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This is a single-center, open-label, randomized, crossover study to evaluate the pharmacokinetic (PK) profiles of four P3P variants (differing in nicotine aerosol particle size, nicotine concentration and in the absence or presence of a flavoring system), following a fixed puffing regimen and an ad libitum use period. In addition, pharmacodynamic (PD) effects (subjective effects and related behavioral assessments), as well as human puffing topography, will be evaluated, to provide further insights on product safety, acceptance, and use.
The goal of the proposed study is to evaluate the pharmacokinetic profiles of four P3P variants. Variants with two different nicotine contents (1 mg/product and 2 mg/product), two different nicotine aersol particle sizes and presence/absence of a flavoring system will be tested to identify which one would yield plasma nicotine concentrations as close as possible to those achieved after smoking a single cigarette. All of the subjects will initially use the lowest nicotine content product (P3P 3). Subject will continue the study using the three remaining products (P3P 1, P3P 2 and P3P 4) containing 2 mg nicotine/product in a randomly assigned sequence.
Two product use regimens: fixed puffing and ad libitum use will be applied to provide insight into nicotine absorption. The fixed puffing regimen with consistent use conditions across subjects will be applied in order to minimize variability. The 1 hour ad libitum use period will provide information on nicotine PK and product acceptance when subjects use the P3P according to their own puffing behavior which is closer to a real-world setting.
Safety and tolerability will also be assessed throughout the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Product Sequence 1 | Active Comparator | Subjects will be exposed to P3P 3 on day 1 of the study, then randomized to follow a sequence of product exposure comprised of: P3P 2 on Day 2; P3P 4 on Day 3; P3P 1 on Day 4 |
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| Product Sequence 2 | Active Comparator | Subjects will be exposed to P3P 3 on day 1 of the study, then randomized to follow a sequence of product exposure comprised of: P3P 4 on Day 2; P3P 1 on Day 3; P3P 2 on Day 4 |
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| Product Sequence 3 | Active Comparator | Subjects will be exposed to P3P 3 on day 1 of the study, then randomized to follow a sequence of product exposure comprised of: P3P 1 on Day 2; P3P 2 on Day 3; P3P 4 on Day 4 |
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| Product Sequence 4 | Active Comparator | Subjects will be exposed to P3P 3 on day 1 of the study, then randomized to follow a sequence of product exposure comprised of: P3P 1 on Day 2; P3P 4 on Day 3; P3P 2 on Day 4 |
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| Product Sequence 5 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| P3P 1 | Other | 2 mg of nicotine; no flavor; nicotine powder particle size of 2.25 ± 0.2 μm |
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| Measure | Description | Time Frame |
|---|---|---|
| Plasma Nicotine Concentration-time Profile | To measure the plasma nicotine concentration-time profile of four P3P variants from the fixed puffing regimen, following correction of baseline nicotine levels. | Derived from multiple blood sampling (measured at 2 mins, 4 mins, 7 mins, 10 mins, 15 mins, 30 mins, 1 hour, 2 hours, and 4 hours post-product use) on Days 1, 2, 3 and 4 |
| Maximum Plasma Concentration [Cmax] | To measure the maximum nicotine plasma concentration [Cmax] of four P3P variants from the fixed puffing regimen, following correction of baseline nicotine levels. | Derived from multiple blood sampling (measured at 2 mins, 4 mins, 7 mins, 10 mins, 15 mins, 30 mins, 1 hour, 2 hours, and 4 hours post-product use) on Days 1, 2, 3 and 4 |
| Time to the Maximum Nicotine Concentration [Tmax] | To measure the time to maximum nicotine concentration [Tmax] of four P3P variants from the fixed puffing regimen, following correction of baseline nicotine levels. | Derived from multiple blood sampling (measured at 2 mins, 4 mins, 7 mins, 10 mins, 15 mins, 30 mins, 1 hour, 2 hours, and 4 hours post-product use) on Days 1, 2, 3 and 4 |
| Area Under the Concentration-time Curve From Start of Product Use (T0 Fix) to 4 Hours [AUCfix (0-4h)] | To measure the area under the plasma concentration-time curve of four P3P variants from the fixed puffing regimen, following correction of baseline nicotine levels. | Derived from multiple blood sampling (measured at 2 mins, 4 mins, 7 mins, 10 mins, 15 mins, 30 mins, 1 hour, 2 hours, and 4 hours post-product use) on Days 1, 2, 3 and 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma Nicotine Concentration-time Profile | To measure the plasma nicotine concentration-time profile of four P3P variants from the ad libitum use period, following correction of baseline nicotine levels. | Derived from multiple blood sampling (measured at 10 mins, 20 mins, 30 mins, 40 mins, 1 hour, 2 hours, and 4 hours during and post-ad libitum use) on Days 1, 2, 3 and 4 |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christelle Haziza, PhD | Philip Morris Products S.A. | Study Chair |
| Milko Radicioni, MD | CROSS Research, Arzo, Ticino, Switzerland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CROSS Research | Arzo | Canton Ticino | 6864 | Switzerland |
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On Day 1, 19 subjects were enrolled and exposed to "P3P 3" before randomization.
