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This study evaluated the pharmacokinetic profiles and subjective effects of nicotine from two e-cigarette device platforms with varying concentrations of nicotine lactate (nicotine salt) e-liquid relative to conventional cigarettes. It was designed as a randomized, open-label, cross-over clinical study conducted in 15 healthy US adult smokers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional cigarette | Experimental | The subject's preferred brand of commercially available conventional cigarette |
|
| myblu 25 mg freebase | Active Comparator | myblu pod-system containing 25 mg nicotine ('freebase') tobacco flavour |
|
| myblu 16 mg nicotine salt | Active Comparator | myblu pod-system containing 16 mg nicotine salt tobacco flavour |
|
| myblu 25 mg nicotine salt | Active Comparator | myblu pod-system containing 25 mg nicotine salt tobacco flavour |
|
| myblu 40 mg nicotine salt | Active Comparator | myblu pod-system containing 40 mg nicotine salt tobacco flavour |
|
| blu PRO 48 mg nicotine salt | Active Comparator |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Conventional cigarette | Other | Subject's own conventional cigarette brand smoked with puffs taken at 30 seconds intervals |
|
| Measure | Description | Time Frame |
|---|---|---|
| Nicotine pharmacokinetics Cmax | Mean maximum plasma nicotine concentration (Cmax) | 30 minutes following the start of product use (12 measurements over the period) |
| Nicotine pharmacokinetics Tmax | Median time to maximum plasma nicotine concentration (Tmax) | 30 minutes following the start of product use (12 measurements over the period) |
| Nicotine pharmacokinetics AUC0-30 | Mean area under the plasma nicotine concertation-time curve, from time zero to 30 minutes (AUC0-30) | 30 minutes following the start of product use (12 measurements over the period) |
| Measure | Description | Time Frame |
|---|---|---|
| Subjective effects questionnaire | Likert-type scale with responses ranging from 1 (not at all) to 7 (extremely). The following questions were asked: Did it make you dizzy? Did it make you nauseous? Did you enjoy it? Did it relieve the urge to smoke? Was it enough nicotine? Was it too much nicotine? | 20 minutes after the start of product use |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Celerion | Lincoln | Nebraska | 68502 | United States |
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blu PRO open-system containing 48 mg nicotine salt tobacco flavour |
|
| myblu 25 mg freebase | Other | E-cigarette used for 10 inhalations every 30 seconds |
|
| myblu 16 mg nicotine salt | Other | E-cigarette used for 10 inhalations every 30 seconds |
|
| myblu 25 mg nicotine salt | Other | E-cigarette used for 10 inhalations every 30 seconds |
|
| myblu 40 mg nicotine salt | Other | E-cigarette used for 10 inhalations every 30 seconds |
|
| blu PRO 48 mg nicotine salt | Other | E-cigarette used for 10 inhalations every 30 seconds |
|
| Incidence and nature of any adverse events (AE) |
Incidence and nature of any adverse events (AE) (Safety and Tolerability) |
| Through study completion, 6 days |