Trial Outcomes & Findings for Nicotine Lozenge Bioequivalence Study (NCT NCT01536704)
NCT ID: NCT01536704
Last Updated: 2013-04-26
Results Overview
AUC(0-t) was evaluated using the trapezoid rule.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
50 participants
Primary outcome timeframe
Blood samples taken pre-dose and post-dose at 3, 5, 10, 15, 20, 30, 40, and 50 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours
Results posted on
2013-04-26
Participant Flow
Participants were recruited at the clinical site.
Out of 141 participants screened, only 50 were randomized since 91 were screen failures.
Participant milestones
| Measure |
2 Milligram (mg) Cherry Lozenge
Participants were instructed to move the 2mg Cherry mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge.
|
2mg Mint Lozenge
Participants were instructed to move the 2mg Mint (peppermint) mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge.
|
4mg Cherry Lozenge
Participants were instructed to move the 4mg Cherry mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge.
|
4mg Mint Lozenge
Participants were instructed to move the 4mg Mint mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge.
|
|---|---|---|---|---|
|
Period 1
STARTED
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12
|
12
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13
|
13
|
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Period 1
COMPLETED
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12
|
12
|
13
|
13
|
|
Period 1
NOT COMPLETED
|
0
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0
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0
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0
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Washout Period 1
STARTED
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12
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12
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13
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13
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Washout Period 1
COMPLETED
|
11
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10
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13
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13
|
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Washout Period 1
NOT COMPLETED
|
1
|
2
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0
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0
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Period 2
STARTED
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13
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11
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10
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13
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Period 2
COMPLETED
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13
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11
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10
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13
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Period 2
NOT COMPLETED
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0
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0
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0
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0
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Washout Period 2
STARTED
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13
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11
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10
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13
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Washout Period 2
COMPLETED
|
12
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11
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10
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12
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Washout Period 2
NOT COMPLETED
|
1
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0
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0
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1
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Period 3
STARTED
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10
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12
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12
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11
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Period 3
COMPLETED
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10
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12
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12
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10
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Period 3
NOT COMPLETED
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0
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0
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0
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1
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Washout Period 3
STARTED
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10
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12
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12
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10
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Washout Period 3
COMPLETED
|
10
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12
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11
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10
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Washout Period 3
NOT COMPLETED
|
0
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0
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1
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0
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Period 4
STARTED
|
12
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11
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10
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10
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Period 4
COMPLETED
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12
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11
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10
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10
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Period 4
NOT COMPLETED
|
0
|
0
|
0
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0
|
Reasons for withdrawal
| Measure |
2 Milligram (mg) Cherry Lozenge
Participants were instructed to move the 2mg Cherry mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge.
|
2mg Mint Lozenge
Participants were instructed to move the 2mg Mint (peppermint) mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge.
|
4mg Cherry Lozenge
Participants were instructed to move the 4mg Cherry mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge.
|
4mg Mint Lozenge
Participants were instructed to move the 4mg Mint mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge.
|
|---|---|---|---|---|
|
Washout Period 1
Withdrawal by Subject
|
1
|
2
|
0
|
0
|
|
Washout Period 2
Adverse Event
|
1
|
0
|
0
|
0
|
|
Washout Period 2
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
|
Period 3
Adverse Event
|
0
|
0
|
0
|
1
|
|
Washout Period 3
Adverse Event
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Nicotine Lozenge Bioequivalence Study
Baseline characteristics by cohort
| Measure |
All Randomized Participants
n=50 Participants
All randomized participants were evaluated for baseline measures
|
|---|---|
|
Age Continuous
|
30.3 Years
STANDARD_DEVIATION 9.58 • n=5 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Blood samples taken pre-dose and post-dose at 3, 5, 10, 15, 20, 30, 40, and 50 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hoursPopulation: Analysis was done per intention to treat (ITT) population.
AUC(0-t) was evaluated using the trapezoid rule.