One enrolled subject withdrew after P3P 3 use before randomization. 18 subjects were randomized.
40 subjects were screened for eligibility. 21 subjects were screen failures (10 reserve subjects were not enrolled, 9 subjects did not meet eligibility criteria, and 2 subjects withdrew.)
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| ID | Title | Description |
|---|---|---|
| FG000 | Product Sequence 1 | Subjects will follow a sequence of product exposure comprised of: P3P 2 on Day 2; P3P 4 on Day 3; P3P 1 on Day 4 |
| FG001 | Product Sequence 2 | Subjects will be follow a sequence of product exposure comprised of: P3P 4 on Day 2; P3P 1 on Day 3; P3P 2 on Day 4 |
| FG002 | Product Sequence 3 | Subjects will follow a sequence of product exposure comprised of: P3P 1 on Day 2; P3P 2 on Day 3; P3P 4 on Day 4 |
| FG003 | Product Sequence 4 | Subjects will follow a sequence of product exposure comprised of: P3P 1 on Day 2; P3P 4 on Day 3; P3P 2 on Day 4 |
| FG004 | Product Sequence 5 | Subjects will follow a sequence of product exposure comprised of: P3P 2 on Day 2; P3P 1 on Day 3; P3P 4 on Day 4 |
| FG005 | Product Sequence 6 | Subjects will follow a sequence of product exposure comprised of: P3P 4 on Day 2; P3P 2 on Day 3; P3P 1 on Day 4 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Day 2 |
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| Day 3 |
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| Day 4 |
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| ID | Title | Description |
|---|---|---|
| BG000 | Safety Population | The safety population comprised all enrolled subjects who were exposed to P3P during the study. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Plasma Nicotine Concentration-time Profile | To measure the plasma nicotine concentration-time profile of four P3P variants from the fixed puffing regimen, following correction of baseline nicotine levels. | Baseline correction of nicotine concentrations could be performed for 16 out of the 18 randomized subjects. | Posted | Geometric Mean | 95% Confidence Interval | ng/mL | Derived from multiple blood sampling (measured at 2 mins, 4 mins, 7 mins, 10 mins, 15 mins, 30 mins, 1 hour, 2 hours, and 4 hours post-product use) on Days 1, 2, 3 and 4 |
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Adverse events were collected from the signature of the ICF by each subject until the end of the safety follow-up period, for a duration of up to 34 days for each subject.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Safety Population (P3P 1) | Comprising enrolled subjects who were exposed to P3P 1 during the study. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Christelle Haziza, Director Health Science and Biostatistics | Philip Morris Products S.A. | +41 58 242 11 11 | ClinicalTrials.PMI@pmi.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 24, 2017 | Apr 25, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 30, 2018 | Apr 25, 2019 | SAP_001.pdf |
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A single-center, open-label, randomized, crossover study.
