Trial Outcomes & Findings for Nicotine Pharmacokinetic and Pharmacodynamics Profile, Safety and Tolerability of P3L (NCT NCT02532374)
NCT ID: NCT02532374
Last Updated: 2020-02-24
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
16 participants
Primary outcome timeframe
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.
Results posted on
2020-02-24
Participant Flow
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.
Enrolled population = 16 subjects All enrolled subjects met all of the inclusion and none of the exclusion criteria for the study.
Participant milestones
| Measure |
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).
|
|---|---|
|
Overall Study
STARTED
|
16
|
|
Overall Study
Nicorette Inhalator (Visit 3)
|
15
|
|
Overall Study
P3L 50 μg/Puff (Visit 4)
|
15
|
|
Overall Study
P3L 80 μg/Puff (Visit 5)
|
14
|
|
Overall Study
P3L150 μg/Puff (Visit 6)
|
14
|
|
Overall Study
COMPLETED
|
14
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
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).
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Physician Decision
|
1
|
Baseline Characteristics
Nicotine Pharmacokinetic and Pharmacodynamics Profile, Safety and Tolerability of P3L
Baseline characteristics by cohort
| Measure |
Nicorette® Inhalator Then P3L
n=15 Participants
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).
|
|---|---|
|
Age, Continuous
|
39.8 years
STANDARD_DEVIATION 13.83 • n=99 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=99 Participants
|
|
Daily CC consumption at Screening
10 to 19 cig/day
|
9 Participants
n=99 Participants
|
|
Daily CC consumption at Screening
> 19 cig/day
|
6 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 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
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.
Outcome measures
| Measure |
Nicorette® Inhalator
n=15 Participants
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).
|
|---|---|
|
Maximum Concentration (Cmax) of Nicotine Following Single Use of Nicorette® Inhalator
|
6.095 ng/mL
Interval 4.243 to 8.755
|
PRIMARY outcome
Timeframe: 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
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.
Outcome measures
| Measure |
Nicorette® Inhalator
n=15 Participants
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).
|
|---|---|
|
Maximum Concentration (Cmax) of Nicotine Following Single Use of P3L 50 µg/Puff
|
9.659 ng/mL
Interval 6.724 to 13.874
|
PRIMARY outcome
Timeframe: 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
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.
Outcome measures
| Measure |
Nicorette® Inhalator
n=14 Participants
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).
|
|---|---|
|
Maximum Concentration (Cmax) of Nicotine Following Single Use of P3L 80 µg/Puff
|
11.145 ng/mL
Interval 7.701 to 16.128
|
PRIMARY outcome
Timeframe: 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
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.
Outcome measures
| Measure |
Nicorette® Inhalator
n=14 Participants
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).
|
|---|---|
|
Maximum Concentration (Cmax) of Nicotine Following Single Use of P3L 150 µg/Puff
|
9.805 ng/mL
Interval 6.775 to 14.189
|
PRIMARY outcome
Timeframe: 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
T0 = start of product use. Derived from multiple blood sampling pre- and post-product use on Visit 3 (over 240 minutes post-product use).
Outcome measures
| Measure |
Nicorette® Inhalator
n=15 Participants
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).
|
|---|---|
|
Time to the Maximum Concentration (Tmax) of Nicotine Following Single Use of Nicorette® Inhalator
|
30.0 minutes
Interval 20.0 to 40.0
|
PRIMARY outcome
Timeframe: 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
T0 = start of product use. Derived from multiple blood sampling pre- and post-product use on Visit 4 (over 240 minutes post-product use).
Outcome measures
| Measure |
Nicorette® Inhalator
n=15 Participants
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).
|
|---|---|
|
Time to the Maximum Concentration (Tmax) of Nicotine Following Single Use of P3L 50 µg/Puff
|
7.0 minutes
Interval 4.0 to 7.0
|
PRIMARY outcome
Timeframe: 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
T0 = start of product use. Derived from multiple blood sampling pre- and post-product use on Visit 5 (over 240 minutes post-product use).
Outcome measures
| Measure |
Nicorette® Inhalator
n=14 Participants
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).
|
|---|---|
|
Time to the Maximum Concentration (Tmax) of Nicotine Following Single Use of P3L 80 µg/Puff
|
7.0 minutes
Interval 7.0 to 7.0
|
PRIMARY outcome
Timeframe: 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
T0 = start of product use. Derived from multiple blood sampling pre- and post-product use on Visit 6 (over 240 minutes post-product use).
Outcome measures
| Measure |
Nicorette® Inhalator
n=14 Participants
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).
|
|---|---|
|
Time to the Maximum Concentration (Tmax) of Nicotine Following Single Use of P3L 150 µg/Puff
|
7.0 minutes
Interval 4.0 to 7.0
|
PRIMARY outcome
Timeframe: 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
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.
Outcome measures
| Measure |
Nicorette® Inhalator
n=15 Participants
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).
|
|---|---|
|
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
Interval 9.251 to 16.415
|
PRIMARY outcome
Timeframe: 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
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.
Outcome measures
| Measure |
Nicorette® Inhalator
n=15 Participants
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).
|
|---|---|
|
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
Interval 7.465 to 13.245
|
PRIMARY outcome
Timeframe: 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
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.
Outcome measures
| Measure |
Nicorette® Inhalator
n=14 Participants
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).
|
|---|---|
|
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
Interval 7.644 to 13.77
|
PRIMARY outcome
Timeframe: 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
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.
Outcome measures
| Measure |
Nicorette® Inhalator
n=14 Participants
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).
|
|---|---|
|
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
Interval 7.438 to 13.399
|
PRIMARY outcome
Timeframe: 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
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.
Outcome measures
| Measure |
Nicorette® Inhalator
n=15 Participants
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).
|
|---|---|
|
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
Interval 0.077 to 0.2
|
PRIMARY outcome
Timeframe: 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
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.
Outcome measures
| Measure |
Nicorette® Inhalator
n=15 Participants
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).
|
|---|---|
|
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
Interval 0.64 to 1.65
|
PRIMARY outcome
Timeframe: 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
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.
Outcome measures
| Measure |
Nicorette® Inhalator
n=14 Participants
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).
|
|---|---|
|
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
Interval 0.714 to 1.874
|
PRIMARY outcome
Timeframe: 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
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.
Outcome measures
| Measure |
Nicorette® Inhalator
n=14 Participants
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).
|
|---|---|
|
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
Interval 0.642 to 1.684
|
Adverse Events
Enrolment Period
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Nicorette® Inhalator Period
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
P3L 50 µg/Puff Period
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
P3L 80 µg/Puff Period
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
P3L 150 µg/Puff Period
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Safety Follow-up Period
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Enrolment Period
n=16 participants at risk
All subjects who have signed the ICF, and who have been exposed to P3L and/or Nicorette® inhalator.
Product test period - from enrolment to admission.
|
Nicorette® Inhalator Period
n=15 participants at risk
Subjects inhaled 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 50 µg/Puff Period
n=15 participants at risk
Subjects inhaled P3L 50 µg/puff at the rate of one inhalation every 30 seconds on average, over approximately 6 minutes (i.e., 12 inhalations in total).
|
P3L 80 µg/Puff Period
n=14 participants at risk
Subjects inhaled P3L 80 µg/puff at the rate of one inhalation every 30 seconds on average, over approximately 6 minutes (i.e., 12 inhalations in total).
|
P3L 150 µg/Puff Period
n=14 participants at risk
Subjects inhaled P3L 150 µg/puff at the rate of one inhalation every 30 seconds on average, over approximately 6 minutes (i.e., 12 inhalations in total).
|
Safety Follow-up Period
n=16 participants at risk
All subjects who have signed the ICF, and who have been exposed to P3L and/or Nicorette® inhalator entered a 7-day safety follow-up period during which (serious) adverse events can be spontaneously reported by the subjects.
|
|---|---|---|---|---|---|---|
|
Investigations
Blood Albumin Decreased
|
0.00%
0/16 • From the informed consent form (ICF) signature until the end of the safety follow-up period, up to 49 days (see the section "Detailed Description" for information on the study duration). The adverse events were tabulated for the safety population for: * Enrolment period (product test period, from enrolment to admission) * Nicorette® inhalator period * P3L 50 μg/puff period * P3L 80 μg/puff period * P3L 150 μg/puff period * Safety follow-up period
The safety was assessed in the safety population, consisting of all subjects who have signed the ICF, and who have been exposed to P3L and/or Nicorette® inhalator. Safety population = 16 subjects. It should be noted that the assessment of clinical chemistry parameters occurred only at admission and Visit 6/early termination. Consequently, all safety laboratories occurring with product use where reported as pertaining to the last exposure period, i.e. P3L 150 μg/puff period.
|
0.00%
0/15 • From the informed consent form (ICF) signature until the end of the safety follow-up period, up to 49 days (see the section "Detailed Description" for information on the study duration). The adverse events were tabulated for the safety population for: * Enrolment period (product test period, from enrolment to admission) * Nicorette® inhalator period * P3L 50 μg/puff period * P3L 80 μg/puff period * P3L 150 μg/puff period * Safety follow-up period
The safety was assessed in the safety population, consisting of all subjects who have signed the ICF, and who have been exposed to P3L and/or Nicorette® inhalator. Safety population = 16 subjects. It should be noted that the assessment of clinical chemistry parameters occurred only at admission and Visit 6/early termination. Consequently, all safety laboratories occurring with product use where reported as pertaining to the last exposure period, i.e. P3L 150 μg/puff period.
|
0.00%
0/15 • From the informed consent form (ICF) signature until the end of the safety follow-up period, up to 49 days (see the section "Detailed Description" for information on the study duration). The adverse events were tabulated for the safety population for: * Enrolment period (product test period, from enrolment to admission) * Nicorette® inhalator period * P3L 50 μg/puff period * P3L 80 μg/puff period * P3L 150 μg/puff period * Safety follow-up period
The safety was assessed in the safety population, consisting of all subjects who have signed the ICF, and who have been exposed to P3L and/or Nicorette® inhalator. Safety population = 16 subjects. It should be noted that the assessment of clinical chemistry parameters occurred only at admission and Visit 6/early termination. Consequently, all safety laboratories occurring with product use where reported as pertaining to the last exposure period, i.e. P3L 150 μg/puff period.
|
0.00%
0/14 • From the informed consent form (ICF) signature until the end of the safety follow-up period, up to 49 days (see the section "Detailed Description" for information on the study duration). The adverse events were tabulated for the safety population for: * Enrolment period (product test period, from enrolment to admission) * Nicorette® inhalator period * P3L 50 μg/puff period * P3L 80 μg/puff period * P3L 150 μg/puff period * Safety follow-up period
The safety was assessed in the safety population, consisting of all subjects who have signed the ICF, and who have been exposed to P3L and/or Nicorette® inhalator. Safety population = 16 subjects. It should be noted that the assessment of clinical chemistry parameters occurred only at admission and Visit 6/early termination. Consequently, all safety laboratories occurring with product use where reported as pertaining to the last exposure period, i.e. P3L 150 μg/puff period.
|
28.6%
4/14 • Number of events 4 • From the informed consent form (ICF) signature until the end of the safety follow-up period, up to 49 days (see the section "Detailed Description" for information on the study duration). The adverse events were tabulated for the safety population for: * Enrolment period (product test period, from enrolment to admission) * Nicorette® inhalator period * P3L 50 μg/puff period * P3L 80 μg/puff period * P3L 150 μg/puff period * Safety follow-up period
The safety was assessed in the safety population, consisting of all subjects who have signed the ICF, and who have been exposed to P3L and/or Nicorette® inhalator. Safety population = 16 subjects. It should be noted that the assessment of clinical chemistry parameters occurred only at admission and Visit 6/early termination. Consequently, all safety laboratories occurring with product use where reported as pertaining to the last exposure period, i.e. P3L 150 μg/puff period.
|
0.00%
0/16 • From the informed consent form (ICF) signature until the end of the safety follow-up period, up to 49 days (see the section "Detailed Description" for information on the study duration). The adverse events were tabulated for the safety population for: * Enrolment period (product test period, from enrolment to admission) * Nicorette® inhalator period * P3L 50 μg/puff period * P3L 80 μg/puff period * P3L 150 μg/puff period * Safety follow-up period
The safety was assessed in the safety population, consisting of all subjects who have signed the ICF, and who have been exposed to P3L and/or Nicorette® inhalator. Safety population = 16 subjects. It should be noted that the assessment of clinical chemistry parameters occurred only at admission and Visit 6/early termination. Consequently, all safety laboratories occurring with product use where reported as pertaining to the last exposure period, i.e. P3L 150 μg/puff period.
|
|
Investigations
Blood Triglycerides Increased
|
12.5%
2/16 • Number of events 2 • From the informed consent form (ICF) signature until the end of the safety follow-up period, up to 49 days (see the section "Detailed Description" for information on the study duration). The adverse events were tabulated for the safety population for: * Enrolment period (product test period, from enrolment to admission) * Nicorette® inhalator period * P3L 50 μg/puff period * P3L 80 μg/puff period * P3L 150 μg/puff period * Safety follow-up period
The safety was assessed in the safety population, consisting of all subjects who have signed the ICF, and who have been exposed to P3L and/or Nicorette® inhalator. Safety population = 16 subjects. It should be noted that the assessment of clinical chemistry parameters occurred only at admission and Visit 6/early termination. Consequently, all safety laboratories occurring with product use where reported as pertaining to the last exposure period, i.e. P3L 150 μg/puff period.
|
0.00%
0/15 • From the informed consent form (ICF) signature until the end of the safety follow-up period, up to 49 days (see the section "Detailed Description" for information on the study duration). The adverse events were tabulated for the safety population for: * Enrolment period (product test period, from enrolment to admission) * Nicorette® inhalator period * P3L 50 μg/puff period * P3L 80 μg/puff period * P3L 150 μg/puff period * Safety follow-up period
The safety was assessed in the safety population, consisting of all subjects who have signed the ICF, and who have been exposed to P3L and/or Nicorette® inhalator. Safety population = 16 subjects. It should be noted that the assessment of clinical chemistry parameters occurred only at admission and Visit 6/early termination. Consequently, all safety laboratories occurring with product use where reported as pertaining to the last exposure period, i.e. P3L 150 μg/puff period.
|
0.00%
0/15 • From the informed consent form (ICF) signature until the end of the safety follow-up period, up to 49 days (see the section "Detailed Description" for information on the study duration). The adverse events were tabulated for the safety population for: * Enrolment period (product test period, from enrolment to admission) * Nicorette® inhalator period * P3L 50 μg/puff period * P3L 80 μg/puff period * P3L 150 μg/puff period * Safety follow-up period
The safety was assessed in the safety population, consisting of all subjects who have signed the ICF, and who have been exposed to P3L and/or Nicorette® inhalator. Safety population = 16 subjects. It should be noted that the assessment of clinical chemistry parameters occurred only at admission and Visit 6/early termination. Consequently, all safety laboratories occurring with product use where reported as pertaining to the last exposure period, i.e. P3L 150 μg/puff period.
|
0.00%
0/14 • From the informed consent form (ICF) signature until the end of the safety follow-up period, up to 49 days (see the section "Detailed Description" for information on the study duration). The adverse events were tabulated for the safety population for: * Enrolment period (product test period, from enrolment to admission) * Nicorette® inhalator period * P3L 50 μg/puff period * P3L 80 μg/puff period * P3L 150 μg/puff period * Safety follow-up period
The safety was assessed in the safety population, consisting of all subjects who have signed the ICF, and who have been exposed to P3L and/or Nicorette® inhalator. Safety population = 16 subjects. It should be noted that the assessment of clinical chemistry parameters occurred only at admission and Visit 6/early termination. Consequently, all safety laboratories occurring with product use where reported as pertaining to the last exposure period, i.e. P3L 150 μg/puff period.
|
7.1%
1/14 • Number of events 1 • From the informed consent form (ICF) signature until the end of the safety follow-up period, up to 49 days (see the section "Detailed Description" for information on the study duration). The adverse events were tabulated for the safety population for: * Enrolment period (product test period, from enrolment to admission) * Nicorette® inhalator period * P3L 50 μg/puff period * P3L 80 μg/puff period * P3L 150 μg/puff period * Safety follow-up period
The safety was assessed in the safety population, consisting of all subjects who have signed the ICF, and who have been exposed to P3L and/or Nicorette® inhalator. Safety population = 16 subjects. It should be noted that the assessment of clinical chemistry parameters occurred only at admission and Visit 6/early termination. Consequently, all safety laboratories occurring with product use where reported as pertaining to the last exposure period, i.e. P3L 150 μg/puff period.
|
6.2%
1/16 • Number of events 1 • From the informed consent form (ICF) signature until the end of the safety follow-up period, up to 49 days (see the section "Detailed Description" for information on the study duration). The adverse events were tabulated for the safety population for: * Enrolment period (product test period, from enrolment to admission) * Nicorette® inhalator period * P3L 50 μg/puff period * P3L 80 μg/puff period * P3L 150 μg/puff period * Safety follow-up period
The safety was assessed in the safety population, consisting of all subjects who have signed the ICF, and who have been exposed to P3L and/or Nicorette® inhalator. Safety population = 16 subjects. It should be noted that the assessment of clinical chemistry parameters occurred only at admission and Visit 6/early termination. Consequently, all safety laboratories occurring with product use where reported as pertaining to the last exposure period, i.e. P3L 150 μg/puff period.
|
|
Investigations
Blood Glucose Decreased
|
0.00%
0/16 • From the informed consent form (ICF) signature until the end of the safety follow-up period, up to 49 days (see the section "Detailed Description" for information on the study duration). The adverse events were tabulated for the safety population for: * Enrolment period (product test period, from enrolment to admission) * Nicorette® inhalator period * P3L 50 μg/puff period * P3L 80 μg/puff period * P3L 150 μg/puff period * Safety follow-up period
The safety was assessed in the safety population, consisting of all subjects who have signed the ICF, and who have been exposed to P3L and/or Nicorette® inhalator. Safety population = 16 subjects. It should be noted that the assessment of clinical chemistry parameters occurred only at admission and Visit 6/early termination. Consequently, all safety laboratories occurring with product use where reported as pertaining to the last exposure period, i.e. P3L 150 μg/puff period.
|
0.00%
0/15 • From the informed consent form (ICF) signature until the end of the safety follow-up period, up to 49 days (see the section "Detailed Description" for information on the study duration). The adverse events were tabulated for the safety population for: * Enrolment period (product test period, from enrolment to admission) * Nicorette® inhalator period * P3L 50 μg/puff period * P3L 80 μg/puff period * P3L 150 μg/puff period * Safety follow-up period
The safety was assessed in the safety population, consisting of all subjects who have signed the ICF, and who have been exposed to P3L and/or Nicorette® inhalator. Safety population = 16 subjects. It should be noted that the assessment of clinical chemistry parameters occurred only at admission and Visit 6/early termination. Consequently, all safety laboratories occurring with product use where reported as pertaining to the last exposure period, i.e. P3L 150 μg/puff period.
|
0.00%
0/15 • From the informed consent form (ICF) signature until the end of the safety follow-up period, up to 49 days (see the section "Detailed Description" for information on the study duration). The adverse events were tabulated for the safety population for: * Enrolment period (product test period, from enrolment to admission) * Nicorette® inhalator period * P3L 50 μg/puff period * P3L 80 μg/puff period * P3L 150 μg/puff period * Safety follow-up period
The safety was assessed in the safety population, consisting of all subjects who have signed the ICF, and who have been exposed to P3L and/or Nicorette® inhalator. Safety population = 16 subjects. It should be noted that the assessment of clinical chemistry parameters occurred only at admission and Visit 6/early termination. Consequently, all safety laboratories occurring with product use where reported as pertaining to the last exposure period, i.e. P3L 150 μg/puff period.
|
0.00%
0/14 • From the informed consent form (ICF) signature until the end of the safety follow-up period, up to 49 days (see the section "Detailed Description" for information on the study duration). The adverse events were tabulated for the safety population for: * Enrolment period (product test period, from enrolment to admission) * Nicorette® inhalator period * P3L 50 μg/puff period * P3L 80 μg/puff period * P3L 150 μg/puff period * Safety follow-up period
The safety was assessed in the safety population, consisting of all subjects who have signed the ICF, and who have been exposed to P3L and/or Nicorette® inhalator. Safety population = 16 subjects. It should be noted that the assessment of clinical chemistry parameters occurred only at admission and Visit 6/early termination. Consequently, all safety laboratories occurring with product use where reported as pertaining to the last exposure period, i.e. P3L 150 μg/puff period.
|
14.3%
2/14 • Number of events 2 • From the informed consent form (ICF) signature until the end of the safety follow-up period, up to 49 days (see the section "Detailed Description" for information on the study duration). The adverse events were tabulated for the safety population for: * Enrolment period (product test period, from enrolment to admission) * Nicorette® inhalator period * P3L 50 μg/puff period * P3L 80 μg/puff period * P3L 150 μg/puff period * Safety follow-up period
The safety was assessed in the safety population, consisting of all subjects who have signed the ICF, and who have been exposed to P3L and/or Nicorette® inhalator. Safety population = 16 subjects. It should be noted that the assessment of clinical chemistry parameters occurred only at admission and Visit 6/early termination. Consequently, all safety laboratories occurring with product use where reported as pertaining to the last exposure period, i.e. P3L 150 μg/puff period.
|
0.00%
0/16 • From the informed consent form (ICF) signature until the end of the safety follow-up period, up to 49 days (see the section "Detailed Description" for information on the study duration). The adverse events were tabulated for the safety population for: * Enrolment period (product test period, from enrolment to admission) * Nicorette® inhalator period * P3L 50 μg/puff period * P3L 80 μg/puff period * P3L 150 μg/puff period * Safety follow-up period
The safety was assessed in the safety population, consisting of all subjects who have signed the ICF, and who have been exposed to P3L and/or Nicorette® inhalator. Safety population = 16 subjects. It should be noted that the assessment of clinical chemistry parameters occurred only at admission and Visit 6/early termination. Consequently, all safety laboratories occurring with product use where reported as pertaining to the last exposure period, i.e. P3L 150 μg/puff period.
|
|
Investigations
Blood Glucose Increased
|
12.5%
2/16 • Number of events 2 • From the informed consent form (ICF) signature until the end of the safety follow-up period, up to 49 days (see the section "Detailed Description" for information on the study duration). The adverse events were tabulated for the safety population for: * Enrolment period (product test period, from enrolment to admission) * Nicorette® inhalator period * P3L 50 μg/puff period * P3L 80 μg/puff period * P3L 150 μg/puff period * Safety follow-up period
The safety was assessed in the safety population, consisting of all subjects who have signed the ICF, and who have been exposed to P3L and/or Nicorette® inhalator. Safety population = 16 subjects. It should be noted that the assessment of clinical chemistry parameters occurred only at admission and Visit 6/early termination. Consequently, all safety laboratories occurring with product use where reported as pertaining to the last exposure period, i.e. P3L 150 μg/puff period.
|
0.00%
0/15 • From the informed consent form (ICF) signature until the end of the safety follow-up period, up to 49 days (see the section "Detailed Description" for information on the study duration). The adverse events were tabulated for the safety population for: * Enrolment period (product test period, from enrolment to admission) * Nicorette® inhalator period * P3L 50 μg/puff period * P3L 80 μg/puff period * P3L 150 μg/puff period * Safety follow-up period
The safety was assessed in the safety population, consisting of all subjects who have signed the ICF, and who have been exposed to P3L and/or Nicorette® inhalator. Safety population = 16 subjects. It should be noted that the assessment of clinical chemistry parameters occurred only at admission and Visit 6/early termination. Consequently, all safety laboratories occurring with product use where reported as pertaining to the last exposure period, i.e. P3L 150 μg/puff period.
|
0.00%
0/15 • From the informed consent form (ICF) signature until the end of the safety follow-up period, up to 49 days (see the section "Detailed Description" for information on the study duration). The adverse events were tabulated for the safety population for: * Enrolment period (product test period, from enrolment to admission) * Nicorette® inhalator period * P3L 50 μg/puff period * P3L 80 μg/puff period * P3L 150 μg/puff period * Safety follow-up period
The safety was assessed in the safety population, consisting of all subjects who have signed the ICF, and who have been exposed to P3L and/or Nicorette® inhalator. Safety population = 16 subjects. It should be noted that the assessment of clinical chemistry parameters occurred only at admission and Visit 6/early termination. Consequently, all safety laboratories occurring with product use where reported as pertaining to the last exposure period, i.e. P3L 150 μg/puff period.
|
0.00%
0/14 • From the informed consent form (ICF) signature until the end of the safety follow-up period, up to 49 days (see the section "Detailed Description" for information on the study duration). The adverse events were tabulated for the safety population for: * Enrolment period (product test period, from enrolment to admission) * Nicorette® inhalator period * P3L 50 μg/puff period * P3L 80 μg/puff period * P3L 150 μg/puff period * Safety follow-up period
The safety was assessed in the safety population, consisting of all subjects who have signed the ICF, and who have been exposed to P3L and/or Nicorette® inhalator. Safety population = 16 subjects. It should be noted that the assessment of clinical chemistry parameters occurred only at admission and Visit 6/early termination. Consequently, all safety laboratories occurring with product use where reported as pertaining to the last exposure period, i.e. P3L 150 μg/puff period.
|
0.00%
0/14 • From the informed consent form (ICF) signature until the end of the safety follow-up period, up to 49 days (see the section "Detailed Description" for information on the study duration). The adverse events were tabulated for the safety population for: * Enrolment period (product test period, from enrolment to admission) * Nicorette® inhalator period * P3L 50 μg/puff period * P3L 80 μg/puff period * P3L 150 μg/puff period * Safety follow-up period
The safety was assessed in the safety population, consisting of all subjects who have signed the ICF, and who have been exposed to P3L and/or Nicorette® inhalator. Safety population = 16 subjects. It should be noted that the assessment of clinical chemistry parameters occurred only at admission and Visit 6/early termination. Consequently, all safety laboratories occurring with product use where reported as pertaining to the last exposure period, i.e. P3L 150 μg/puff period.
|
0.00%
0/16 • From the informed consent form (ICF) signature until the end of the safety follow-up period, up to 49 days (see the section "Detailed Description" for information on the study duration). The adverse events were tabulated for the safety population for: * Enrolment period (product test period, from enrolment to admission) * Nicorette® inhalator period * P3L 50 μg/puff period * P3L 80 μg/puff period * P3L 150 μg/puff period * Safety follow-up period
The safety was assessed in the safety population, consisting of all subjects who have signed the ICF, and who have been exposed to P3L and/or Nicorette® inhalator. Safety population = 16 subjects. It should be noted that the assessment of clinical chemistry parameters occurred only at admission and Visit 6/early termination. Consequently, all safety laboratories occurring with product use where reported as pertaining to the last exposure period, i.e. P3L 150 μg/puff period.
|
|
Investigations
Blood Bilirubin Increased
|
0.00%
0/16 • From the informed consent form (ICF) signature until the end of the safety follow-up period, up to 49 days (see the section "Detailed Description" for information on the study duration). The adverse events were tabulated for the safety population for: * Enrolment period (product test period, from enrolment to admission) * Nicorette® inhalator period * P3L 50 μg/puff period * P3L 80 μg/puff period * P3L 150 μg/puff period * Safety follow-up period
The safety was assessed in the safety population, consisting of all subjects who have signed the ICF, and who have been exposed to P3L and/or Nicorette® inhalator. Safety population = 16 subjects. It should be noted that the assessment of clinical chemistry parameters occurred only at admission and Visit 6/early termination. Consequently, all safety laboratories occurring with product use where reported as pertaining to the last exposure period, i.e. P3L 150 μg/puff period.
|
0.00%
0/15 • From the informed consent form (ICF) signature until the end of the safety follow-up period, up to 49 days (see the section "Detailed Description" for information on the study duration). The adverse events were tabulated for the safety population for: * Enrolment period (product test period, from enrolment to admission) * Nicorette® inhalator period * P3L 50 μg/puff period * P3L 80 μg/puff period * P3L 150 μg/puff period * Safety follow-up period
The safety was assessed in the safety population, consisting of all subjects who have signed the ICF, and who have been exposed to P3L and/or Nicorette® inhalator. Safety population = 16 subjects. It should be noted that the assessment of clinical chemistry parameters occurred only at admission and Visit 6/early termination. Consequently, all safety laboratories occurring with product use where reported as pertaining to the last exposure period, i.e. P3L 150 μg/puff period.
|
0.00%
0/15 • From the informed consent form (ICF) signature until the end of the safety follow-up period, up to 49 days (see the section "Detailed Description" for information on the study duration). The adverse events were tabulated for the safety population for: * Enrolment period (product test period, from enrolment to admission) * Nicorette® inhalator period * P3L 50 μg/puff period * P3L 80 μg/puff period * P3L 150 μg/puff period * Safety follow-up period
The safety was assessed in the safety population, consisting of all subjects who have signed the ICF, and who have been exposed to P3L and/or Nicorette® inhalator. Safety population = 16 subjects. It should be noted that the assessment of clinical chemistry parameters occurred only at admission and Visit 6/early termination. Consequently, all safety laboratories occurring with product use where reported as pertaining to the last exposure period, i.e. P3L 150 μg/puff period.
|
0.00%
0/14 • From the informed consent form (ICF) signature until the end of the safety follow-up period, up to 49 days (see the section "Detailed Description" for information on the study duration). The adverse events were tabulated for the safety population for: * Enrolment period (product test period, from enrolment to admission) * Nicorette® inhalator period * P3L 50 μg/puff period * P3L 80 μg/puff period * P3L 150 μg/puff period * Safety follow-up period
The safety was assessed in the safety population, consisting of all subjects who have signed the ICF, and who have been exposed to P3L and/or Nicorette® inhalator. Safety population = 16 subjects. It should be noted that the assessment of clinical chemistry parameters occurred only at admission and Visit 6/early termination. Consequently, all safety laboratories occurring with product use where reported as pertaining to the last exposure period, i.e. P3L 150 μg/puff period.
|
7.1%
1/14 • Number of events 1 • From the informed consent form (ICF) signature until the end of the safety follow-up period, up to 49 days (see the section "Detailed Description" for information on the study duration). The adverse events were tabulated for the safety population for: * Enrolment period (product test period, from enrolment to admission) * Nicorette® inhalator period * P3L 50 μg/puff period * P3L 80 μg/puff period * P3L 150 μg/puff period * Safety follow-up period
The safety was assessed in the safety population, consisting of all subjects who have signed the ICF, and who have been exposed to P3L and/or Nicorette® inhalator. Safety population = 16 subjects. It should be noted that the assessment of clinical chemistry parameters occurred only at admission and Visit 6/early termination. Consequently, all safety laboratories occurring with product use where reported as pertaining to the last exposure period, i.e. P3L 150 μg/puff period.
|
0.00%
0/16 • From the informed consent form (ICF) signature until the end of the safety follow-up period, up to 49 days (see the section "Detailed Description" for information on the study duration). The adverse events were tabulated for the safety population for: * Enrolment period (product test period, from enrolment to admission) * Nicorette® inhalator period * P3L 50 μg/puff period * P3L 80 μg/puff period * P3L 150 μg/puff period * Safety follow-up period
The safety was assessed in the safety population, consisting of all subjects who have signed the ICF, and who have been exposed to P3L and/or Nicorette® inhalator. Safety population = 16 subjects. It should be noted that the assessment of clinical chemistry parameters occurred only at admission and Visit 6/early termination. Consequently, all safety laboratories occurring with product use where reported as pertaining to the last exposure period, i.e. P3L 150 μg/puff period.