Outcome measures
| Measure |
2mg Cherry Lozenge
n=47 Participants
Participants were instructed to move the 2mg Cherry mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge
|
2mg Mint Lozenge
n=45 Participants
Participants were instructed to move the 2mg Mint (peppermint) mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge
|
4mg Cherry Lozenge
n=45 Participants
Participants were instructed to move the 4mg Cherry mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge
|
4mg Mint Lozenge
n=47 Participants
Participants were instructed to move the 4mg Mint (peppermint) mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge
|
|---|---|---|---|---|
|
Area Under the Plasma Concentration Versus Time Curve From Time Zero to Time t [AUC(0-t)]
|
18.84 nanogram (ng).hour (hr)/millilitre (mL)
Standard Deviation 7.07
|
20.71 nanogram (ng).hour (hr)/millilitre (mL)
Standard Deviation 7.42
|
34.71 nanogram (ng).hour (hr)/millilitre (mL)
Standard Deviation 14.48
|
33.68 nanogram (ng).hour (hr)/millilitre (mL)
Standard Deviation 12.17
|
PRIMARY outcome
Timeframe: Blood samples taken pre-dose and post-dose at 3, 5, 10, 15, 20, 30, 40, and 50 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hoursPopulation: Analysis was done per intention to treat (ITT) population.
Cmax was depicted from plasma concentration of nicotine.
Outcome measures
| Measure |
2mg Cherry Lozenge
n=47 Participants
Participants were instructed to move the 2mg Cherry mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge
|
2mg Mint Lozenge
n=45 Participants
Participants were instructed to move the 2mg Mint (peppermint) mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge
|
4mg Cherry Lozenge
n=45 Participants
Participants were instructed to move the 4mg Cherry mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge
|
4mg Mint Lozenge
n=47 Participants
Participants were instructed to move the 4mg Mint (peppermint) mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge
|
|---|---|---|---|---|
|
Maximum Observed Plasma Concentration [Cmaximum (Max)]
|
5.67 ng/mL
Standard Deviation 1.53
|
6.35 ng/mL
Standard Deviation 1.43
|
9.37 ng/mL
Standard Deviation 2.63
|
9.72 ng/mL
Standard Deviation 2.70
|
SECONDARY outcome
Timeframe: Blood samples taken pre-dose and post-dose at 3, 5, 10, 15, 20, 30, 40, and 50 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hoursPopulation: Analysis was done per intention to treat (ITT) population.
AUC (0-inf) was evaluated using the trapezoid rule.
Outcome measures
| Measure |
2mg Cherry Lozenge
n=44 Participants
Participants were instructed to move the 2mg Cherry mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge
|
2mg Mint Lozenge
n=44 Participants
Participants were instructed to move the 2mg Mint (peppermint) mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge
|
4mg Cherry Lozenge
n=45 Participants
Participants were instructed to move the 4mg Cherry mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge
|
4mg Mint Lozenge
n=47 Participants
Participants were instructed to move the 4mg Mint (peppermint) mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge
|
|---|---|---|---|---|
|
AUC [0-infinity (Inf)]
|
21.03 ng.hr/mL
Standard Deviation 8.05
|
22.66 ng.hr/mL
Standard Deviation 8.48
|
37.48 ng.hr/mL
Standard Deviation 16.87
|
36.08 ng.hr/mL
Standard Deviation 13.96
|
SECONDARY outcome
Timeframe: Blood samples taken pre-dose and post-dose at 3, 5, 10, 15, 20, 30, 40, and 50 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hoursPopulation: Analysis was done per intention to treat (ITT) population.
Tmax was time at which Cmax of nicotine was reached.