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Sponsor staff, Investigator, the subjects and the investigational site will be blinded to the randomization sequences until they are assigned. Subjects will not be informed of the complete sequence to which they have been assigned.
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| Active Comparator |
Subjects will be exposed to P3P 3 on day 1 of the study, then randomized to follow a sequence of product exposure comprised of: P3P 2 on Day 2; P3P 1 on Day 3; P3P 4 on Day 4 |
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| Product Sequence 6 | Active Comparator | Subjects will be exposed to P3P 3 on day 1 of the study, then randomized to follow a sequence of product exposure comprised of: P3P 4 on Day 2; P3P 2 on Day 3; P3P 1 on Day 4 |
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| P3P 2 | Other | 2 mg of nicotine; flavor; nicotine powder particle size of 2.25 ± 0.2 μm |
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| P3P 3 | Other | 1 mg of nicotine; flavor; nicotine powder particle size of 2.25 ± 0.2 μm |
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| P3P 4 | Other | 2 mg of nicotine; flavor; nicotine powder particle size of 1.8 ± 0.2 μm |
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| Peak Plasma Nicotine Concentration [Cpeak] | To measure the Peak plasma nicotine concentration [Cpeak] of four P3P variants from the ad libitum use period, following correction of baseline nicotine levels. | Derived from multiple blood sampling (measured at 10 mins, 20 mins, 30 mins, 40 mins, 1 hour, 2 hours, and 4 hours during and post-ad libitum use) on Days 1, 2, 3 and 4 |
| Time to Peak Plasma Nicotine Concentration [Tpeak] | To measure the time to peak plasma nicotine concentration [Tpeak] of four P3P variants from the ad libitum use period, following correction of baseline nicotine levels. | Derived from multiple blood sampling (measured at 10 mins, 20 mins, 30 mins, 40 mins, 1 hour, 2 hours, and 4 hours during and post-ad libitum use) on Days 1, 2, 3 and 4 |
| Trough Plasma Nicotine Concentration [Ctrough] | To measure the trough plasma nicotine concentration [Ctrough] of four P3P variants from the ad libitum use period, following correction of baseline nicotine levels. | Derived from multiple blood sampling (measured at 10 mins, 20 mins, 30 mins, 40 mins, 1 hour, 2 hours, and 4 hours during and post-ad libitum use) on Days 1, 2, 3 and 4 |
| Average of Plasma Nicotine Concentration From T0 ad Lib to 1 Hour [Caverage] | To measure the average of plasma nicotine concentration [Caverage], of four P3P variants from the ad libitum use period, following correction of baseline nicotine levels | Derived from multiple blood sampling (measured at 10 mins, 20 mins, 30 mins, 40 mins, 1 hour during ad libitum use) on Days 1, 2, 3 and 4 |
| Area Under the Concentration-time Curve From Start of Product Use (T0 ad Lib) to 4 Hours [AUCad Lib (0-4h)] | To measure the area under the plasma concentration-time curve of four P3P variants from the ad libitum use period, following correction of baseline nicotine levels. | Derived from multiple blood sampling (measured at 10 mins, 20 mins, 30 mins, 40 mins, 1 hour, 2 hours, and 4 hours during and post-ad libitum use) on Days 1, 2, 3 and 4 |
| AUC of Craving for a Cigarette During and After the Fixed Puffing Regimen | Measured on a Visual Analogue Scale (VAS) of 0 (no craving) to 100 (strong craving). | During and up to 4 hours post-product use on days 1, 2, 3 and 4 |
| AUC Craving for a Cigarette During and After the ad Libitum Use Period | Measured on a Visual Analogue Scale (VAS) of 0 (no craving) to 100 (strong craving). | During and up to 4 hours post-product use on days 1, 2, 3 and 4 |
| Product Evaluation | Measured with an adapted version of the modified Cigarette Evaluation Questionnaire (adapted mCEQ) following the ad libitum use period. Assessed on a 7-point scale, ranging from 1 (not at all) to 7 (extremely). | Within 60 minutes after the ad libitum use session on days 1, 2, 3 and 4 |
| Sensory Parameters | Measured with a Sensory Questionnaire (SQ) following the ad libitum use period. Response to each question is assessed on a 7-point scale, ranging from 1 (not at all) to 7 (extremely). | Within 60 minutes after the ad libitum use session on days 1, 2, 3 and 4 |
| Human Puffing Topography (HPT) Parameters (Puff Volume) of Four P3P Variants During the Fixed Puffing Regimen Period. | Descriptive statistics of total puff volume and average puff volume, of four P3P variants, during the fixed puffing regimen period. | During fixed puffing product use on days 1, 2, 3 and 4 |
| Human Puffing Topography (HPT) Parameters (Puff Volume) of Four P3P Variants During the ad Libitum Use Period. | Descriptive statistics of total puff volume and average puff volume, of four P3P variants, during the ad libitum use period. | During ad libitum product use on days 1, 2, 3 and 4 |
| Amount of Powder Aerosolized From P3P From the Fixed Puffing Regimen. | Descriptive statistics of P3P weight before use, and after use, for the fixed puffing regimen. | Before and after fixed puffing product use on days 1, 2, 3 and 4 |
| Amount of Powder Aerosolized From P3P From the ad Libitum Use Period (Per Product Used). | P3P weight before use, and after use, to determine the amount of powder aerosolized from P3P during Ad Libitum use (per product used). | Before and after ad libitum product use on days 1, 2, 3 and 4 |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Body weight (kg) | Mean | Standard Deviation | kilograms |
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| Height (cm) | Mean | Standard Deviation | centimetres |
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| BMI (kg/m^2) | Mean | Standard Deviation | kg/m^2 |
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2 mg of nicotine; flavor; nicotine powder particle size of 2.25 ± 0.2 μm
| OG002 | P3P 3 | 1 mg of nicotine; flavor; nicotine powder particle size of 2.25 ± 0.2 μm |
| OG003 | P3P 4 | 2 mg of nicotine; flavor; nicotine powder particle size of 1.8 ± 0.2 μm |
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| Primary | Maximum Plasma Concentration [Cmax] | To measure the maximum nicotine plasma concentration [Cmax] of four P3P variants from the fixed puffing regimen, following correction of baseline nicotine levels. | Baseline correction of nicotine concentrations could be performed for 16 out of the 18 randomized subjects | Posted | Geometric Least Squares Mean | 95% Confidence Interval | ng/mL | Derived from multiple blood sampling (measured at 2 mins, 4 mins, 7 mins, 10 mins, 15 mins, 30 mins, 1 hour, 2 hours, and 4 hours post-product use) on Days 1, 2, 3 and 4 |
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| Primary | Time to the Maximum Nicotine Concentration [Tmax] | To measure the time to maximum nicotine concentration [Tmax] of four P3P variants from the fixed puffing regimen, following correction of baseline nicotine levels. | Baseline correction of nicotine concentrations could be performed for 16 out of the 18 randomized subjects. | Posted | Median | Full Range | minutes | Derived from multiple blood sampling (measured at 2 mins, 4 mins, 7 mins, 10 mins, 15 mins, 30 mins, 1 hour, 2 hours, and 4 hours post-product use) on Days 1, 2, 3 and 4 |
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| Primary | Area Under the Concentration-time Curve From Start of Product Use (T0 Fix) to 4 Hours [AUCfix (0-4h)] | To measure the area under the plasma concentration-time curve of four P3P variants from the fixed puffing regimen, following correction of baseline nicotine levels. | Baseline correction of nicotine concentrations could be performed for 16 out of the 18 randomized subjects. | Posted | Geometric Least Squares Mean | 95% Confidence Interval | ng/mL*h | Derived from multiple blood sampling (measured at 2 mins, 4 mins, 7 mins, 10 mins, 15 mins, 30 mins, 1 hour, 2 hours, and 4 hours post-product use) on Days 1, 2, 3 and 4 |
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| Secondary | Plasma Nicotine Concentration-time Profile | To measure the plasma nicotine concentration-time profile of four P3P variants from the ad libitum use period, following correction of baseline nicotine levels. | Baseline correction of nicotine concentrations could be performed for 16 out of the 18 randomized subjects. | Posted | Geometric Mean | 95% Confidence Interval | ng/mL | Derived from multiple blood sampling (measured at 10 mins, 20 mins, 30 mins, 40 mins, 1 hour, 2 hours, and 4 hours during and post-ad libitum use) on Days 1, 2, 3 and 4 |
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| Secondary | Peak Plasma Nicotine Concentration [Cpeak] | To measure the Peak plasma nicotine concentration [Cpeak] of four P3P variants from the ad libitum use period, following correction of baseline nicotine levels. | Baseline correction of nicotine concentrations could be performed for 16 out of the 18 randomized subjects. | Posted | Geometric Least Squares Mean | 95% Confidence Interval | ng/mL | Derived from multiple blood sampling (measured at 10 mins, 20 mins, 30 mins, 40 mins, 1 hour, 2 hours, and 4 hours during and post-ad libitum use) on Days 1, 2, 3 and 4 |