|
|
Investigations
Blood Cholesterol Increased
|
6.2%
1/16 • Number of events 1 • From the informed consent form (ICF) signature until the end of the safety follow-up period, up to 49 days (see the section "Detailed Description" for information on the study duration). The adverse events were tabulated for the safety population for: * Enrolment period (product test period, from enrolment to admission) * Nicorette® inhalator period * P3L 50 μg/puff period * P3L 80 μg/puff period * P3L 150 μg/puff period * Safety follow-up period
The safety was assessed in the safety population, consisting of all subjects who have signed the ICF, and who have been exposed to P3L and/or Nicorette® inhalator. Safety population = 16 subjects. It should be noted that the assessment of clinical chemistry parameters occurred only at admission and Visit 6/early termination. Consequently, all safety laboratories occurring with product use where reported as pertaining to the last exposure period, i.e. P3L 150 μg/puff period.
|
0.00%
0/15 • From the informed consent form (ICF) signature until the end of the safety follow-up period, up to 49 days (see the section "Detailed Description" for information on the study duration). The adverse events were tabulated for the safety population for: * Enrolment period (product test period, from enrolment to admission) * Nicorette® inhalator period * P3L 50 μg/puff period * P3L 80 μg/puff period * P3L 150 μg/puff period * Safety follow-up period
The safety was assessed in the safety population, consisting of all subjects who have signed the ICF, and who have been exposed to P3L and/or Nicorette® inhalator. Safety population = 16 subjects. It should be noted that the assessment of clinical chemistry parameters occurred only at admission and Visit 6/early termination. Consequently, all safety laboratories occurring with product use where reported as pertaining to the last exposure period, i.e. P3L 150 μg/puff period.
|
0.00%
0/15 • From the informed consent form (ICF) signature until the end of the safety follow-up period, up to 49 days (see the section "Detailed Description" for information on the study duration). The adverse events were tabulated for the safety population for: * Enrolment period (product test period, from enrolment to admission) * Nicorette® inhalator period * P3L 50 μg/puff period * P3L 80 μg/puff period * P3L 150 μg/puff period * Safety follow-up period
The safety was assessed in the safety population, consisting of all subjects who have signed the ICF, and who have been exposed to P3L and/or Nicorette® inhalator. Safety population = 16 subjects. It should be noted that the assessment of clinical chemistry parameters occurred only at admission and Visit 6/early termination. Consequently, all safety laboratories occurring with product use where reported as pertaining to the last exposure period, i.e. P3L 150 μg/puff period.
|
0.00%
0/14 • From the informed consent form (ICF) signature until the end of the safety follow-up period, up to 49 days (see the section "Detailed Description" for information on the study duration). The adverse events were tabulated for the safety population for: * Enrolment period (product test period, from enrolment to admission) * Nicorette® inhalator period * P3L 50 μg/puff period * P3L 80 μg/puff period * P3L 150 μg/puff period * Safety follow-up period
The safety was assessed in the safety population, consisting of all subjects who have signed the ICF, and who have been exposed to P3L and/or Nicorette® inhalator. Safety population = 16 subjects. It should be noted that the assessment of clinical chemistry parameters occurred only at admission and Visit 6/early termination. Consequently, all safety laboratories occurring with product use where reported as pertaining to the last exposure period, i.e. P3L 150 μg/puff period.
|
0.00%
0/14 • From the informed consent form (ICF) signature until the end of the safety follow-up period, up to 49 days (see the section "Detailed Description" for information on the study duration). The adverse events were tabulated for the safety population for: * Enrolment period (product test period, from enrolment to admission) * Nicorette® inhalator period * P3L 50 μg/puff period * P3L 80 μg/puff period * P3L 150 μg/puff period * Safety follow-up period
The safety was assessed in the safety population, consisting of all subjects who have signed the ICF, and who have been exposed to P3L and/or Nicorette® inhalator. Safety population = 16 subjects. It should be noted that the assessment of clinical chemistry parameters occurred only at admission and Visit 6/early termination. Consequently, all safety laboratories occurring with product use where reported as pertaining to the last exposure period, i.e. P3L 150 μg/puff period.
|
0.00%
0/16 • From the informed consent form (ICF) signature until the end of the safety follow-up period, up to 49 days (see the section "Detailed Description" for information on the study duration). The adverse events were tabulated for the safety population for: * Enrolment period (product test period, from enrolment to admission) * Nicorette® inhalator period * P3L 50 μg/puff period * P3L 80 μg/puff period * P3L 150 μg/puff period * Safety follow-up period
The safety was assessed in the safety population, consisting of all subjects who have signed the ICF, and who have been exposed to P3L and/or Nicorette® inhalator. Safety population = 16 subjects. It should be noted that the assessment of clinical chemistry parameters occurred only at admission and Visit 6/early termination. Consequently, all safety laboratories occurring with product use where reported as pertaining to the last exposure period, i.e. P3L 150 μg/puff period.
|
|
Investigations
Blood Creatinine Increased
|
0.00%
0/16 • From the informed consent form (ICF) signature until the end of the safety follow-up period, up to 49 days (see the section "Detailed Description" for information on the study duration). The adverse events were tabulated for the safety population for: * Enrolment period (product test period, from enrolment to admission) * Nicorette® inhalator period * P3L 50 μg/puff period * P3L 80 μg/puff period * P3L 150 μg/puff period * Safety follow-up period
The safety was assessed in the safety population, consisting of all subjects who have signed the ICF, and who have been exposed to P3L and/or Nicorette® inhalator. Safety population = 16 subjects. It should be noted that the assessment of clinical chemistry parameters occurred only at admission and Visit 6/early termination. Consequently, all safety laboratories occurring with product use where reported as pertaining to the last exposure period, i.e. P3L 150 μg/puff period.
|
0.00%
0/15 • From the informed consent form (ICF) signature until the end of the safety follow-up period, up to 49 days (see the section "Detailed Description" for information on the study duration). The adverse events were tabulated for the safety population for: * Enrolment period (product test period, from enrolment to admission) * Nicorette® inhalator period * P3L 50 μg/puff period * P3L 80 μg/puff period * P3L 150 μg/puff period * Safety follow-up period
The safety was assessed in the safety population, consisting of all subjects who have signed the ICF, and who have been exposed to P3L and/or Nicorette® inhalator. Safety population = 16 subjects. It should be noted that the assessment of clinical chemistry parameters occurred only at admission and Visit 6/early termination. Consequently, all safety laboratories occurring with product use where reported as pertaining to the last exposure period, i.e. P3L 150 μg/puff period.
|
0.00%
0/15 • From the informed consent form (ICF) signature until the end of the safety follow-up period, up to 49 days (see the section "Detailed Description" for information on the study duration). The adverse events were tabulated for the safety population for: * Enrolment period (product test period, from enrolment to admission) * Nicorette® inhalator period * P3L 50 μg/puff period * P3L 80 μg/puff period * P3L 150 μg/puff period * Safety follow-up period
The safety was assessed in the safety population, consisting of all subjects who have signed the ICF, and who have been exposed to P3L and/or Nicorette® inhalator. Safety population = 16 subjects. It should be noted that the assessment of clinical chemistry parameters occurred only at admission and Visit 6/early termination. Consequently, all safety laboratories occurring with product use where reported as pertaining to the last exposure period, i.e. P3L 150 μg/puff period.
|
0.00%
0/14 • From the informed consent form (ICF) signature until the end of the safety follow-up period, up to 49 days (see the section "Detailed Description" for information on the study duration). The adverse events were tabulated for the safety population for: * Enrolment period (product test period, from enrolment to admission) * Nicorette® inhalator period * P3L 50 μg/puff period * P3L 80 μg/puff period * P3L 150 μg/puff period * Safety follow-up period
The safety was assessed in the safety population, consisting of all subjects who have signed the ICF, and who have been exposed to P3L and/or Nicorette® inhalator. Safety population = 16 subjects. It should be noted that the assessment of clinical chemistry parameters occurred only at admission and Visit 6/early termination. Consequently, all safety laboratories occurring with product use where reported as pertaining to the last exposure period, i.e. P3L 150 μg/puff period.
|
7.1%
1/14 • Number of events 1 • From the informed consent form (ICF) signature until the end of the safety follow-up period, up to 49 days (see the section "Detailed Description" for information on the study duration). The adverse events were tabulated for the safety population for: * Enrolment period (product test period, from enrolment to admission) * Nicorette® inhalator period * P3L 50 μg/puff period * P3L 80 μg/puff period * P3L 150 μg/puff period * Safety follow-up period
The safety was assessed in the safety population, consisting of all subjects who have signed the ICF, and who have been exposed to P3L and/or Nicorette® inhalator. Safety population = 16 subjects. It should be noted that the assessment of clinical chemistry parameters occurred only at admission and Visit 6/early termination. Consequently, all safety laboratories occurring with product use where reported as pertaining to the last exposure period, i.e. P3L 150 μg/puff period.
|
0.00%
0/16 • From the informed consent form (ICF) signature until the end of the safety follow-up period, up to 49 days (see the section "Detailed Description" for information on the study duration). The adverse events were tabulated for the safety population for: * Enrolment period (product test period, from enrolment to admission) * Nicorette® inhalator period * P3L 50 μg/puff period * P3L 80 μg/puff period * P3L 150 μg/puff period * Safety follow-up period
The safety was assessed in the safety population, consisting of all subjects who have signed the ICF, and who have been exposed to P3L and/or Nicorette® inhalator. Safety population = 16 subjects. It should be noted that the assessment of clinical chemistry parameters occurred only at admission and Visit 6/early termination. Consequently, all safety laboratories occurring with product use where reported as pertaining to the last exposure period, i.e. P3L 150 μg/puff period.
|
|
Investigations
Blood Sodium Increased
|
6.2%
1/16 • Number of events 1 • From the informed consent form (ICF) signature until the end of the safety follow-up period, up to 49 days (see the section "Detailed Description" for information on the study duration). The adverse events were tabulated for the safety population for: * Enrolment period (product test period, from enrolment to admission) * Nicorette® inhalator period * P3L 50 μg/puff period * P3L 80 μg/puff period * P3L 150 μg/puff period * Safety follow-up period
The safety was assessed in the safety population, consisting of all subjects who have signed the ICF, and who have been exposed to P3L and/or Nicorette® inhalator. Safety population = 16 subjects. It should be noted that the assessment of clinical chemistry parameters occurred only at admission and Visit 6/early termination. Consequently, all safety laboratories occurring with product use where reported as pertaining to the last exposure period, i.e. P3L 150 μg/puff period.
|
0.00%
0/15 • From the informed consent form (ICF) signature until the end of the safety follow-up period, up to 49 days (see the section "Detailed Description" for information on the study duration). The adverse events were tabulated for the safety population for: * Enrolment period (product test period, from enrolment to admission) * Nicorette® inhalator period * P3L 50 μg/puff period * P3L 80 μg/puff period * P3L 150 μg/puff period * Safety follow-up period
The safety was assessed in the safety population, consisting of all subjects who have signed the ICF, and who have been exposed to P3L and/or Nicorette® inhalator. Safety population = 16 subjects. It should be noted that the assessment of clinical chemistry parameters occurred only at admission and Visit 6/early termination. Consequently, all safety laboratories occurring with product use where reported as pertaining to the last exposure period, i.e. P3L 150 μg/puff period.
|
0.00%
0/15 • From the informed consent form (ICF) signature until the end of the safety follow-up period, up to 49 days (see the section "Detailed Description" for information on the study duration). The adverse events were tabulated for the safety population for: * Enrolment period (product test period, from enrolment to admission) * Nicorette® inhalator period * P3L 50 μg/puff period * P3L 80 μg/puff period * P3L 150 μg/puff period * Safety follow-up period
The safety was assessed in the safety population, consisting of all subjects who have signed the ICF, and who have been exposed to P3L and/or Nicorette® inhalator. Safety population = 16 subjects. It should be noted that the assessment of clinical chemistry parameters occurred only at admission and Visit 6/early termination. Consequently, all safety laboratories occurring with product use where reported as pertaining to the last exposure period, i.e. P3L 150 μg/puff period.
|
0.00%
0/14 • From the informed consent form (ICF) signature until the end of the safety follow-up period, up to 49 days (see the section "Detailed Description" for information on the study duration). The adverse events were tabulated for the safety population for: * Enrolment period (product test period, from enrolment to admission) * Nicorette® inhalator period * P3L 50 μg/puff period * P3L 80 μg/puff period * P3L 150 μg/puff period * Safety follow-up period
The safety was assessed in the safety population, consisting of all subjects who have signed the ICF, and who have been exposed to P3L and/or Nicorette® inhalator. Safety population = 16 subjects. It should be noted that the assessment of clinical chemistry parameters occurred only at admission and Visit 6/early termination. Consequently, all safety laboratories occurring with product use where reported as pertaining to the last exposure period, i.e. P3L 150 μg/puff period.
|
0.00%
0/14 • From the informed consent form (ICF) signature until the end of the safety follow-up period, up to 49 days (see the section "Detailed Description" for information on the study duration). The adverse events were tabulated for the safety population for: * Enrolment period (product test period, from enrolment to admission) * Nicorette® inhalator period * P3L 50 μg/puff period * P3L 80 μg/puff period * P3L 150 μg/puff period * Safety follow-up period
The safety was assessed in the safety population, consisting of all subjects who have signed the ICF, and who have been exposed to P3L and/or Nicorette® inhalator. Safety population = 16 subjects. It should be noted that the assessment of clinical chemistry parameters occurred only at admission and Visit 6/early termination. Consequently, all safety laboratories occurring with product use where reported as pertaining to the last exposure period, i.e. P3L 150 μg/puff period.
|
0.00%
0/16 • From the informed consent form (ICF) signature until the end of the safety follow-up period, up to 49 days (see the section "Detailed Description" for information on the study duration). The adverse events were tabulated for the safety population for: * Enrolment period (product test period, from enrolment to admission) * Nicorette® inhalator period * P3L 50 μg/puff period * P3L 80 μg/puff period * P3L 150 μg/puff period * Safety follow-up period
The safety was assessed in the safety population, consisting of all subjects who have signed the ICF, and who have been exposed to P3L and/or Nicorette® inhalator. Safety population = 16 subjects. It should be noted that the assessment of clinical chemistry parameters occurred only at admission and Visit 6/early termination. Consequently, all safety laboratories occurring with product use where reported as pertaining to the last exposure period, i.e. P3L 150 μg/puff period.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/16 • From the informed consent form (ICF) signature until the end of the safety follow-up period, up to 49 days (see the section "Detailed Description" for information on the study duration). The adverse events were tabulated for the safety population for: * Enrolment period (product test period, from enrolment to admission) * Nicorette® inhalator period * P3L 50 μg/puff period * P3L 80 μg/puff period * P3L 150 μg/puff period * Safety follow-up period
The safety was assessed in the safety population, consisting of all subjects who have signed the ICF, and who have been exposed to P3L and/or Nicorette® inhalator. Safety population = 16 subjects. It should be noted that the assessment of clinical chemistry parameters occurred only at admission and Visit 6/early termination. Consequently, all safety laboratories occurring with product use where reported as pertaining to the last exposure period, i.e. P3L 150 μg/puff period.
|
6.7%
1/15 • Number of events 1 • From the informed consent form (ICF) signature until the end of the safety follow-up period, up to 49 days (see the section "Detailed Description" for information on the study duration). The adverse events were tabulated for the safety population for: * Enrolment period (product test period, from enrolment to admission) * Nicorette® inhalator period * P3L 50 μg/puff period * P3L 80 μg/puff period * P3L 150 μg/puff period * Safety follow-up period
The safety was assessed in the safety population, consisting of all subjects who have signed the ICF, and who have been exposed to P3L and/or Nicorette® inhalator. Safety population = 16 subjects. It should be noted that the assessment of clinical chemistry parameters occurred only at admission and Visit 6/early termination. Consequently, all safety laboratories occurring with product use where reported as pertaining to the last exposure period, i.e. P3L 150 μg/puff period.
|
20.0%
3/15 • Number of events 3 • From the informed consent form (ICF) signature until the end of the safety follow-up period, up to 49 days (see the section "Detailed Description" for information on the study duration). The adverse events were tabulated for the safety population for: * Enrolment period (product test period, from enrolment to admission) * Nicorette® inhalator period * P3L 50 μg/puff period * P3L 80 μg/puff period * P3L 150 μg/puff period * Safety follow-up period
The safety was assessed in the safety population, consisting of all subjects who have signed the ICF, and who have been exposed to P3L and/or Nicorette® inhalator. Safety population = 16 subjects. It should be noted that the assessment of clinical chemistry parameters occurred only at admission and Visit 6/early termination. Consequently, all safety laboratories occurring with product use where reported as pertaining to the last exposure period, i.e. P3L 150 μg/puff period.
|
21.4%
3/14 • Number of events 3 • From the informed consent form (ICF) signature until the end of the safety follow-up period, up to 49 days (see the section "Detailed Description" for information on the study duration). The adverse events were tabulated for the safety population for: * Enrolment period (product test period, from enrolment to admission) * Nicorette® inhalator period * P3L 50 μg/puff period * P3L 80 μg/puff period * P3L 150 μg/puff period * Safety follow-up period
The safety was assessed in the safety population, consisting of all subjects who have signed the ICF, and who have been exposed to P3L and/or Nicorette® inhalator. Safety population = 16 subjects. It should be noted that the assessment of clinical chemistry parameters occurred only at admission and Visit 6/early termination. Consequently, all safety laboratories occurring with product use where reported as pertaining to the last exposure period, i.e. P3L 150 μg/puff period.
|
28.6%
4/14 • Number of events 4 • From the informed consent form (ICF) signature until the end of the safety follow-up period, up to 49 days (see the section "Detailed Description" for information on the study duration). The adverse events were tabulated for the safety population for: * Enrolment period (product test period, from enrolment to admission) * Nicorette® inhalator period * P3L 50 μg/puff period * P3L 80 μg/puff period * P3L 150 μg/puff period * Safety follow-up period
The safety was assessed in the safety population, consisting of all subjects who have signed the ICF, and who have been exposed to P3L and/or Nicorette® inhalator. Safety population = 16 subjects. It should be noted that the assessment of clinical chemistry parameters occurred only at admission and Visit 6/early termination. Consequently, all safety laboratories occurring with product use where reported as pertaining to the last exposure period, i.e. P3L 150 μg/puff period.
|
0.00%
0/16 • From the informed consent form (ICF) signature until the end of the safety follow-up period, up to 49 days (see the section "Detailed Description" for information on the study duration). The adverse events were tabulated for the safety population for: * Enrolment period (product test period, from enrolment to admission) * Nicorette® inhalator period * P3L 50 μg/puff period * P3L 80 μg/puff period * P3L 150 μg/puff period * Safety follow-up period
The safety was assessed in the safety population, consisting of all subjects who have signed the ICF, and who have been exposed to P3L and/or Nicorette® inhalator. Safety population = 16 subjects. It should be noted that the assessment of clinical chemistry parameters occurred only at admission and Visit 6/early termination. Consequently, all safety laboratories occurring with product use where reported as pertaining to the last exposure period, i.e. P3L 150 μg/puff period.
|
|
Nervous system disorders
Headache
|
0.00%
0/16 • From the informed consent form (ICF) signature until the end of the safety follow-up period, up to 49 days (see the section "Detailed Description" for information on the study duration). The adverse events were tabulated for the safety population for: * Enrolment period (product test period, from enrolment to admission) * Nicorette® inhalator period * P3L 50 μg/puff period * P3L 80 μg/puff period * P3L 150 μg/puff period * Safety follow-up period
The safety was assessed in the safety population, consisting of all subjects who have signed the ICF, and who have been exposed to P3L and/or Nicorette® inhalator. Safety population = 16 subjects. It should be noted that the assessment of clinical chemistry parameters occurred only at admission and Visit 6/early termination. Consequently, all safety laboratories occurring with product use where reported as pertaining to the last exposure period, i.e. P3L 150 μg/puff period.
|
13.3%
2/15 • Number of events 2 • From the informed consent form (ICF) signature until the end of the safety follow-up period, up to 49 days (see the section "Detailed Description" for information on the study duration). The adverse events were tabulated for the safety population for: * Enrolment period (product test period, from enrolment to admission) * Nicorette® inhalator period * P3L 50 μg/puff period * P3L 80 μg/puff period * P3L 150 μg/puff period * Safety follow-up period
The safety was assessed in the safety population, consisting of all subjects who have signed the ICF, and who have been exposed to P3L and/or Nicorette® inhalator. Safety population = 16 subjects. It should be noted that the assessment of clinical chemistry parameters occurred only at admission and Visit 6/early termination. Consequently, all safety laboratories occurring with product use where reported as pertaining to the last exposure period, i.e. P3L 150 μg/puff period.
|
0.00%
0/15 • From the informed consent form (ICF) signature until the end of the safety follow-up period, up to 49 days (see the section "Detailed Description" for information on the study duration). The adverse events were tabulated for the safety population for: * Enrolment period (product test period, from enrolment to admission) * Nicorette® inhalator period * P3L 50 μg/puff period * P3L 80 μg/puff period * P3L 150 μg/puff period * Safety follow-up period
The safety was assessed in the safety population, consisting of all subjects who have signed the ICF, and who have been exposed to P3L and/or Nicorette® inhalator. Safety population = 16 subjects. It should be noted that the assessment of clinical chemistry parameters occurred only at admission and Visit 6/early termination. Consequently, all safety laboratories occurring with product use where reported as pertaining to the last exposure period, i.e. P3L 150 μg/puff period.
|
0.00%
0/14 • From the informed consent form (ICF) signature until the end of the safety follow-up period, up to 49 days (see the section "Detailed Description" for information on the study duration). The adverse events were tabulated for the safety population for: * Enrolment period (product test period, from enrolment to admission) * Nicorette® inhalator period * P3L 50 μg/puff period * P3L 80 μg/puff period * P3L 150 μg/puff period * Safety follow-up period
The safety was assessed in the safety population, consisting of all subjects who have signed the ICF, and who have been exposed to P3L and/or Nicorette® inhalator. Safety population = 16 subjects. It should be noted that the assessment of clinical chemistry parameters occurred only at admission and Visit 6/early termination. Consequently, all safety laboratories occurring with product use where reported as pertaining to the last exposure period, i.e. P3L 150 μg/puff period.
|
0.00%
0/14 • From the informed consent form (ICF) signature until the end of the safety follow-up period, up to 49 days (see the section "Detailed Description" for information on the study duration). The adverse events were tabulated for the safety population for: * Enrolment period (product test period, from enrolment to admission) * Nicorette® inhalator period * P3L 50 μg/puff period * P3L 80 μg/puff period * P3L 150 μg/puff period * Safety follow-up period
The safety was assessed in the safety population, consisting of all subjects who have signed the ICF, and who have been exposed to P3L and/or Nicorette® inhalator. Safety population = 16 subjects. It should be noted that the assessment of clinical chemistry parameters occurred only at admission and Visit 6/early termination. Consequently, all safety laboratories occurring with product use where reported as pertaining to the last exposure period, i.e. P3L 150 μg/puff period.
|
0.00%
0/16 • From the informed consent form (ICF) signature until the end of the safety follow-up period, up to 49 days (see the section "Detailed Description" for information on the study duration). The adverse events were tabulated for the safety population for: * Enrolment period (product test period, from enrolment to admission) * Nicorette® inhalator period * P3L 50 μg/puff period * P3L 80 μg/puff period * P3L 150 μg/puff period * Safety follow-up period
The safety was assessed in the safety population, consisting of all subjects who have signed the ICF, and who have been exposed to P3L and/or Nicorette® inhalator. Safety population = 16 subjects. It should be noted that the assessment of clinical chemistry parameters occurred only at admission and Visit 6/early termination. Consequently, all safety laboratories occurring with product use where reported as pertaining to the last exposure period, i.e. P3L 150 μg/puff period.
|
|
Nervous system disorders
Syncope
|
0.00%
0/16 • From the informed consent form (ICF) signature until the end of the safety follow-up period, up to 49 days (see the section "Detailed Description" for information on the study duration). The adverse events were tabulated for the safety population for: * Enrolment period (product test period, from enrolment to admission) * Nicorette® inhalator period * P3L 50 μg/puff period * P3L 80 μg/puff period * P3L 150 μg/puff period * Safety follow-up period
The safety was assessed in the safety population, consisting of all subjects who have signed the ICF, and who have been exposed to P3L and/or Nicorette® inhalator. Safety population = 16 subjects. It should be noted that the assessment of clinical chemistry parameters occurred only at admission and Visit 6/early termination. Consequently, all safety laboratories occurring with product use where reported as pertaining to the last exposure period, i.e. P3L 150 μg/puff period.
|
0.00%
0/15 • From the informed consent form (ICF) signature until the end of the safety follow-up period, up to 49 days (see the section "Detailed Description" for information on the study duration). The adverse events were tabulated for the safety population for: * Enrolment period (product test period, from enrolment to admission) * Nicorette® inhalator period * P3L 50 μg/puff period * P3L 80 μg/puff period * P3L 150 μg/puff period * Safety follow-up period
The safety was assessed in the safety population, consisting of all subjects who have signed the ICF, and who have been exposed to P3L and/or Nicorette® inhalator. Safety population = 16 subjects. It should be noted that the assessment of clinical chemistry parameters occurred only at admission and Visit 6/early termination. Consequently, all safety laboratories occurring with product use where reported as pertaining to the last exposure period, i.e. P3L 150 μg/puff period.
|
0.00%
0/15 • From the informed consent form (ICF) signature until the end of the safety follow-up period, up to 49 days (see the section "Detailed Description" for information on the study duration). The adverse events were tabulated for the safety population for: * Enrolment period (product test period, from enrolment to admission) * Nicorette® inhalator period * P3L 50 μg/puff period * P3L 80 μg/puff period * P3L 150 μg/puff period * Safety follow-up period
The safety was assessed in the safety population, consisting of all subjects who have signed the ICF, and who have been exposed to P3L and/or Nicorette® inhalator. Safety population = 16 subjects. It should be noted that the assessment of clinical chemistry parameters occurred only at admission and Visit 6/early termination. Consequently, all safety laboratories occurring with product use where reported as pertaining to the last exposure period, i.e. P3L 150 μg/puff period.
|
7.1%
1/14 • Number of events 1 • From the informed consent form (ICF) signature until the end of the safety follow-up period, up to 49 days (see the section "Detailed Description" for information on the study duration). The adverse events were tabulated for the safety population for: * Enrolment period (product test period, from enrolment to admission) * Nicorette® inhalator period * P3L 50 μg/puff period * P3L 80 μg/puff period * P3L 150 μg/puff period * Safety follow-up period
The safety was assessed in the safety population, consisting of all subjects who have signed the ICF, and who have been exposed to P3L and/or Nicorette® inhalator. Safety population = 16 subjects. It should be noted that the assessment of clinical chemistry parameters occurred only at admission and Visit 6/early termination. Consequently, all safety laboratories occurring with product use where reported as pertaining to the last exposure period, i.e. P3L 150 μg/puff period.
|
0.00%
0/14 • From the informed consent form (ICF) signature until the end of the safety follow-up period, up to 49 days (see the section "Detailed Description" for information on the study duration). The adverse events were tabulated for the safety population for: * Enrolment period (product test period, from enrolment to admission) * Nicorette® inhalator period * P3L 50 μg/puff period * P3L 80 μg/puff period * P3L 150 μg/puff period * Safety follow-up period
The safety was assessed in the safety population, consisting of all subjects who have signed the ICF, and who have been exposed to P3L and/or Nicorette® inhalator. Safety population = 16 subjects. It should be noted that the assessment of clinical chemistry parameters occurred only at admission and Visit 6/early termination. Consequently, all safety laboratories occurring with product use where reported as pertaining to the last exposure period, i.e. P3L 150 μg/puff period.
|
0.00%
0/16 • From the informed consent form (ICF) signature until the end of the safety follow-up period, up to 49 days (see the section "Detailed Description" for information on the study duration). The adverse events were tabulated for the safety population for: * Enrolment period (product test period, from enrolment to admission) * Nicorette® inhalator period * P3L 50 μg/puff period * P3L 80 μg/puff period * P3L 150 μg/puff period * Safety follow-up period
The safety was assessed in the safety population, consisting of all subjects who have signed the ICF, and who have been exposed to P3L and/or Nicorette® inhalator. Safety population = 16 subjects. It should be noted that the assessment of clinical chemistry parameters occurred only at admission and Visit 6/early termination. Consequently, all safety laboratories occurring with product use where reported as pertaining to the last exposure period, i.e. P3L 150 μg/puff period.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/16 • From the informed consent form (ICF) signature until the end of the safety follow-up period, up to 49 days (see the section "Detailed Description" for information on the study duration). The adverse events were tabulated for the safety population for: * Enrolment period (product test period, from enrolment to admission) * Nicorette® inhalator period * P3L 50 μg/puff period * P3L 80 μg/puff period * P3L 150 μg/puff period * Safety follow-up period
The safety was assessed in the safety population, consisting of all subjects who have signed the ICF, and who have been exposed to P3L and/or Nicorette® inhalator. Safety population = 16 subjects. It should be noted that the assessment of clinical chemistry parameters occurred only at admission and Visit 6/early termination. Consequently, all safety laboratories occurring with product use where reported as pertaining to the last exposure period, i.e. P3L 150 μg/puff period.
|
0.00%
0/15 • From the informed consent form (ICF) signature until the end of the safety follow-up period, up to 49 days (see the section "Detailed Description" for information on the study duration). The adverse events were tabulated for the safety population for: * Enrolment period (product test period, from enrolment to admission) * Nicorette® inhalator period * P3L 50 μg/puff period * P3L 80 μg/puff period * P3L 150 μg/puff period * Safety follow-up period
The safety was assessed in the safety population, consisting of all subjects who have signed the ICF, and who have been exposed to P3L and/or Nicorette® inhalator. Safety population = 16 subjects. It should be noted that the assessment of clinical chemistry parameters occurred only at admission and Visit 6/early termination. Consequently, all safety laboratories occurring with product use where reported as pertaining to the last exposure period, i.e. P3L 150 μg/puff period.
|
0.00%
0/15 • From the informed consent form (ICF) signature until the end of the safety follow-up period, up to 49 days (see the section "Detailed Description" for information on the study duration). The adverse events were tabulated for the safety population for: * Enrolment period (product test period, from enrolment to admission) * Nicorette® inhalator period * P3L 50 μg/puff period * P3L 80 μg/puff period * P3L 150 μg/puff period * Safety follow-up period
The safety was assessed in the safety population, consisting of all subjects who have signed the ICF, and who have been exposed to P3L and/or Nicorette® inhalator. Safety population = 16 subjects. It should be noted that the assessment of clinical chemistry parameters occurred only at admission and Visit 6/early termination. Consequently, all safety laboratories occurring with product use where reported as pertaining to the last exposure period, i.e. P3L 150 μg/puff period.
|
0.00%
0/14 • From the informed consent form (ICF) signature until the end of the safety follow-up period, up to 49 days (see the section "Detailed Description" for information on the study duration). The adverse events were tabulated for the safety population for: * Enrolment period (product test period, from enrolment to admission) * Nicorette® inhalator period * P3L 50 μg/puff period * P3L 80 μg/puff period * P3L 150 μg/puff period * Safety follow-up period
The safety was assessed in the safety population, consisting of all subjects who have signed the ICF, and who have been exposed to P3L and/or Nicorette® inhalator. Safety population = 16 subjects. It should be noted that the assessment of clinical chemistry parameters occurred only at admission and Visit 6/early termination. Consequently, all safety laboratories occurring with product use where reported as pertaining to the last exposure period, i.e. P3L 150 μg/puff period.
|
7.1%
1/14 • Number of events 1 • From the informed consent form (ICF) signature until the end of the safety follow-up period, up to 49 days (see the section "Detailed Description" for information on the study duration). The adverse events were tabulated for the safety population for: * Enrolment period (product test period, from enrolment to admission) * Nicorette® inhalator period * P3L 50 μg/puff period * P3L 80 μg/puff period * P3L 150 μg/puff period * Safety follow-up period
The safety was assessed in the safety population, consisting of all subjects who have signed the ICF, and who have been exposed to P3L and/or Nicorette® inhalator. Safety population = 16 subjects. It should be noted that the assessment of clinical chemistry parameters occurred only at admission and Visit 6/early termination. Consequently, all safety laboratories occurring with product use where reported as pertaining to the last exposure period, i.e. P3L 150 μg/puff period.
|
6.2%
1/16 • Number of events 1 • From the informed consent form (ICF) signature until the end of the safety follow-up period, up to 49 days (see the section "Detailed Description" for information on the study duration). The adverse events were tabulated for the safety population for: * Enrolment period (product test period, from enrolment to admission) * Nicorette® inhalator period * P3L 50 μg/puff period * P3L 80 μg/puff period * P3L 150 μg/puff period * Safety follow-up period
The safety was assessed in the safety population, consisting of all subjects who have signed the ICF, and who have been exposed to P3L and/or Nicorette® inhalator. Safety population = 16 subjects. It should be noted that the assessment of clinical chemistry parameters occurred only at admission and Visit 6/early termination. Consequently, all safety laboratories occurring with product use where reported as pertaining to the last exposure period, i.e. P3L 150 μg/puff period.
|
|
Skin and subcutaneous tissue disorders
Skin Disorder
|
0.00%
0/16 • From the informed consent form (ICF) signature until the end of the safety follow-up period, up to 49 days (see the section "Detailed Description" for information on the study duration). The adverse events were tabulated for the safety population for: * Enrolment period (product test period, from enrolment to admission) * Nicorette® inhalator period * P3L 50 μg/puff period * P3L 80 μg/puff period * P3L 150 μg/puff period * Safety follow-up period
The safety was assessed in the safety population, consisting of all subjects who have signed the ICF, and who have been exposed to P3L and/or Nicorette® inhalator. Safety population = 16 subjects. It should be noted that the assessment of clinical chemistry parameters occurred only at admission and Visit 6/early termination. Consequently, all safety laboratories occurring with product use where reported as pertaining to the last exposure period, i.e. P3L 150 μg/puff period.
|
6.7%
1/15 • Number of events 1 • From the informed consent form (ICF) signature until the end of the safety follow-up period, up to 49 days (see the section "Detailed Description" for information on the study duration). The adverse events were tabulated for the safety population for: * Enrolment period (product test period, from enrolment to admission) * Nicorette® inhalator period * P3L 50 μg/puff period * P3L 80 μg/puff period * P3L 150 μg/puff period * Safety follow-up period
The safety was assessed in the safety population, consisting of all subjects who have signed the ICF, and who have been exposed to P3L and/or Nicorette® inhalator. Safety population = 16 subjects. It should be noted that the assessment of clinical chemistry parameters occurred only at admission and Visit 6/early termination. Consequently, all safety laboratories occurring with product use where reported as pertaining to the last exposure period, i.e. P3L 150 μg/puff period.
|
0.00%
0/15 • From the informed consent form (ICF) signature until the end of the safety follow-up period, up to 49 days (see the section "Detailed Description" for information on the study duration). The adverse events were tabulated for the safety population for: * Enrolment period (product test period, from enrolment to admission) * Nicorette® inhalator period * P3L 50 μg/puff period * P3L 80 μg/puff period * P3L 150 μg/puff period * Safety follow-up period
The safety was assessed in the safety population, consisting of all subjects who have signed the ICF, and who have been exposed to P3L and/or Nicorette® inhalator. Safety population = 16 subjects. It should be noted that the assessment of clinical chemistry parameters occurred only at admission and Visit 6/early termination. Consequently, all safety laboratories occurring with product use where reported as pertaining to the last exposure period, i.e. P3L 150 μg/puff period.
|
0.00%
0/14 • From the informed consent form (ICF) signature until the end of the safety follow-up period, up to 49 days (see the section "Detailed Description" for information on the study duration). The adverse events were tabulated for the safety population for: * Enrolment period (product test period, from enrolment to admission) * Nicorette® inhalator period * P3L 50 μg/puff period * P3L 80 μg/puff period * P3L 150 μg/puff period * Safety follow-up period
The safety was assessed in the safety population, consisting of all subjects who have signed the ICF, and who have been exposed to P3L and/or Nicorette® inhalator. Safety population = 16 subjects. It should be noted that the assessment of clinical chemistry parameters occurred only at admission and Visit 6/early termination. Consequently, all safety laboratories occurring with product use where reported as pertaining to the last exposure period, i.e. P3L 150 μg/puff period.
|
0.00%
0/14 • From the informed consent form (ICF) signature until the end of the safety follow-up period, up to 49 days (see the section "Detailed Description" for information on the study duration). The adverse events were tabulated for the safety population for: * Enrolment period (product test period, from enrolment to admission) * Nicorette® inhalator period * P3L 50 μg/puff period * P3L 80 μg/puff period * P3L 150 μg/puff period * Safety follow-up period
The safety was assessed in the safety population, consisting of all subjects who have signed the ICF, and who have been exposed to P3L and/or Nicorette® inhalator. Safety population = 16 subjects. It should be noted that the assessment of clinical chemistry parameters occurred only at admission and Visit 6/early termination. Consequently, all safety laboratories occurring with product use where reported as pertaining to the last exposure period, i.e. P3L 150 μg/puff period.
|
0.00%
0/16 • From the informed consent form (ICF) signature until the end of the safety follow-up period, up to 49 days (see the section "Detailed Description" for information on the study duration). The adverse events were tabulated for the safety population for: * Enrolment period (product test period, from enrolment to admission) * Nicorette® inhalator period * P3L 50 μg/puff period * P3L 80 μg/puff period * P3L 150 μg/puff period * Safety follow-up period
The safety was assessed in the safety population, consisting of all subjects who have signed the ICF, and who have been exposed to P3L and/or Nicorette® inhalator. Safety population = 16 subjects. It should be noted that the assessment of clinical chemistry parameters occurred only at admission and Visit 6/early termination. Consequently, all safety laboratories occurring with product use where reported as pertaining to the last exposure period, i.e. P3L 150 μg/puff period.
|
|
Skin and subcutaneous tissue disorders
Skin Irritation
|
0.00%
0/16 • From the informed consent form (ICF) signature until the end of the safety follow-up period, up to 49 days (see the section "Detailed Description" for information on the study duration). The adverse events were tabulated for the safety population for: * Enrolment period (product test period, from enrolment to admission) * Nicorette® inhalator period * P3L 50 μg/puff period * P3L 80 μg/puff period * P3L 150 μg/puff period * Safety follow-up period
The safety was assessed in the safety population, consisting of all subjects who have signed the ICF, and who have been exposed to P3L and/or Nicorette® inhalator. Safety population = 16 subjects. It should be noted that the assessment of clinical chemistry parameters occurred only at admission and Visit 6/early termination. Consequently, all safety laboratories occurring with product use where reported as pertaining to the last exposure period, i.e. P3L 150 μg/puff period.
|
0.00%
0/15 • From the informed consent form (ICF) signature until the end of the safety follow-up period, up to 49 days (see the section "Detailed Description" for information on the study duration). The adverse events were tabulated for the safety population for: * Enrolment period (product test period, from enrolment to admission) * Nicorette® inhalator period * P3L 50 μg/puff period * P3L 80 μg/puff period * P3L 150 μg/puff period * Safety follow-up period
The safety was assessed in the safety population, consisting of all subjects who have signed the ICF, and who have been exposed to P3L and/or Nicorette® inhalator. Safety population = 16 subjects. It should be noted that the assessment of clinical chemistry parameters occurred only at admission and Visit 6/early termination. Consequently, all safety laboratories occurring with product use where reported as pertaining to the last exposure period, i.e. P3L 150 μg/puff period.
|
6.7%
1/15 • Number of events 1 • From the informed consent form (ICF) signature until the end of the safety follow-up period, up to 49 days (see the section "Detailed Description" for information on the study duration). The adverse events were tabulated for the safety population for: * Enrolment period (product test period, from enrolment to admission) * Nicorette® inhalator period * P3L 50 μg/puff period * P3L 80 μg/puff period * P3L 150 μg/puff period * Safety follow-up period
The safety was assessed in the safety population, consisting of all subjects who have signed the ICF, and who have been exposed to P3L and/or Nicorette® inhalator. Safety population = 16 subjects. It should be noted that the assessment of clinical chemistry parameters occurred only at admission and Visit 6/early termination. Consequently, all safety laboratories occurring with product use where reported as pertaining to the last exposure period, i.e. P3L 150 μg/puff period.
|
0.00%
0/14 • From the informed consent form (ICF) signature until the end of the safety follow-up period, up to 49 days (see the section "Detailed Description" for information on the study duration). The adverse events were tabulated for the safety population for: * Enrolment period (product test period, from enrolment to admission) * Nicorette® inhalator period * P3L 50 μg/puff period * P3L 80 μg/puff period * P3L 150 μg/puff period * Safety follow-up period
The safety was assessed in the safety population, consisting of all subjects who have signed the ICF, and who have been exposed to P3L and/or Nicorette® inhalator. Safety population = 16 subjects. It should be noted that the assessment of clinical chemistry parameters occurred only at admission and Visit 6/early termination. Consequently, all safety laboratories occurring with product use where reported as pertaining to the last exposure period, i.e. P3L 150 μg/puff period.
|
0.00%
0/14 • From the informed consent form (ICF) signature until the end of the safety follow-up period, up to 49 days (see the section "Detailed Description" for information on the study duration). The adverse events were tabulated for the safety population for: * Enrolment period (product test period, from enrolment to admission) * Nicorette® inhalator period * P3L 50 μg/puff period * P3L 80 μg/puff period * P3L 150 μg/puff period * Safety follow-up period
The safety was assessed in the safety population, consisting of all subjects who have signed the ICF, and who have been exposed to P3L and/or Nicorette® inhalator. Safety population = 16 subjects. It should be noted that the assessment of clinical chemistry parameters occurred only at admission and Visit 6/early termination. Consequently, all safety laboratories occurring with product use where reported as pertaining to the last exposure period, i.e. P3L 150 μg/puff period.
|
0.00%
0/16 • From the informed consent form (ICF) signature until the end of the safety follow-up period, up to 49 days (see the section "Detailed Description" for information on the study duration). The adverse events were tabulated for the safety population for: * Enrolment period (product test period, from enrolment to admission) * Nicorette® inhalator period * P3L 50 μg/puff period * P3L 80 μg/puff period * P3L 150 μg/puff period * Safety follow-up period
The safety was assessed in the safety population, consisting of all subjects who have signed the ICF, and who have been exposed to P3L and/or Nicorette® inhalator. Safety population = 16 subjects. It should be noted that the assessment of clinical chemistry parameters occurred only at admission and Visit 6/early termination. Consequently, all safety laboratories occurring with product use where reported as pertaining to the last exposure period, i.e. P3L 150 μg/puff period.
|
|
Vascular disorders
Hot Flush
|
0.00%
0/16 • From the informed consent form (ICF) signature until the end of the safety follow-up period, up to 49 days (see the section "Detailed Description" for information on the study duration). The adverse events were tabulated for the safety population for: * Enrolment period (product test period, from enrolment to admission) * Nicorette® inhalator period * P3L 50 μg/puff period * P3L 80 μg/puff period * P3L 150 μg/puff period * Safety follow-up period
The safety was assessed in the safety population, consisting of all subjects who have signed the ICF, and who have been exposed to P3L and/or Nicorette® inhalator. Safety population = 16 subjects. It should be noted that the assessment of clinical chemistry parameters occurred only at admission and Visit 6/early termination. Consequently, all safety laboratories occurring with product use where reported as pertaining to the last exposure period, i.e. P3L 150 μg/puff period.
|
0.00%
0/15 • From the informed consent form (ICF) signature until the end of the safety follow-up period, up to 49 days (see the section "Detailed Description" for information on the study duration). The adverse events were tabulated for the safety population for: * Enrolment period (product test period, from enrolment to admission) * Nicorette® inhalator period * P3L 50 μg/puff period * P3L 80 μg/puff period * P3L 150 μg/puff period * Safety follow-up period
The safety was assessed in the safety population, consisting of all subjects who have signed the ICF, and who have been exposed to P3L and/or Nicorette® inhalator. Safety population = 16 subjects. It should be noted that the assessment of clinical chemistry parameters occurred only at admission and Visit 6/early termination. Consequently, all safety laboratories occurring with product use where reported as pertaining to the last exposure period, i.e. P3L 150 μg/puff period.
|
0.00%
0/15 • From the informed consent form (ICF) signature until the end of the safety follow-up period, up to 49 days (see the section "Detailed Description" for information on the study duration). The adverse events were tabulated for the safety population for: * Enrolment period (product test period, from enrolment to admission) * Nicorette® inhalator period * P3L 50 μg/puff period * P3L 80 μg/puff period * P3L 150 μg/puff period * Safety follow-up period
The safety was assessed in the safety population, consisting of all subjects who have signed the ICF, and who have been exposed to P3L and/or Nicorette® inhalator. Safety population = 16 subjects. It should be noted that the assessment of clinical chemistry parameters occurred only at admission and Visit 6/early termination. Consequently, all safety laboratories occurring with product use where reported as pertaining to the last exposure period, i.e. P3L 150 μg/puff period.
|
7.1%
1/14 • Number of events 1 • From the informed consent form (ICF) signature until the end of the safety follow-up period, up to 49 days (see the section "Detailed Description" for information on the study duration). The adverse events were tabulated for the safety population for: * Enrolment period (product test period, from enrolment to admission) * Nicorette® inhalator period * P3L 50 μg/puff period * P3L 80 μg/puff period * P3L 150 μg/puff period * Safety follow-up period
The safety was assessed in the safety population, consisting of all subjects who have signed the ICF, and who have been exposed to P3L and/or Nicorette® inhalator. Safety population = 16 subjects. It should be noted that the assessment of clinical chemistry parameters occurred only at admission and Visit 6/early termination. Consequently, all safety laboratories occurring with product use where reported as pertaining to the last exposure period, i.e. P3L 150 μg/puff period.
|
7.1%
1/14 • Number of events 1 • From the informed consent form (ICF) signature until the end of the safety follow-up period, up to 49 days (see the section "Detailed Description" for information on the study duration). The adverse events were tabulated for the safety population for: * Enrolment period (product test period, from enrolment to admission) * Nicorette® inhalator period * P3L 50 μg/puff period * P3L 80 μg/puff period * P3L 150 μg/puff period * Safety follow-up period
The safety was assessed in the safety population, consisting of all subjects who have signed the ICF, and who have been exposed to P3L and/or Nicorette® inhalator. Safety population = 16 subjects. It should be noted that the assessment of clinical chemistry parameters occurred only at admission and Visit 6/early termination. Consequently, all safety laboratories occurring with product use where reported as pertaining to the last exposure period, i.e. P3L 150 μg/puff period.
|
0.00%
0/16 • From the informed consent form (ICF) signature until the end of the safety follow-up period, up to 49 days (see the section "Detailed Description" for information on the study duration). The adverse events were tabulated for the safety population for: * Enrolment period (product test period, from enrolment to admission) * Nicorette® inhalator period * P3L 50 μg/puff period * P3L 80 μg/puff period * P3L 150 μg/puff period * Safety follow-up period
The safety was assessed in the safety population, consisting of all subjects who have signed the ICF, and who have been exposed to P3L and/or Nicorette® inhalator. Safety population = 16 subjects. It should be noted that the assessment of clinical chemistry parameters occurred only at admission and Visit 6/early termination. Consequently, all safety laboratories occurring with product use where reported as pertaining to the last exposure period, i.e. P3L 150 μg/puff period.
|
|
Infections and infestations
Pharyngitis
|
6.2%
1/16 • Number of events 1 • From the informed consent form (ICF) signature until the end of the safety follow-up period, up to 49 days (see the section "Detailed Description" for information on the study duration). The adverse events were tabulated for the safety population for: * Enrolment period (product test period, from enrolment to admission) * Nicorette® inhalator period * P3L 50 μg/puff period * P3L 80 μg/puff period * P3L 150 μg/puff period * Safety follow-up period
The safety was assessed in the safety population, consisting of all subjects who have signed the ICF, and who have been exposed to P3L and/or Nicorette® inhalator. Safety population = 16 subjects. It should be noted that the assessment of clinical chemistry parameters occurred only at admission and Visit 6/early termination. Consequently, all safety laboratories occurring with product use where reported as pertaining to the last exposure period, i.e. P3L 150 μg/puff period.
|
0.00%
0/15 • From the informed consent form (ICF) signature until the end of the safety follow-up period, up to 49 days (see the section "Detailed Description" for information on the study duration). The adverse events were tabulated for the safety population for: * Enrolment period (product test period, from enrolment to admission) * Nicorette® inhalator period * P3L 50 μg/puff period * P3L 80 μg/puff period * P3L 150 μg/puff period * Safety follow-up period
The safety was assessed in the safety population, consisting of all subjects who have signed the ICF, and who have been exposed to P3L and/or Nicorette® inhalator. Safety population = 16 subjects. It should be noted that the assessment of clinical chemistry parameters occurred only at admission and Visit 6/early termination. Consequently, all safety laboratories occurring with product use where reported as pertaining to the last exposure period, i.e. P3L 150 μg/puff period.
|
0.00%
0/15 • From the informed consent form (ICF) signature until the end of the safety follow-up period, up to 49 days (see the section "Detailed Description" for information on the study duration). The adverse events were tabulated for the safety population for: * Enrolment period (product test period, from enrolment to admission) * Nicorette® inhalator period * P3L 50 μg/puff period * P3L 80 μg/puff period * P3L 150 μg/puff period * Safety follow-up period
The safety was assessed in the safety population, consisting of all subjects who have signed the ICF, and who have been exposed to P3L and/or Nicorette® inhalator. Safety population = 16 subjects. It should be noted that the assessment of clinical chemistry parameters occurred only at admission and Visit 6/early termination. Consequently, all safety laboratories occurring with product use where reported as pertaining to the last exposure period, i.e. P3L 150 μg/puff period.
|
0.00%
0/14 • From the informed consent form (ICF) signature until the end of the safety follow-up period, up to 49 days (see the section "Detailed Description" for information on the study duration). The adverse events were tabulated for the safety population for: * Enrolment period (product test period, from enrolment to admission) * Nicorette® inhalator period * P3L 50 μg/puff period * P3L 80 μg/puff period * P3L 150 μg/puff period * Safety follow-up period
The safety was assessed in the safety population, consisting of all subjects who have signed the ICF, and who have been exposed to P3L and/or Nicorette® inhalator. Safety population = 16 subjects. It should be noted that the assessment of clinical chemistry parameters occurred only at admission and Visit 6/early termination. Consequently, all safety laboratories occurring with product use where reported as pertaining to the last exposure period, i.e. P3L 150 μg/puff period.
|
0.00%
0/14 • From the informed consent form (ICF) signature until the end of the safety follow-up period, up to 49 days (see the section "Detailed Description" for information on the study duration). The adverse events were tabulated for the safety population for: * Enrolment period (product test period, from enrolment to admission) * Nicorette® inhalator period * P3L 50 μg/puff period * P3L 80 μg/puff period * P3L 150 μg/puff period * Safety follow-up period
The safety was assessed in the safety population, consisting of all subjects who have signed the ICF, and who have been exposed to P3L and/or Nicorette® inhalator. Safety population = 16 subjects. It should be noted that the assessment of clinical chemistry parameters occurred only at admission and Visit 6/early termination. Consequently, all safety laboratories occurring with product use where reported as pertaining to the last exposure period, i.e. P3L 150 μg/puff period.
|
0.00%
0/16 • From the informed consent form (ICF) signature until the end of the safety follow-up period, up to 49 days (see the section "Detailed Description" for information on the study duration). The adverse events were tabulated for the safety population for: * Enrolment period (product test period, from enrolment to admission) * Nicorette® inhalator period * P3L 50 μg/puff period * P3L 80 μg/puff period * P3L 150 μg/puff period * Safety follow-up period
The safety was assessed in the safety population, consisting of all subjects who have signed the ICF, and who have been exposed to P3L and/or Nicorette® inhalator. Safety population = 16 subjects. It should be noted that the assessment of clinical chemistry parameters occurred only at admission and Visit 6/early termination. Consequently, all safety laboratories occurring with product use where reported as pertaining to the last exposure period, i.e. P3L 150 μg/puff period.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee We confirm we have the contractual provisions in place which specify that in no event will the study site be allowed to disclose to any third party (or publicly release) any information obtained through the study without the CRO's prior written consent which in turn cannot provide such consent without Sponsor's approval unless such publication is made to satisfy regulatory requirements. The Intellectual Property rights and research results from the present study belong to the Sponsor.
- Publication restrictions are in place
Restriction type: OTHER