Outcome measures
| Measure |
2mg Cherry Lozenge
n=47 Participants
Participants were instructed to move the 2mg Cherry mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge
|
2mg Mint Lozenge
n=45 Participants
Participants were instructed to move the 2mg Mint (peppermint) mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge
|
4mg Cherry Lozenge
n=45 Participants
Participants were instructed to move the 4mg Cherry mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge
|
4mg Mint Lozenge
n=47 Participants
Participants were instructed to move the 4mg Mint (peppermint) mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge
|
|---|---|---|---|---|
|
Time to Reach Maximum Plasma Nicotine Concentration (Tmax)
|
0.83 hr
Interval 0.3 to 2.0
|
0.67 hr
Interval 0.3 to 2.0
|
0.83 hr
Interval 0.3 to 2.0
|
0.83 hr
Interval 0.3 to 2.0
|
SECONDARY outcome
Timeframe: Blood samples taken pre-dose and post-dose at 3, 5, 10, 15, 20, 30, 40, and 50 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hoursPopulation: Analysis was done per intention to treat (ITT) population.
T(1/2) was calculated using plasma time-concentration values.
Outcome measures
| Measure |
2mg Cherry Lozenge
n=44 Participants
Participants were instructed to move the 2mg Cherry mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge
|
2mg Mint Lozenge
n=44 Participants
Participants were instructed to move the 2mg Mint (peppermint) mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge
|
4mg Cherry Lozenge
n=45 Participants
Participants were instructed to move the 4mg Cherry mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge
|
4mg Mint Lozenge
n=47 Participants
Participants were instructed to move the 4mg Mint (peppermint) mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge
|
|---|---|---|---|---|
|
Apparent Elimination Half-life of Nicotine T(1/2)
|
3.39 hr
Interval 1.4 to 5.0
|
3.41 hr
Interval 1.4 to 6.6
|
3.19 hr
Interval 1.5 to 5.3
|
3.13 hr
Interval 1.4 to 5.3
|
SECONDARY outcome
Timeframe: Blood samples taken pre-dose and post-dose at 3, 5, 10, 15, 20, 30, 40, and 50 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hoursPopulation: Analysis was done per intention to treat (ITT) population.
Kel was calculated with the help of plasma time concentration values.
Outcome measures
| Measure |
2mg Cherry Lozenge
n=44 Participants
Participants were instructed to move the 2mg Cherry mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge
|
2mg Mint Lozenge
n=44 Participants
Participants were instructed to move the 2mg Mint (peppermint) mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge
|
4mg Cherry Lozenge
n=45 Participants
Participants were instructed to move the 4mg Cherry mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge
|
4mg Mint Lozenge
n=47 Participants
Participants were instructed to move the 4mg Mint (peppermint) mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge
|
|---|---|---|---|---|
|
Elimination Rate Constant for Plasma Nicotine: K (el)
|
0.20 1/hr
Interval 0.1 to 0.5
|
0.20 1/hr
Interval 0.1 to 0.5
|
0.22 1/hr
Interval 0.1 to 0.5
|
0.22 1/hr
Interval 0.1 to 0.5
|
Adverse Events
2mg Cherry Lozenge
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
2mg Mint Lozenge
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
4mg Cherry Lozenge
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
4mg Mint Lozenge
Serious events: 1 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
2mg Cherry Lozenge
n=47 participants at risk
Participants were instructed to move the 2mg Cherry mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge.
|
2mg Mint Lozenge
n=46 participants at risk
Participants were instructed to move the 2mg Mint (peppermint) mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge.
|
4mg Cherry Lozenge
n=45 participants at risk
Participants were instructed to move the 4mg Cherry mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge
|
4mg Mint Lozenge
n=47 participants at risk
Participants were instructed to move the 4mg Mint (peppermint) mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge
|
|---|---|---|---|---|
|
Infections and infestations
Appendicitis
|
0.00%
0/47 • Adverse Events were collected from the starting time of the investigational product, and until 5 days following last administration of the investigational product.
|
0.00%
0/46 • Adverse Events were collected from the starting time of the investigational product, and until 5 days following last administration of the investigational product.
|
0.00%
0/45 • Adverse Events were collected from the starting time of the investigational product, and until 5 days following last administration of the investigational product.
|
2.1%
1/47 • Number of events 1 • Adverse Events were collected from the starting time of the investigational product, and until 5 days following last administration of the investigational product.
|
Other adverse events
| Measure |
2mg Cherry Lozenge
n=47 participants at risk
Participants were instructed to move the 2mg Cherry mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge.