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| Secondary | Time to Peak Plasma Nicotine Concentration [Tpeak] | To measure the time to peak plasma nicotine concentration [Tpeak] of four P3P variants from the ad libitum use period, following correction of baseline nicotine levels. | Baseline correction of nicotine concentrations could be performed for 16 out of the 18 randomized subjects. | Posted | Mean | Standard Deviation | minutes | Derived from multiple blood sampling (measured at 10 mins, 20 mins, 30 mins, 40 mins, 1 hour, 2 hours, and 4 hours during and post-ad libitum use) on Days 1, 2, 3 and 4 |
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| Secondary | Trough Plasma Nicotine Concentration [Ctrough] | To measure the trough plasma nicotine concentration [Ctrough] of four P3P variants from the ad libitum use period, following correction of baseline nicotine levels. | Baseline correction of nicotine concentrations could be performed for 16 out of the 18 randomized subjects. | Posted | Geometric Least Squares Mean | 95% Confidence Interval | ng/mL | Derived from multiple blood sampling (measured at 10 mins, 20 mins, 30 mins, 40 mins, 1 hour, 2 hours, and 4 hours during and post-ad libitum use) on Days 1, 2, 3 and 4 |
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| Secondary | Average of Plasma Nicotine Concentration From T0 ad Lib to 1 Hour [Caverage] | To measure the average of plasma nicotine concentration [Caverage], of four P3P variants from the ad libitum use period, following correction of baseline nicotine levels | Baseline correction of nicotine concentrations could be performed for 16 out of the 18 randomized subjects. | Posted | Geometric Least Squares Mean | 95% Confidence Interval | ng/mL | Derived from multiple blood sampling (measured at 10 mins, 20 mins, 30 mins, 40 mins, 1 hour during ad libitum use) on Days 1, 2, 3 and 4 |
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| Secondary | Area Under the Concentration-time Curve From Start of Product Use (T0 ad Lib) to 4 Hours [AUCad Lib (0-4h)] | To measure the area under the plasma concentration-time curve of four P3P variants from the ad libitum use period, following correction of baseline nicotine levels. | Baseline correction of nicotine concentrations could be performed for 16 out of the 18 randomized subjects. | Posted | Geometric Least Squares Mean | 95% Confidence Interval | ng/mL*h | Derived from multiple blood sampling (measured at 10 mins, 20 mins, 30 mins, 40 mins, 1 hour, 2 hours, and 4 hours during and post-ad libitum use) on Days 1, 2, 3 and 4 |
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| Secondary | AUC of Craving for a Cigarette During and After the Fixed Puffing Regimen | Measured on a Visual Analogue Scale (VAS) of 0 (no craving) to 100 (strong craving). | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale (millimetres)*h | During and up to 4 hours post-product use on days 1, 2, 3 and 4 |
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| Secondary | AUC Craving for a Cigarette During and After the ad Libitum Use Period | Measured on a Visual Analogue Scale (VAS) of 0 (no craving) to 100 (strong craving). | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale (millimetres)*h | During and up to 4 hours post-product use on days 1, 2, 3 and 4 |
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| Secondary | Product Evaluation | Measured with an adapted version of the modified Cigarette Evaluation Questionnaire (adapted mCEQ) following the ad libitum use period. Assessed on a 7-point scale, ranging from 1 (not at all) to 7 (extremely). | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Within 60 minutes after the ad libitum use session on days 1, 2, 3 and 4 |
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| Secondary | Sensory Parameters | Measured with a Sensory Questionnaire (SQ) following the ad libitum use period. Response to each question is assessed on a 7-point scale, ranging from 1 (not at all) to 7 (extremely). | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Within 60 minutes after the ad libitum use session on days 1, 2, 3 and 4 |
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| Secondary | Human Puffing Topography (HPT) Parameters (Puff Volume) of Four P3P Variants During the Fixed Puffing Regimen Period. | Descriptive statistics of total puff volume and average puff volume, of four P3P variants, during the fixed puffing regimen period. | Posted | Geometric Mean | 95% Confidence Interval | mL | During fixed puffing product use on days 1, 2, 3 and 4 |
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| Secondary | Human Puffing Topography (HPT) Parameters (Puff Volume) of Four P3P Variants During the ad Libitum Use Period. | Descriptive statistics of total puff volume and average puff volume, of four P3P variants, during the ad libitum use period. | Posted | Geometric Mean | 95% Confidence Interval | mL | During ad libitum product use on days 1, 2, 3 and 4 |
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| Secondary | Amount of Powder Aerosolized From P3P From the Fixed Puffing Regimen. | Descriptive statistics of P3P weight before use, and after use, for the fixed puffing regimen. | Posted | Mean | Standard Deviation | mg | Before and after fixed puffing product use on days 1, 2, 3 and 4 |
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| Secondary | Amount of Powder Aerosolized From P3P From the ad Libitum Use Period (Per Product Used). | P3P weight before use, and after use, to determine the amount of powder aerosolized from P3P during Ad Libitum use (per product used). | Posted | Mean | Standard Deviation | mg | Before and after ad libitum product use on days 1, 2, 3 and 4 |
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| 0 |
| 18 |
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| 18 |
| 4 |
| 18 |
| EG001 | Safety Population (P3P 2) | Comprising enrolled subjects who were exposed to P3P 2 during the study. | 0 | 18 | 0 | 18 | 5 | 18 |
| EG002 | Safety Population (P3P 3) | Comprising enrolled subjects who were exposed to P3P 3 during the study. | 0 | 19 | 0 | 19 | 4 | 19 |
| EG003 | Safety Population (P3P 4) | Comprising enrolled subjects who were exposed to P3P 4 during the study. | 0 | 18 | 0 | 18 | 3 | 18 |
| Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | Non-systematic Assessment |
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| Headache | Nervous system disorders | Non-systematic Assessment |
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| Lymphocytes increased | Investigations | Non-systematic Assessment |
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| Neutrophils decreased | Investigations | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | Non-systematic Assessment |
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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.
| 20 minutes after start of ad libitum product use |
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| 30 minutes after start of ad libitum product use |
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| 40 minutes after start of ad libitum product use |
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| 1 hour after start of ad libitum product use |
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| 2 hours after start of ad libitum product use |
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| 4 hours after start of ad libitum product use |
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| Enjoyment of Respiratory Tract Sensations |
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| Psychological Reward |
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| Aversion |
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| Craving Reduction |
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| Puffs Harshness |
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| Puffs Similarity to Own Brand |
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| Puffs Strength on Tongue |
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| Puffs Strength in Nose |
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| Puffs Strength in Back of Mouth/Throat |
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| Puff Strength in Windpipe |
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| Puff Strength in Chest |
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| Average Puff Volume (per product) |
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| Average Puff Volume (per product) |
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| Weight after use |
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| Difference of Weight (Before/After Use) |
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| Average Weight after use |
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| Average Difference of Weight (Before/After Use) |
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