng/mL |
Primary
Area Under the Concentration-time Curve From Start of Product Use to the Last Quantifiable Time Point (AUC0-last) of Nicotine Following Single Use of P3L 50 µg/Puff
T0 = start of product use. Derived from multiple blood sampling pre- and post-product use on Visit 4 (over 240 minutes post-product use). Geometric Least Squares (geometric LS) means are provided.
Time frame: Visit 4: blood taken at 45, 30 and 15 minutes prior to T0 and 2, 4, 7, 10, 15, 20, 30, 40, 50, 60, 120, and 240 minutes after T0.
Population: PK population: all the subjects who have signed the informed consent, completed at least one P3L product use period and for whom at least one PK parameter can been derived.~=\> 16 subjects - 1 subject withdrew after the product test at the admission visit =15 subjects
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Nicorette® Inhalator | Area Under the Concentration-time Curve From Start of Product Use to the Last Quantifiable Time Point (AUC0-last) of Nicotine Following Single Use of P3L 50 µg/Puff | 9.943 h*ng/mL |
Primary
Area Under the Concentration-time Curve From Start of Product Use to the Last Quantifiable Time Point (AUC0-last) of Nicotine Following Single Use of P3L 80 µg/Puff
T0 = start of product use. Derived from multiple blood sampling pre- and post-product use on Visit 5 (over 240 minutes post-product use). Geometric Least Squares (geometric LS) means are provided.
Time frame: Visit 5: blood taken at 45, 30 and 15 minutes prior to T0 and 2, 4, 7, 10, 15, 20, 30, 40, 50, 60, 120, and 240 minutes after T0.
Population: PK population: all the subjects who have signed the informed consent, completed at least one P3L product use period and for whom at least one PK parameter can been derived.~=\> 16 subjects - 1 subject withdrew after the product test at the admission visit - 1 subject discontinued by the Principal Investigator = 14 subjects
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Nicorette® Inhalator | Area Under the Concentration-time Curve From Start of Product Use to the Last Quantifiable Time Point (AUC0-last) of Nicotine Following Single Use of P3L 80 µg/Puff | 10.259 h*ng/mL |
Primary
Maximum Concentration (Cmax) of Nicotine Following Single Use of Nicorette® Inhalator
T0 = start of product use. Derived from multiple blood sampling pre- and post-product use on Visit 3 (over 240 minutes post-product use). Geometric Least Squares (geometric LS) means are provided.
Time frame: Visit 3: blood taken at 45, 30 and 15 minutes prior to T0 and 2, 4, 7, 10, 15, 20, 30, 40, 50, 60, 120, and 240 minutes after T0.
Population: PK population: all the subjects who have signed the informed consent, completed at least one P3L product use period and for whom at least one PK parameter can been derived.~=\> 16 subjects - 1 subject withdrew after the product test at the admission visit =15 subjects
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Nicorette® Inhalator | Maximum Concentration (Cmax) of Nicotine Following Single Use of Nicorette® Inhalator | 6.095 ng/mL |
Primary
Maximum Concentration (Cmax) of Nicotine Following Single Use of P3L 150 µg/Puff
T0 = start of product use. Derived from multiple blood sampling pre- and post-product use on Visit 6 (over 240 minutes post-product use). Geometric Least Squares (geometric LS) means are provided.
Time frame: Visit 6: blood taken at 45, 30 and 15 minutes prior to T0 and 2, 4, 7, 10, 15, 20, 30, 40, 50, 60, 120, and 240 minutes after T0.
Population: PK population: all the subjects who have signed the informed consent, completed at least one P3L product use period and for whom at least one PK parameter can been derived.~=\> 16 subjects - 1 subject withdrew after the product test at the admission visit - 1 subject discontinued by the Principal Investigator = 14 subjects
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Nicorette® Inhalator | Maximum Concentration (Cmax) of Nicotine Following Single Use of P3L 150 µg/Puff | 9.805 ng/mL |
Primary
Maximum Concentration (Cmax) of Nicotine Following Single Use of P3L 50 µg/Puff
T0 = start of product use. Derived from multiple blood sampling pre- and post-product use on Visit 4 (over 240 minutes post-product use). Geometric Least Squares (geometric LS) means are provided.
Time frame: Visit 4: blood taken at 45, 30 and 15 minutes prior to T0 and 2, 4, 7, 10, 15, 20, 30, 40, 50, 60, 120, and 240 minutes after T0.
Population: PK population: all the subjects who have signed the informed consent, completed at least one P3L product use period and for whom at least one PK parameter can been derived.~=\> 16 subjects - 1 subject withdrew after the product test at the admission visit =15 subjects
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Nicorette® Inhalator | Maximum Concentration (Cmax) of Nicotine Following Single Use of P3L 50 µg/Puff | 9.659 ng/mL |
Primary
Maximum Concentration (Cmax) of Nicotine Following Single Use of P3L 80 µg/Puff
T0 = start of product use. Derived from multiple blood sampling pre- and post-product use on Visit 5 (over 240 minutes post-product use). Geometric Least Squares (geometric LS) means are provided.
Time frame: Visit 5: blood taken at 45, 30 and 15 minutes prior to T0 and 2, 4, 7, 10, 15, 20, 30, 40, 50, 60, 120, and 240 minutes after T0.
Population: PK population: all the subjects who have signed the informed consent, completed at least one P3L product use period and for whom at least one PK parameter can been derived.~=\> 16 subjects - 1 subject withdrew after the product test at the admission visit - 1 subject discontinued by the Principal Investigator = 14 subjects
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Nicorette® Inhalator | Maximum Concentration (Cmax) of Nicotine Following Single Use of P3L 80 µg/Puff | 11.145 ng/mL |
Primary
Time to the Maximum Concentration (Tmax) of Nicotine Following Single Use of Nicorette® Inhalator
T0 = start of product use. Derived from multiple blood sampling pre- and post-product use on Visit 3 (over 240 minutes post-product use).
Time frame: Visit 3: blood taken at 45, 30 and 15 minutes prior to T0 and 2, 4, 7, 10, 15, 20, 30, 40, 50, 60, 120, and 240 minutes after T0.
Population: PK population: all the subjects who have signed the informed consent, completed at least one P3L product use period and for whom at least one PK parameter can been derived.~=\> 16 subjects - 1 subject withdrew after the product test at the admission visit =15 subjects
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Nicorette® Inhalator | Time to the Maximum Concentration (Tmax) of Nicotine Following Single Use of Nicorette® Inhalator | 30.0 minutes |
Primary
Time to the Maximum Concentration (Tmax) of Nicotine Following Single Use of P3L 150 µg/Puff
T0 = start of product use. Derived from multiple blood sampling pre- and post-product use on Visit 6 (over 240 minutes post-product use).
Time frame: Visit 6: blood taken at 45, 30 and 15 minutes prior to T0 and 2, 4, 7, 10, 15, 20, 30, 40, 50, 60, 120, and 240 minutes after T0.
Population: PK population: all the subjects who have signed the informed consent, completed at least one P3L product use period and for whom at least one PK parameter can been derived.~=\> 16 subjects - 1 subject withdrew after the product test at the admission visit - 1 subject discontinued by the Principal Investigator = 14 subjects
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Nicorette® Inhalator | Time to the Maximum Concentration (Tmax) of Nicotine Following Single Use of P3L 150 µg/Puff | 7.0 minutes |
Primary
Time to the Maximum Concentration (Tmax) of Nicotine Following Single Use of P3L 50 µg/Puff
T0 = start of product use. Derived from multiple blood sampling pre- and post-product use on Visit 4 (over 240 minutes post-product use).
Time frame: Visit 4: blood taken at 45, 30 and 15 minutes prior to T0 and 2, 4, 7, 10, 15, 20, 30, 40, 50, 60, 120, and 240 minutes after T0.
Population: PK population: all the subjects who have signed the informed consent, completed at least one P3L product use period and for whom at least one PK parameter can been derived.~=\> 16 subjects - 1 subject withdrew after the product test at the admission visit =15 subjects
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Nicorette® Inhalator | Time to the Maximum Concentration (Tmax) of Nicotine Following Single Use of P3L 50 µg/Puff | 7.0 minutes |
Primary
Time to the Maximum Concentration (Tmax) of Nicotine Following Single Use of P3L 80 µg/Puff
T0 = start of product use. Derived from multiple blood sampling pre- and post-product use on Visit 5 (over 240 minutes post-product use).
Time frame: Visit 5: blood taken at 45, 30 and 15 minutes prior to T0 and 2, 4, 7, 10, 15, 20, 30, 40, 50, 60, 120, and 240 minutes after T0.
Population: PK population: all the subjects who have signed the informed consent, completed at least one P3L product use period and for whom at least one PK parameter can been derived.~=\> 16 subjects - 1 subject withdrew after the product test at the admission visit - 1 subject discontinued by the Principal Investigator = 14 subjects
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Nicorette® Inhalator | Time to the Maximum Concentration (Tmax) of Nicotine Following Single Use of P3L 80 µg/Puff | 7.0 minutes |