|
2mg Mint Lozenge
n=46 participants at risk
Participants were instructed to move the 2mg Mint (peppermint) mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge.
|
4mg Cherry Lozenge
n=45 participants at risk
Participants were instructed to move the 4mg Cherry mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge
|
4mg Mint Lozenge
n=47 participants at risk
Participants were instructed to move the 4mg Mint (peppermint) mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Dyspepsia
|
4.3%
2/47 • Number of events 2 • Adverse Events were collected from the starting time of the investigational product, and until 5 days following last administration of the investigational product.
|
0.00%
0/46 • Adverse Events were collected from the starting time of the investigational product, and until 5 days following last administration of the investigational product.
|
6.7%
3/45 • Number of events 3 • Adverse Events were collected from the starting time of the investigational product, and until 5 days following last administration of the investigational product.
|
8.5%
4/47 • Number of events 4 • Adverse Events were collected from the starting time of the investigational product, and until 5 days following last administration of the investigational product.
|
|
Gastrointestinal disorders
Nausea
|
2.1%
1/47 • Number of events 1 • Adverse Events were collected from the starting time of the investigational product, and until 5 days following last administration of the investigational product.
|
2.2%
1/46 • Number of events 1 • Adverse Events were collected from the starting time of the investigational product, and until 5 days following last administration of the investigational product.
|
2.2%
1/45 • Number of events 1 • Adverse Events were collected from the starting time of the investigational product, and until 5 days following last administration of the investigational product.
|
8.5%
4/47 • Number of events 4 • Adverse Events were collected from the starting time of the investigational product, and until 5 days following last administration of the investigational product.
|
|
Nervous system disorders
Headache
|
2.1%
1/47 • Number of events 1 • Adverse Events were collected from the starting time of the investigational product, and until 5 days following last administration of the investigational product.
|
4.3%
2/46 • Number of events 2 • Adverse Events were collected from the starting time of the investigational product, and until 5 days following last administration of the investigational product.
|
8.9%
4/45 • Number of events 4 • Adverse Events were collected from the starting time of the investigational product, and until 5 days following last administration of the investigational product.
|
2.1%
1/47 • Number of events 1 • Adverse Events were collected from the starting time of the investigational product, and until 5 days following last administration of the investigational product.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/47 • Adverse Events were collected from the starting time of the investigational product, and until 5 days following last administration of the investigational product.
|
6.5%
3/46 • Number of events 3 • Adverse Events were collected from the starting time of the investigational product, and until 5 days following last administration of the investigational product.
|
2.2%
1/45 • Number of events 1 • Adverse Events were collected from the starting time of the investigational product, and until 5 days following last administration of the investigational product.
|
2.1%
1/47 • Number of events 1 • Adverse Events were collected from the starting time of the investigational product, and until 5 days following last administration of the investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Throat Irritation
|
4.3%
2/47 • Number of events 2 • Adverse Events were collected from the starting time of the investigational product, and until 5 days following last administration of the investigational product.
|
4.3%
2/46 • Number of events 2 • Adverse Events were collected from the starting time of the investigational product, and until 5 days following last administration of the investigational product.
|
6.7%
3/45 • Number of events 3 • Adverse Events were collected from the starting time of the investigational product, and until 5 days following last administration of the investigational product.
|
2.1%
1/47 • Number of events 1 • Adverse Events were collected from the starting time of the investigational product, and until 5 days following last administration of the investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/47 • Adverse Events were collected from the starting time of the investigational product, and until 5 days following last administration of the investigational product.
|
2.2%
1/46 • Number of events 1 • Adverse Events were collected from the starting time of the investigational product, and until 5 days following last administration of the investigational product.
|
2.2%
1/45 • Number of events 1 • Adverse Events were collected from the starting time of the investigational product, and until 5 days following last administration of the investigational product.
|
8.5%
4/47 • Number of events 4 • Adverse Events were collected from the starting time of the investigational product, and until 5 days following last administration of the investigational product.
|
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER