Trial Outcomes & Findings for To Assess the Bioequivalence of the 4mg Prototype Mini Nicotine Lozenge to the Reference Product (Nicorette) in Healthy Smokers (NCT NCT03543137)
NCT ID: NCT03543137
Last Updated: 2019-12-04
Results Overview
Bioequivalence of prototype mini lozenges with nicorette mini lozenge was assessed by measuring AUC(0-t), where t= time of the last measurable plasma concentration. AUC(0-t) was calculated using the linear trapezoidal with linear interpolation method. A linear mixed-effects model was fit to the natural log (ln)-transformed PK variable (AUC0-t), as the dependent variable, and treatment, period, and sequence as fixed effects. Participant nested within sequence was a random effect. The treatment difference and its 90% CI were exponentiated to obtain the geometric mean ratios (GMR) between the test and reference products and its 90% CI. Geometric Coefficient of variation was provided as percentage.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
37 participants
Primary outcome timeframe
0.75, 0.5, 0.25 hours predose and 0.08, 0.17, 0.33, 0.5, 0.67, 0.83, 1, 1.25, 1.5, 2, 3, 4, 6, 8 10, 14, 16, 20 and 24 hours postdose in each treatment period
Results posted on
2019-12-04
Participant Flow
The study was conducted at single center in United States. A total of 61 participants were screened, of whom 37 were randomized for treatment and 24 were screen failures.
Participants received treatment in one of the two sequences; treatment A (Prototype Mini Lozenge: Reference drug) followed by treatment B (Nicorette Mini lozenge: Investigational drug) or vice versa in each of the study period 1 and 2.
Participant milestones
| Measure |
Prototype-Washout-Nicorette
Participants randomized to this group received a single dose of Treatment A: 4 milligrams (mg) of Prototype Mini Lozenge administered orally on Day 0 in Treatment Period 1. It was followed by a washout period of at least 5 days to a maximum of 7 days, then participants received Treatment B: 4 mg of Nicorette Mini lozenge administered orally on any one day from Day 5-Day 7 (depending upon washout period) in Treatment Period 2. All these doses were administered after an overnight fast of at least 10 hours in each period. Participants were confined in the study facility for approximately 60 hours during each treatment period (for 36 hours predose and for 24 hours postdose) with abstinence from smoking during which they were subjected to random measurements of expired carbon monoxide (CO) to confirm abstinence (CO levels must have been less than or equal to(\<=) 10 parts per million (ppm) throughout the treatment period).
|
Nicorette-Washout-Prototype
Participants randomized to this group received a single dose of Treatment B: 4 mg of Nicorette Mini lozenge administered orally on Day 0 in Treatment Period 1. It was followed by a washout period of at least 5 days to a maximum of 7 days, then participants received Treatment A: 4 mg of Prototype Mini Lozenge administered orally on any one day from Day 5-Day 7 (depending upon washout period) in Treatment Period 2. All these doses were administered after an overnight fast of at least 10 hours in each period. Participants were confined in the study facility for approximately 60 hours during each treatment period (for 36 hours predose and for 24 hours postdose) with abstinence from smoking during which they were subjected to random measurements of expired CO to confirm abstinence (CO levels must have been \<= 10 ppm throughout the treatment period).
|
|---|---|---|
|
Study Period 1: Up to Day 1
STARTED
|
18
|
19
|
|
Study Period 1: Up to Day 1
COMPLETED
|
18
|
19
|
|
Study Period 1: Up to Day 1
NOT COMPLETED
|
0
|
0
|
|
Washout Period: 5 to 7 Days
STARTED
|
18
|
19
|
|
Washout Period: 5 to 7 Days
COMPLETED
|
18
|
19
|
|
Washout Period: 5 to 7 Days
NOT COMPLETED
|
0
|
0
|
|
Study Period 2: Up to Day 8
STARTED
|
18
|
19
|
|
Study Period 2: Up to Day 8
Treated
|
16
|
18
|
|
Study Period 2: Up to Day 8
COMPLETED
|
16
|
18
|
|
Study Period 2: Up to Day 8
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
Prototype-Washout-Nicorette
Participants randomized to this group received a single dose of Treatment A: 4 milligrams (mg) of Prototype Mini Lozenge administered orally on Day 0 in Treatment Period 1. It was followed by a washout period of at least 5 days to a maximum of 7 days, then participants received Treatment B: 4 mg of Nicorette Mini lozenge administered orally on any one day from Day 5-Day 7 (depending upon washout period) in Treatment Period 2. All these doses were administered after an overnight fast of at least 10 hours in each period. Participants were confined in the study facility for approximately 60 hours during each treatment period (for 36 hours predose and for 24 hours postdose) with abstinence from smoking during which they were subjected to random measurements of expired carbon monoxide (CO) to confirm abstinence (CO levels must have been less than or equal to(\<=) 10 parts per million (ppm) throughout the treatment period).
|
Nicorette-Washout-Prototype
Participants randomized to this group received a single dose of Treatment B: 4 mg of Nicorette Mini lozenge administered orally on Day 0 in Treatment Period 1. It was followed by a washout period of at least 5 days to a maximum of 7 days, then participants received Treatment A: 4 mg of Prototype Mini Lozenge administered orally on any one day from Day 5-Day 7 (depending upon washout period) in Treatment Period 2. All these doses were administered after an overnight fast of at least 10 hours in each period. Participants were confined in the study facility for approximately 60 hours during each treatment period (for 36 hours predose and for 24 hours postdose) with abstinence from smoking during which they were subjected to random measurements of expired CO to confirm abstinence (CO levels must have been \<= 10 ppm throughout the treatment period).
|
|---|---|---|
|
Study Period 2: Up to Day 8
Withdrawal by Subject
|
1
|
0
|
|
Study Period 2: Up to Day 8
Protocol Violation
|
1
|
0
|
|
Study Period 2: Up to Day 8
Adverse Event
|
0
|
1
|
Baseline Characteristics
To Assess the Bioequivalence of the 4mg Prototype Mini Nicotine Lozenge to the Reference Product (Nicorette) in Healthy Smokers
Baseline characteristics by cohort
| Measure |
All Treatment Combined
n=37 Participants
All randomized participants received either a single dose of TreatmentA:4mg of Prototype Mini Lozenge administered orally on Day0 in Treatment Period1 followed by TreatmentB:4mg of Nicorette Mini lozenge administered orally on any one day from Day 5-Day 7(depending upon washout period) in Treatment Period2 or vice versa. Washout period was of at least 5days to maximum of 7days between two treatment periods. All these doses were administered after an overnight fast of at least 10 hours in each period. Participants were confined in the study facility for approximately 60 hours during each treatment period (for 36 hours predose and for 24 hours postdose) with abstinence from smoking during which they were subjected to random measurements of expired CO to confirm abstinence (CO levels must have been \<=10 ppm throughout the treatment period).
|
|---|---|
|
Age, Continuous
|
36.9 years
STANDARD_DEVIATION 9.07 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
37 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
30 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 0.75, 0.5, 0.25 hours predose and 0.08, 0.17, 0.33, 0.5, 0.67, 0.83, 1, 1.25, 1.5, 2, 3, 4, 6, 8 10, 14, 16, 20 and 24 hours postdose in each treatment periodPopulation: Pharmacokinetic analysis set1 (PKAS1) included all randomized participants who completed both periods, had no major protocol deviations concerning pharmacokinetics, excluding those with baseline nicotine concentration greater than (\>) 5 percent (%) of individual highest observed plasma nicotine concentration (Cmax) for either period.
Bioequivalence of prototype mini lozenges with nicorette mini lozenge was assessed by measuring AUC(0-t), where t= time of the last measurable plasma concentration. AUC(0-t) was calculated using the linear trapezoidal with linear interpolation method. A linear mixed-effects model was fit to the natural log (ln)-transformed PK variable (AUC0-t), as the dependent variable, and treatment, period, and sequence as fixed effects. Participant nested within sequence was a random effect. The treatment difference and its 90% CI were exponentiated to obtain the geometric mean ratios (GMR) between the test and reference products and its 90% CI. Geometric Coefficient of variation was provided as percentage.
Outcome measures
| Measure |
Prototype Mini Lozenges
n=27 Participants
Participants randomized to receive a single dose of Treatment A: 4 mg of Prototype Mini Lozenge administered orally in either Treatment Period 1 (on Day 1) or Treatment Period 2 (Day 5 to 7). All these doses were administered after an overnight fast of at least 10 hours in each period. Participants were confined in the study facility for approximately 60 hours during each treatment period (for 36 hours predose and for 24 hours postdose) with abstinence from smoking during which they were subjected to random measurements of expired CO to confirm abstinence (CO levels must have been \<= 10 ppm throughout the treatment period).
|
Nicorette Mini Lozenges
n=27 Participants
Participants randomized to receive a single dose of Treatment B: 4 mg of Nicorette Mini lozenge administered orally in either Treatment Period 1 (on Day 5 to 7) or Treatment Period 2 (Day 1). All these doses were administered after an overnight fast of at least 10 hours in each period. Participants were confined in the study facility for approximately 60 hours during each treatment period (for 36 hours predose and for 24 hours postdose) with abstinence from smoking during which they were subjected to random measurements of expired CO to confirm abstinence (CO levels must have been \<= 10 ppm throughout the treatment period).
|
All Treatment Combined
All randomized participants received either a single dose of TreatmentA:4mg of Prototype Mini Lozenge administered orally on Day0 in Treatment Period1 followed by TreatmentB:4mg of Nicorette Mini lozenge administered orally on any one day from Day 5-Day 7(depending upon washout period) in Treatment Period2 or vice versa. Washout period was of at least 5days to maximum of 7days between two treatment periods. All these doses were administered after an overnight fast of at least 10 hours in each period. Participants were confined in the study facility for approximately 60 hours during each treatment period (for 36 hours predose and for 24 hours postdose) with abstinence from smoking during which they were subjected to random measurements of expired CO to confirm abstinence (CO levels must have been \<=10 ppm throughout the treatment period).
|
|---|---|---|---|
|
Assessment of Bioequivalence of Prototype Mini Lozenges With Nicorette Mini Lozenge by Measuring Area Under the Plasma Concentration Versus Time Curve From Time Zero to Time t (AUC [0-t])
|
34.44 nanograms*hours per milliliter(ng*hr/mL)
Geometric Coefficient of Variation 51.5
|
36.39 nanograms*hours per milliliter(ng*hr/mL)
Geometric Coefficient of Variation 43.9
|
—
|
PRIMARY outcome
Timeframe: 0.75, 0.5, 0.25 hours predose and 0.08, 0.17, 0.33, 0.5, 0.67, 0.83, 1, 1.25, 1.5, 2, 3, 4, 6, 8 10, 14, 16, 20 and 24 hours postdose in each treatment periodPopulation: Analysis performed on PKAS1, that included all randomized participants who completed both periods, had no major protocol deviations concerning pharmacokinetics, excluding those with baseline nicotine concentration \> 5% of individual Cmax for either period. Here, number analyzed indicates participants with available data for this outcome measure.
Bioequivalence of prototype mini lozenges with nicorette mini lozenge was assessed by measuring AUC(0-inf). AUC(0-inf) = AUC0-t + (Clast/kel), where, AUC0-t= area under the plasma concentration versus time curve from time zero to time t; Clast= last observed/measured plasma concentration and kel= elimination rate constant. A linear mixed-effects model was fit to the natural log (ln)-transformed PK variable (AUC\[0-inf\]), as the dependent variable, and treatment, period, and sequence as fixed effects. Participant nested within sequence was a random effect. The treatment difference and its 90% CI were exponentiated to obtain the GMR between the test and reference products and its 90% CI. Geometric Coefficient of variation was provided as percentage.
Outcome measures
| Measure |
Prototype Mini Lozenges
n=27 Participants
Participants randomized to receive a single dose of Treatment A: 4 mg of Prototype Mini Lozenge administered orally in either Treatment Period 1 (on Day 1) or Treatment Period 2 (Day 5 to 7). All these doses were administered after an overnight fast of at least 10 hours in each period. Participants were confined in the study facility for approximately 60 hours during each treatment period (for 36 hours predose and for 24 hours postdose) with abstinence from smoking during which they were subjected to random measurements of expired CO to confirm abstinence (CO levels must have been \<= 10 ppm throughout the treatment period).
|
Nicorette Mini Lozenges
n=27 Participants
Participants randomized to receive a single dose of Treatment B: 4 mg of Nicorette Mini lozenge administered orally in either Treatment Period 1 (on Day 5 to 7) or Treatment Period 2 (Day 1). All these doses were administered after an overnight fast of at least 10 hours in each period. Participants were confined in the study facility for approximately 60 hours during each treatment period (for 36 hours predose and for 24 hours postdose) with abstinence from smoking during which they were subjected to random measurements of expired CO to confirm abstinence (CO levels must have been \<= 10 ppm throughout the treatment period).
|
All Treatment Combined
All randomized participants received either a single dose of TreatmentA:4mg of Prototype Mini Lozenge administered orally on Day0 in Treatment Period1 followed by TreatmentB:4mg of Nicorette Mini lozenge administered orally on any one day from Day 5-Day 7(depending upon washout period) in Treatment Period2 or vice versa. Washout period was of at least 5days to maximum of 7days between two treatment periods. All these doses were administered after an overnight fast of at least 10 hours in each period. Participants were confined in the study facility for approximately 60 hours during each treatment period (for 36 hours predose and for 24 hours postdose) with abstinence from smoking during which they were subjected to random measurements of expired CO to confirm abstinence (CO levels must have been \<=10 ppm throughout the treatment period).
|
|---|---|---|---|
|
Assessment of Bioequivalence of Prototype Mini Lozenges With Nicorette Mini Lozenge by Measuring Area Under the Plasma Concentration Versus Time Curve Calculated From Time Zero to Infinity (AUC [(0-inf])
|
36.39 ng*hr/mL
Geometric Coefficient of Variation 52.0
|
38.54 ng*hr/mL
Geometric Coefficient of Variation 43.6
|
—
|
PRIMARY outcome
Timeframe: 0.75, 0.5, 0.25 hours predose and 0.08, 0.17, 0.33, 0.5, 0.67, 0.83, 1, 1.25, 1.5, 2, 3, 4, 6, 8 10, 14, 16, 20 and 24 hours postdose in each treatment periodPopulation: Analysis performed on PKAS1, that included all randomized participants who completed both periods, had no major protocol deviations concerning pharmacokinetics, excluding those with baseline nicotine concentration \> 5% of individual Cmax for either period.
Blood samples were collected at designated timepoints. Bioequivalence of prototype mini lozenges with nicorette mini lozenge was assessed by measuring Cmax that was taken directly from bioanalytical data. Geometric Coefficient of variation was provided as percentage. A linear mixed-effects model was fit to the natural log (ln)-transformed PK variable (Cmax) as the dependent variable, and treatment, period, and sequence as fixed effects. Participant nested within sequence was a random effect. The treatment difference and its 90% CI were exponentiated to obtain the GMR between the test and reference products and its 90% CI. Geometric Coefficient of variation was provided as percentage.
Outcome measures
| Measure |
Prototype Mini Lozenges
n=27 Participants
Participants randomized to receive a single dose of Treatment A: 4 mg of Prototype Mini Lozenge administered orally in either Treatment Period 1 (on Day 1) or Treatment Period 2 (Day 5 to 7). All these doses were administered after an overnight fast of at least 10 hours in each period. Participants were confined in the study facility for approximately 60 hours during each treatment period (for 36 hours predose and for 24 hours postdose) with abstinence from smoking during which they were subjected to random measurements of expired CO to confirm abstinence (CO levels must have been \<= 10 ppm throughout the treatment period).
|
Nicorette Mini Lozenges
n=27 Participants
Participants randomized to receive a single dose of Treatment B: 4 mg of Nicorette Mini lozenge administered orally in either Treatment Period 1 (on Day 5 to 7) or Treatment Period 2 (Day 1). All these doses were administered after an overnight fast of at least 10 hours in each period. Participants were confined in the study facility for approximately 60 hours during each treatment period (for 36 hours predose and for 24 hours postdose) with abstinence from smoking during which they were subjected to random measurements of expired CO to confirm abstinence (CO levels must have been \<= 10 ppm throughout the treatment period).
|
All Treatment Combined
All randomized participants received either a single dose of TreatmentA:4mg of Prototype Mini Lozenge administered orally on Day0 in Treatment Period1 followed by TreatmentB:4mg of Nicorette Mini lozenge administered orally on any one day from Day 5-Day 7(depending upon washout period) in Treatment Period2 or vice versa. Washout period was of at least 5days to maximum of 7days between two treatment periods. All these doses were administered after an overnight fast of at least 10 hours in each period. Participants were confined in the study facility for approximately 60 hours during each treatment period (for 36 hours predose and for 24 hours postdose) with abstinence from smoking during which they were subjected to random measurements of expired CO to confirm abstinence (CO levels must have been \<=10 ppm throughout the treatment period).
|
|---|---|---|---|
|
Assessment of Bioequivalence of Prototype Mini Lozenges With Nicorette Mini Lozenge by Measuring Maximum Observed Plasma Nicotine Concentration (Cmax)
|
8.263 nanograms per milliliter
Geometric Coefficient of Variation 36.4
|
8.571 nanograms per milliliter
Geometric Coefficient of Variation 32.0
|
—
|
SECONDARY outcome
Timeframe: 0.75, 0.5, 0.25 hours predose and 0.08, 0.17, 0.33, 0.5, 0.67, 0.83, 1, 1.25, 1.5, 2, 3, 4, 6, 8 10, 14, 16, 20 and 24 hours postdose in each treatment periodPopulation: Analysis performed on PKAS1, that included all randomized participants who completed both periods, had no major protocol deviations concerning pharmacokinetics, excluding those with baseline nicotine concentration \> 5% of individual Cmax for either period.
Tmax was defined as the time to maximum plasma nicotine concentration. If the maximum value occurred at more than one time point, Tmax was defined as the first time point with this value.
Outcome measures
| Measure |
Prototype Mini Lozenges
n=27 Participants
Participants randomized to receive a single dose of Treatment A: 4 mg of Prototype Mini Lozenge administered orally in either Treatment Period 1 (on Day 1) or Treatment Period 2 (Day 5 to 7). All these doses were administered after an overnight fast of at least 10 hours in each period. Participants were confined in the study facility for approximately 60 hours during each treatment period (for 36 hours predose and for 24 hours postdose) with abstinence from smoking during which they were subjected to random measurements of expired CO to confirm abstinence (CO levels must have been \<= 10 ppm throughout the treatment period).
|
Nicorette Mini Lozenges
n=27 Participants
Participants randomized to receive a single dose of Treatment B: 4 mg of Nicorette Mini lozenge administered orally in either Treatment Period 1 (on Day 5 to 7) or Treatment Period 2 (Day 1). All these doses were administered after an overnight fast of at least 10 hours in each period. Participants were confined in the study facility for approximately 60 hours during each treatment period (for 36 hours predose and for 24 hours postdose) with abstinence from smoking during which they were subjected to random measurements of expired CO to confirm abstinence (CO levels must have been \<= 10 ppm throughout the treatment period).
|
All Treatment Combined
All randomized participants received either a single dose of TreatmentA:4mg of Prototype Mini Lozenge administered orally on Day0 in Treatment Period1 followed by TreatmentB:4mg of Nicorette Mini lozenge administered orally on any one day from Day 5-Day 7(depending upon washout period) in Treatment Period2 or vice versa. Washout period was of at least 5days to maximum of 7days between two treatment periods. All these doses were administered after an overnight fast of at least 10 hours in each period. Participants were confined in the study facility for approximately 60 hours during each treatment period (for 36 hours predose and for 24 hours postdose) with abstinence from smoking during which they were subjected to random measurements of expired CO to confirm abstinence (CO levels must have been \<=10 ppm throughout the treatment period).
|
|---|---|---|---|
|
Comparison of Prototype Mini Lozenges With Nicorette Mini Lozenge by Measuring Time of Maximum Plasma Nicotine Concentration (Tmax)
|
1.493 hour
Interval 1.25 to 1.507
|
1.250 hour
Interval 1.008 to 1.999
|
—
|
SECONDARY outcome
Timeframe: 0.75, 0.5, 0.25 hours predose and 0.08, 0.17, 0.33, 0.5, 0.67, 0.83, 1, 1.25, 1.5, 2, 3, 4, 6, 8 10, 14, 16, 20 and 24 hours postdose in each treatment periodPopulation: Analysis performed on PKAS1, that included all randomized participants who completed both periods, had no major protocol deviations concerning pharmacokinetics, excluding those with baseline nicotine concentration \> 5% of individual Cmax for either period. Here, number analyzed indicates participants with available data for this outcome measure.
t1/2 was defined as apparent elimination half-life that was calculated as t1/2 = ln(2) / Kel, where Kel= elimination rate constant.
Outcome measures
| Measure |
Prototype Mini Lozenges
n=27 Participants
Participants randomized to receive a single dose of Treatment A: 4 mg of Prototype Mini Lozenge administered orally in either Treatment Period 1 (on Day 1) or Treatment Period 2 (Day 5 to 7). All these doses were administered after an overnight fast of at least 10 hours in each period. Participants were confined in the study facility for approximately 60 hours during each treatment period (for 36 hours predose and for 24 hours postdose) with abstinence from smoking during which they were subjected to random measurements of expired CO to confirm abstinence (CO levels must have been \<= 10 ppm throughout the treatment period).
|
Nicorette Mini Lozenges
n=27 Participants
Participants randomized to receive a single dose of Treatment B: 4 mg of Nicorette Mini lozenge administered orally in either Treatment Period 1 (on Day 5 to 7) or Treatment Period 2 (Day 1). All these doses were administered after an overnight fast of at least 10 hours in each period. Participants were confined in the study facility for approximately 60 hours during each treatment period (for 36 hours predose and for 24 hours postdose) with abstinence from smoking during which they were subjected to random measurements of expired CO to confirm abstinence (CO levels must have been \<= 10 ppm throughout the treatment period).
|
All Treatment Combined
All randomized participants received either a single dose of TreatmentA:4mg of Prototype Mini Lozenge administered orally on Day0 in Treatment Period1 followed by TreatmentB:4mg of Nicorette Mini lozenge administered orally on any one day from Day 5-Day 7(depending upon washout period) in Treatment Period2 or vice versa. Washout period was of at least 5days to maximum of 7days between two treatment periods. All these doses were administered after an overnight fast of at least 10 hours in each period. Participants were confined in the study facility for approximately 60 hours during each treatment period (for 36 hours predose and for 24 hours postdose) with abstinence from smoking during which they were subjected to random measurements of expired CO to confirm abstinence (CO levels must have been \<=10 ppm throughout the treatment period).
|
|---|---|---|---|
|
Comparison of Prototype Mini Lozenges With Nicorette Mini Lozenge by Measuring Apparent Elimination Half-Life (t1/2)
|
5.925 hour
Interval 1.54 to 13.9
|
6.324 hour
Interval 1.98 to 16.3
|
—
|
SECONDARY outcome
Timeframe: 0.75, 0.5, 0.25 hours predose and 0.08, 0.17, 0.33, 0.5, 0.67, 0.83, 1, 1.25, 1.5, 2, 3, 4, 6, 8 10, 14, 16, 20 and 24 hours postdose in each treatment periodPopulation: Analysis performed on PKAS1, that included all randomized participants who completed both periods, had no major protocol deviations concerning pharmacokinetics, excluding those with baseline nicotine concentration \> 5% of individual Cmax for either period. Here, number analyzed indicates participants with available data for this outcome measure.
kel was defined as apparent elimination rate constant for plasma nicotine that was calculated as negative of the slope of a linear regression of the log(concentration)- time for all concentrations \> lower limit of quantification.
Outcome measures
| Measure |
Prototype Mini Lozenges
n=27 Participants
Participants randomized to receive a single dose of Treatment A: 4 mg of Prototype Mini Lozenge administered orally in either Treatment Period 1 (on Day 1) or Treatment Period 2 (Day 5 to 7). All these doses were administered after an overnight fast of at least 10 hours in each period. Participants were confined in the study facility for approximately 60 hours during each treatment period (for 36 hours predose and for 24 hours postdose) with abstinence from smoking during which they were subjected to random measurements of expired CO to confirm abstinence (CO levels must have been \<= 10 ppm throughout the treatment period).
|
Nicorette Mini Lozenges
n=27 Participants
Participants randomized to receive a single dose of Treatment B: 4 mg of Nicorette Mini lozenge administered orally in either Treatment Period 1 (on Day 5 to 7) or Treatment Period 2 (Day 1). All these doses were administered after an overnight fast of at least 10 hours in each period. Participants were confined in the study facility for approximately 60 hours during each treatment period (for 36 hours predose and for 24 hours postdose) with abstinence from smoking during which they were subjected to random measurements of expired CO to confirm abstinence (CO levels must have been \<= 10 ppm throughout the treatment period).
|
All Treatment Combined
All randomized participants received either a single dose of TreatmentA:4mg of Prototype Mini Lozenge administered orally on Day0 in Treatment Period1 followed by TreatmentB:4mg of Nicorette Mini lozenge administered orally on any one day from Day 5-Day 7(depending upon washout period) in Treatment Period2 or vice versa. Washout period was of at least 5days to maximum of 7days between two treatment periods. All these doses were administered after an overnight fast of at least 10 hours in each period. Participants were confined in the study facility for approximately 60 hours during each treatment period (for 36 hours predose and for 24 hours postdose) with abstinence from smoking during which they were subjected to random measurements of expired CO to confirm abstinence (CO levels must have been \<=10 ppm throughout the treatment period).
|
|---|---|---|---|
|
Comparison of Prototype Mini Lozenges With Nicorette Mini Lozenge by Measuring Apparent Elimination Rate Constant for Plasma Nicotine (Kel)
|
0.1610 fraction per hour
Interval 0.0499 to 0.449
|
0.1539 fraction per hour
Interval 0.0425 to 0.351
|
—
|
SECONDARY outcome
Timeframe: From signing of the informed consent form until 5 days after last administration of study drug (up to Day 13)Population: Safety population was defined as all randomized participants who received at least one dose of study medication.
Haematological, biochemistry and urinalysis parameters were analyzed. Clinical significance was judged by the investigator based upon the out of range values of standard range set for each parameter.
Outcome measures
| Measure |
Prototype Mini Lozenges
n=36 Participants
Participants randomized to receive a single dose of Treatment A: 4 mg of Prototype Mini Lozenge administered orally in either Treatment Period 1 (on Day 1) or Treatment Period 2 (Day 5 to 7). All these doses were administered after an overnight fast of at least 10 hours in each period. Participants were confined in the study facility for approximately 60 hours during each treatment period (for 36 hours predose and for 24 hours postdose) with abstinence from smoking during which they were subjected to random measurements of expired CO to confirm abstinence (CO levels must have been \<= 10 ppm throughout the treatment period).
|
Nicorette Mini Lozenges
n=35 Participants
Participants randomized to receive a single dose of Treatment B: 4 mg of Nicorette Mini lozenge administered orally in either Treatment Period 1 (on Day 5 to 7) or Treatment Period 2 (Day 1). All these doses were administered after an overnight fast of at least 10 hours in each period. Participants were confined in the study facility for approximately 60 hours during each treatment period (for 36 hours predose and for 24 hours postdose) with abstinence from smoking during which they were subjected to random measurements of expired CO to confirm abstinence (CO levels must have been \<= 10 ppm throughout the treatment period).
|
All Treatment Combined
n=37 Participants
All randomized participants received either a single dose of TreatmentA:4mg of Prototype Mini Lozenge administered orally on Day0 in Treatment Period1 followed by TreatmentB:4mg of Nicorette Mini lozenge administered orally on any one day from Day 5-Day 7(depending upon washout period) in Treatment Period2 or vice versa. Washout period was of at least 5days to maximum of 7days between two treatment periods. All these doses were administered after an overnight fast of at least 10 hours in each period. Participants were confined in the study facility for approximately 60 hours during each treatment period (for 36 hours predose and for 24 hours postdose) with abstinence from smoking during which they were subjected to random measurements of expired CO to confirm abstinence (CO levels must have been \<=10 ppm throughout the treatment period).
|
|---|---|---|---|
|
Number of Participants With Clinically Significant Change in Laboratory Test Values
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Prototype Mini Lozenges
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Nicorette Mini Lozenges
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
All Treatment Combined
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Prototype Mini Lozenges
n=36 participants at risk
Participants randomized to receive a single dose of Treatment A: 4 mg of Prototype Mini Lozenge administered orally in either Treatment Period 1 (on Day 1) or Treatment Period 2 (Day 5 to 7). All these doses were administered after an overnight fast of at least 10 hours in each period. Participants were confined in the study facility for approximately 60 hours during each treatment period (for 36 hours predose and for 24 hours postdose) with abstinence from smoking during which they were subjected to random measurements of expired CO to confirm abstinence (CO levels must have been \<= 10 ppm throughout the treatment period).
|
Nicorette Mini Lozenges
n=35 participants at risk
Participants randomized to receive a single dose of Treatment B: 4 mg of Nicorette Mini lozenge administered orally in either Treatment Period 1 (on Day 5 to 7) or Treatment Period 2 (Day 1). All these doses were administered after an overnight fast of at least 10 hours in each period. Participants were confined in the study facility for approximately 60 hours during each treatment period (for 36 hours predose and for 24 hours postdose) with abstinence from smoking during which they were subjected to random measurements of expired CO to confirm abstinence (CO levels must have been \<= 10 ppm throughout the treatment period).
|
All Treatment Combined
n=37 participants at risk
All randomized participants received either a single dose of TreatmentA:4mg of Prototype Mini Lozenge administered orally on Day0 in Treatment Period1 followed by TreatmentB:4mg of Nicorette Mini lozenge administered orally on any one day from Day 5-Day 7(depending upon washout period) in Treatment Period2 or vice versa. Washout period was of at least 5days to maximum of 7days between two treatment periods. All these doses were administered after an overnight fast of at least 10 hours in each period. Participants were confined in the study facility for approximately 60 hours during each treatment period (for 36 hours predose and for 24 hours postdose) with abstinence from smoking during which they were subjected to random measurements of expired CO to confirm abstinence (CO levels must have been \<=10 ppm throughout the treatment period).
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/36 • From signing of the informed consent form until 5 days after last administration of study drug (up to Day 13)
Safety population: all randomized participants who received at least one dose of study medication. All adverse events (AEs) were summarized by system organ class and preferred term. All treatment emergent AEs and serious adverse events (SAEs) were collected and reported. A participant with multiple occurrences of AEs counted once in AE category. A participant with multiple AEs within a primary system organ class was counted once in system organ class.
|
2.9%
1/35 • Number of events 1 • From signing of the informed consent form until 5 days after last administration of study drug (up to Day 13)
Safety population: all randomized participants who received at least one dose of study medication. All adverse events (AEs) were summarized by system organ class and preferred term. All treatment emergent AEs and serious adverse events (SAEs) were collected and reported. A participant with multiple occurrences of AEs counted once in AE category. A participant with multiple AEs within a primary system organ class was counted once in system organ class.
|
2.7%
1/37 • Number of events 1 • From signing of the informed consent form until 5 days after last administration of study drug (up to Day 13)
Safety population: all randomized participants who received at least one dose of study medication. All adverse events (AEs) were summarized by system organ class and preferred term. All treatment emergent AEs and serious adverse events (SAEs) were collected and reported. A participant with multiple occurrences of AEs counted once in AE category. A participant with multiple AEs within a primary system organ class was counted once in system organ class.
|
|
Gastrointestinal disorders
Dyspepsia
|
2.8%
1/36 • Number of events 1 • From signing of the informed consent form until 5 days after last administration of study drug (up to Day 13)
Safety population: all randomized participants who received at least one dose of study medication. All adverse events (AEs) were summarized by system organ class and preferred term. All treatment emergent AEs and serious adverse events (SAEs) were collected and reported. A participant with multiple occurrences of AEs counted once in AE category. A participant with multiple AEs within a primary system organ class was counted once in system organ class.
|
2.9%
1/35 • Number of events 1 • From signing of the informed consent form until 5 days after last administration of study drug (up to Day 13)
Safety population: all randomized participants who received at least one dose of study medication. All adverse events (AEs) were summarized by system organ class and preferred term. All treatment emergent AEs and serious adverse events (SAEs) were collected and reported. A participant with multiple occurrences of AEs counted once in AE category. A participant with multiple AEs within a primary system organ class was counted once in system organ class.
|
2.7%
1/37 • Number of events 2 • From signing of the informed consent form until 5 days after last administration of study drug (up to Day 13)
Safety population: all randomized participants who received at least one dose of study medication. All adverse events (AEs) were summarized by system organ class and preferred term. All treatment emergent AEs and serious adverse events (SAEs) were collected and reported. A participant with multiple occurrences of AEs counted once in AE category. A participant with multiple AEs within a primary system organ class was counted once in system organ class.
|
|
Gastrointestinal disorders
Gingival oedema
|
0.00%
0/36 • From signing of the informed consent form until 5 days after last administration of study drug (up to Day 13)
Safety population: all randomized participants who received at least one dose of study medication. All adverse events (AEs) were summarized by system organ class and preferred term. All treatment emergent AEs and serious adverse events (SAEs) were collected and reported. A participant with multiple occurrences of AEs counted once in AE category. A participant with multiple AEs within a primary system organ class was counted once in system organ class.
|
2.9%
1/35 • Number of events 1 • From signing of the informed consent form until 5 days after last administration of study drug (up to Day 13)
Safety population: all randomized participants who received at least one dose of study medication. All adverse events (AEs) were summarized by system organ class and preferred term. All treatment emergent AEs and serious adverse events (SAEs) were collected and reported. A participant with multiple occurrences of AEs counted once in AE category. A participant with multiple AEs within a primary system organ class was counted once in system organ class.
|
2.7%
1/37 • Number of events 1 • From signing of the informed consent form until 5 days after last administration of study drug (up to Day 13)
Safety population: all randomized participants who received at least one dose of study medication. All adverse events (AEs) were summarized by system organ class and preferred term. All treatment emergent AEs and serious adverse events (SAEs) were collected and reported. A participant with multiple occurrences of AEs counted once in AE category. A participant with multiple AEs within a primary system organ class was counted once in system organ class.
|
|
Gastrointestinal disorders
Nausea
|
11.1%
4/36 • Number of events 4 • From signing of the informed consent form until 5 days after last administration of study drug (up to Day 13)
Safety population: all randomized participants who received at least one dose of study medication. All adverse events (AEs) were summarized by system organ class and preferred term. All treatment emergent AEs and serious adverse events (SAEs) were collected and reported. A participant with multiple occurrences of AEs counted once in AE category. A participant with multiple AEs within a primary system organ class was counted once in system organ class.
|
0.00%
0/35 • From signing of the informed consent form until 5 days after last administration of study drug (up to Day 13)
Safety population: all randomized participants who received at least one dose of study medication. All adverse events (AEs) were summarized by system organ class and preferred term. All treatment emergent AEs and serious adverse events (SAEs) were collected and reported. A participant with multiple occurrences of AEs counted once in AE category. A participant with multiple AEs within a primary system organ class was counted once in system organ class.
|
10.8%
4/37 • Number of events 4 • From signing of the informed consent form until 5 days after last administration of study drug (up to Day 13)
Safety population: all randomized participants who received at least one dose of study medication. All adverse events (AEs) were summarized by system organ class and preferred term. All treatment emergent AEs and serious adverse events (SAEs) were collected and reported. A participant with multiple occurrences of AEs counted once in AE category. A participant with multiple AEs within a primary system organ class was counted once in system organ class.
|
|
Gastrointestinal disorders
Oral discomfort
|
2.8%
1/36 • Number of events 1 • From signing of the informed consent form until 5 days after last administration of study drug (up to Day 13)
Safety population: all randomized participants who received at least one dose of study medication. All adverse events (AEs) were summarized by system organ class and preferred term. All treatment emergent AEs and serious adverse events (SAEs) were collected and reported. A participant with multiple occurrences of AEs counted once in AE category. A participant with multiple AEs within a primary system organ class was counted once in system organ class.
|
2.9%
1/35 • Number of events 1 • From signing of the informed consent form until 5 days after last administration of study drug (up to Day 13)
Safety population: all randomized participants who received at least one dose of study medication. All adverse events (AEs) were summarized by system organ class and preferred term. All treatment emergent AEs and serious adverse events (SAEs) were collected and reported. A participant with multiple occurrences of AEs counted once in AE category. A participant with multiple AEs within a primary system organ class was counted once in system organ class.
|
5.4%
2/37 • Number of events 2 • From signing of the informed consent form until 5 days after last administration of study drug (up to Day 13)
Safety population: all randomized participants who received at least one dose of study medication. All adverse events (AEs) were summarized by system organ class and preferred term. All treatment emergent AEs and serious adverse events (SAEs) were collected and reported. A participant with multiple occurrences of AEs counted once in AE category. A participant with multiple AEs within a primary system organ class was counted once in system organ class.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/36 • From signing of the informed consent form until 5 days after last administration of study drug (up to Day 13)
Safety population: all randomized participants who received at least one dose of study medication. All adverse events (AEs) were summarized by system organ class and preferred term. All treatment emergent AEs and serious adverse events (SAEs) were collected and reported. A participant with multiple occurrences of AEs counted once in AE category. A participant with multiple AEs within a primary system organ class was counted once in system organ class.
|
2.9%
1/35 • Number of events 1 • From signing of the informed consent form until 5 days after last administration of study drug (up to Day 13)
Safety population: all randomized participants who received at least one dose of study medication. All adverse events (AEs) were summarized by system organ class and preferred term. All treatment emergent AEs and serious adverse events (SAEs) were collected and reported. A participant with multiple occurrences of AEs counted once in AE category. A participant with multiple AEs within a primary system organ class was counted once in system organ class.
|
2.7%
1/37 • Number of events 1 • From signing of the informed consent form until 5 days after last administration of study drug (up to Day 13)
Safety population: all randomized participants who received at least one dose of study medication. All adverse events (AEs) were summarized by system organ class and preferred term. All treatment emergent AEs and serious adverse events (SAEs) were collected and reported. A participant with multiple occurrences of AEs counted once in AE category. A participant with multiple AEs within a primary system organ class was counted once in system organ class.
|
|
General disorders
Chest discomfort
|
2.8%
1/36 • Number of events 1 • From signing of the informed consent form until 5 days after last administration of study drug (up to Day 13)
Safety population: all randomized participants who received at least one dose of study medication. All adverse events (AEs) were summarized by system organ class and preferred term. All treatment emergent AEs and serious adverse events (SAEs) were collected and reported. A participant with multiple occurrences of AEs counted once in AE category. A participant with multiple AEs within a primary system organ class was counted once in system organ class.
|
0.00%
0/35 • From signing of the informed consent form until 5 days after last administration of study drug (up to Day 13)
Safety population: all randomized participants who received at least one dose of study medication. All adverse events (AEs) were summarized by system organ class and preferred term. All treatment emergent AEs and serious adverse events (SAEs) were collected and reported. A participant with multiple occurrences of AEs counted once in AE category. A participant with multiple AEs within a primary system organ class was counted once in system organ class.
|
2.7%
1/37 • Number of events 1 • From signing of the informed consent form until 5 days after last administration of study drug (up to Day 13)
Safety population: all randomized participants who received at least one dose of study medication. All adverse events (AEs) were summarized by system organ class and preferred term. All treatment emergent AEs and serious adverse events (SAEs) were collected and reported. A participant with multiple occurrences of AEs counted once in AE category. A participant with multiple AEs within a primary system organ class was counted once in system organ class.
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
2.8%
1/36 • Number of events 1 • From signing of the informed consent form until 5 days after last administration of study drug (up to Day 13)
Safety population: all randomized participants who received at least one dose of study medication. All adverse events (AEs) were summarized by system organ class and preferred term. All treatment emergent AEs and serious adverse events (SAEs) were collected and reported. A participant with multiple occurrences of AEs counted once in AE category. A participant with multiple AEs within a primary system organ class was counted once in system organ class.
|
0.00%
0/35 • From signing of the informed consent form until 5 days after last administration of study drug (up to Day 13)
Safety population: all randomized participants who received at least one dose of study medication. All adverse events (AEs) were summarized by system organ class and preferred term. All treatment emergent AEs and serious adverse events (SAEs) were collected and reported. A participant with multiple occurrences of AEs counted once in AE category. A participant with multiple AEs within a primary system organ class was counted once in system organ class.
|
2.7%
1/37 • Number of events 1 • From signing of the informed consent form until 5 days after last administration of study drug (up to Day 13)
Safety population: all randomized participants who received at least one dose of study medication. All adverse events (AEs) were summarized by system organ class and preferred term. All treatment emergent AEs and serious adverse events (SAEs) were collected and reported. A participant with multiple occurrences of AEs counted once in AE category. A participant with multiple AEs within a primary system organ class was counted once in system organ class.
|
|
Nervous system disorders
Dizziness
|
2.8%
1/36 • Number of events 1 • From signing of the informed consent form until 5 days after last administration of study drug (up to Day 13)
Safety population: all randomized participants who received at least one dose of study medication. All adverse events (AEs) were summarized by system organ class and preferred term. All treatment emergent AEs and serious adverse events (SAEs) were collected and reported. A participant with multiple occurrences of AEs counted once in AE category. A participant with multiple AEs within a primary system organ class was counted once in system organ class.
|
2.9%
1/35 • Number of events 1 • From signing of the informed consent form until 5 days after last administration of study drug (up to Day 13)
Safety population: all randomized participants who received at least one dose of study medication. All adverse events (AEs) were summarized by system organ class and preferred term. All treatment emergent AEs and serious adverse events (SAEs) were collected and reported. A participant with multiple occurrences of AEs counted once in AE category. A participant with multiple AEs within a primary system organ class was counted once in system organ class.
|
5.4%
2/37 • Number of events 2 • From signing of the informed consent form until 5 days after last administration of study drug (up to Day 13)
Safety population: all randomized participants who received at least one dose of study medication. All adverse events (AEs) were summarized by system organ class and preferred term. All treatment emergent AEs and serious adverse events (SAEs) were collected and reported. A participant with multiple occurrences of AEs counted once in AE category. A participant with multiple AEs within a primary system organ class was counted once in system organ class.
|
|
Nervous system disorders
Headache
|
2.8%
1/36 • Number of events 1 • From signing of the informed consent form until 5 days after last administration of study drug (up to Day 13)
Safety population: all randomized participants who received at least one dose of study medication. All adverse events (AEs) were summarized by system organ class and preferred term. All treatment emergent AEs and serious adverse events (SAEs) were collected and reported. A participant with multiple occurrences of AEs counted once in AE category. A participant with multiple AEs within a primary system organ class was counted once in system organ class.
|
0.00%
0/35 • From signing of the informed consent form until 5 days after last administration of study drug (up to Day 13)
Safety population: all randomized participants who received at least one dose of study medication. All adverse events (AEs) were summarized by system organ class and preferred term. All treatment emergent AEs and serious adverse events (SAEs) were collected and reported. A participant with multiple occurrences of AEs counted once in AE category. A participant with multiple AEs within a primary system organ class was counted once in system organ class.
|
2.7%
1/37 • Number of events 1 • From signing of the informed consent form until 5 days after last administration of study drug (up to Day 13)
Safety population: all randomized participants who received at least one dose of study medication. All adverse events (AEs) were summarized by system organ class and preferred term. All treatment emergent AEs and serious adverse events (SAEs) were collected and reported. A participant with multiple occurrences of AEs counted once in AE category. A participant with multiple AEs within a primary system organ class was counted once in system organ class.
|
|
Nervous system disorders
Paraesthesia
|
2.8%
1/36 • Number of events 1 • From signing of the informed consent form until 5 days after last administration of study drug (up to Day 13)
Safety population: all randomized participants who received at least one dose of study medication. All adverse events (AEs) were summarized by system organ class and preferred term. All treatment emergent AEs and serious adverse events (SAEs) were collected and reported. A participant with multiple occurrences of AEs counted once in AE category. A participant with multiple AEs within a primary system organ class was counted once in system organ class.
|
0.00%
0/35 • From signing of the informed consent form until 5 days after last administration of study drug (up to Day 13)
Safety population: all randomized participants who received at least one dose of study medication. All adverse events (AEs) were summarized by system organ class and preferred term. All treatment emergent AEs and serious adverse events (SAEs) were collected and reported. A participant with multiple occurrences of AEs counted once in AE category. A participant with multiple AEs within a primary system organ class was counted once in system organ class.
|
2.7%
1/37 • Number of events 1 • From signing of the informed consent form until 5 days after last administration of study drug (up to Day 13)
Safety population: all randomized participants who received at least one dose of study medication. All adverse events (AEs) were summarized by system organ class and preferred term. All treatment emergent AEs and serious adverse events (SAEs) were collected and reported. A participant with multiple occurrences of AEs counted once in AE category. A participant with multiple AEs within a primary system organ class was counted once in system organ class.
|
|
Psychiatric disorders
Anxiety
|
2.8%
1/36 • Number of events 1 • From signing of the informed consent form until 5 days after last administration of study drug (up to Day 13)
Safety population: all randomized participants who received at least one dose of study medication. All adverse events (AEs) were summarized by system organ class and preferred term. All treatment emergent AEs and serious adverse events (SAEs) were collected and reported. A participant with multiple occurrences of AEs counted once in AE category. A participant with multiple AEs within a primary system organ class was counted once in system organ class.
|
0.00%
0/35 • From signing of the informed consent form until 5 days after last administration of study drug (up to Day 13)
Safety population: all randomized participants who received at least one dose of study medication. All adverse events (AEs) were summarized by system organ class and preferred term. All treatment emergent AEs and serious adverse events (SAEs) were collected and reported. A participant with multiple occurrences of AEs counted once in AE category. A participant with multiple AEs within a primary system organ class was counted once in system organ class.
|
2.7%
1/37 • Number of events 1 • From signing of the informed consent form until 5 days after last administration of study drug (up to Day 13)
Safety population: all randomized participants who received at least one dose of study medication. All adverse events (AEs) were summarized by system organ class and preferred term. All treatment emergent AEs and serious adverse events (SAEs) were collected and reported. A participant with multiple occurrences of AEs counted once in AE category. A participant with multiple AEs within a primary system organ class was counted once in system organ class.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
2.8%
1/36 • Number of events 1 • From signing of the informed consent form until 5 days after last administration of study drug (up to Day 13)
Safety population: all randomized participants who received at least one dose of study medication. All adverse events (AEs) were summarized by system organ class and preferred term. All treatment emergent AEs and serious adverse events (SAEs) were collected and reported. A participant with multiple occurrences of AEs counted once in AE category. A participant with multiple AEs within a primary system organ class was counted once in system organ class.
|
2.9%
1/35 • Number of events 1 • From signing of the informed consent form until 5 days after last administration of study drug (up to Day 13)
Safety population: all randomized participants who received at least one dose of study medication. All adverse events (AEs) were summarized by system organ class and preferred term. All treatment emergent AEs and serious adverse events (SAEs) were collected and reported. A participant with multiple occurrences of AEs counted once in AE category. A participant with multiple AEs within a primary system organ class was counted once in system organ class.
|
5.4%
2/37 • Number of events 2 • From signing of the informed consent form until 5 days after last administration of study drug (up to Day 13)
Safety population: all randomized participants who received at least one dose of study medication. All adverse events (AEs) were summarized by system organ class and preferred term. All treatment emergent AEs and serious adverse events (SAEs) were collected and reported. A participant with multiple occurrences of AEs counted once in AE category. A participant with multiple AEs within a primary system organ class was counted once in system organ class.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
2.8%
1/36 • Number of events 1 • From signing of the informed consent form until 5 days after last administration of study drug (up to Day 13)
Safety population: all randomized participants who received at least one dose of study medication. All adverse events (AEs) were summarized by system organ class and preferred term. All treatment emergent AEs and serious adverse events (SAEs) were collected and reported. A participant with multiple occurrences of AEs counted once in AE category. A participant with multiple AEs within a primary system organ class was counted once in system organ class.
|
0.00%
0/35 • From signing of the informed consent form until 5 days after last administration of study drug (up to Day 13)
Safety population: all randomized participants who received at least one dose of study medication. All adverse events (AEs) were summarized by system organ class and preferred term. All treatment emergent AEs and serious adverse events (SAEs) were collected and reported. A participant with multiple occurrences of AEs counted once in AE category. A participant with multiple AEs within a primary system organ class was counted once in system organ class.
|
2.7%
1/37 • Number of events 1 • From signing of the informed consent form until 5 days after last administration of study drug (up to Day 13)
Safety population: all randomized participants who received at least one dose of study medication. All adverse events (AEs) were summarized by system organ class and preferred term. All treatment emergent AEs and serious adverse events (SAEs) were collected and reported. A participant with multiple occurrences of AEs counted once in AE category. A participant with multiple AEs within a primary system organ class was counted once in system organ class.
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
13.9%
5/36 • Number of events 5 • From signing of the informed consent form until 5 days after last administration of study drug (up to Day 13)
Safety population: all randomized participants who received at least one dose of study medication. All adverse events (AEs) were summarized by system organ class and preferred term. All treatment emergent AEs and serious adverse events (SAEs) were collected and reported. A participant with multiple occurrences of AEs counted once in AE category. A participant with multiple AEs within a primary system organ class was counted once in system organ class.
|
5.7%
2/35 • Number of events 2 • From signing of the informed consent form until 5 days after last administration of study drug (up to Day 13)
Safety population: all randomized participants who received at least one dose of study medication. All adverse events (AEs) were summarized by system organ class and preferred term. All treatment emergent AEs and serious adverse events (SAEs) were collected and reported. A participant with multiple occurrences of AEs counted once in AE category. A participant with multiple AEs within a primary system organ class was counted once in system organ class.
|
16.2%
6/37 • Number of events 7 • From signing of the informed consent form until 5 days after last administration of study drug (up to Day 13)
Safety population: all randomized participants who received at least one dose of study medication. All adverse events (AEs) were summarized by system organ class and preferred term. All treatment emergent AEs and serious adverse events (SAEs) were collected and reported. A participant with multiple occurrences of AEs counted once in AE category. A participant with multiple AEs within a primary system organ class was counted once in system organ class.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/36 • From signing of the informed consent form until 5 days after last administration of study drug (up to Day 13)
Safety population: all randomized participants who received at least one dose of study medication. All adverse events (AEs) were summarized by system organ class and preferred term. All treatment emergent AEs and serious adverse events (SAEs) were collected and reported. A participant with multiple occurrences of AEs counted once in AE category. A participant with multiple AEs within a primary system organ class was counted once in system organ class.
|
2.9%
1/35 • Number of events 2 • From signing of the informed consent form until 5 days after last administration of study drug (up to Day 13)
Safety population: all randomized participants who received at least one dose of study medication. All adverse events (AEs) were summarized by system organ class and preferred term. All treatment emergent AEs and serious adverse events (SAEs) were collected and reported. A participant with multiple occurrences of AEs counted once in AE category. A participant with multiple AEs within a primary system organ class was counted once in system organ class.
|
2.7%
1/37 • Number of events 2 • From signing of the informed consent form until 5 days after last administration of study drug (up to Day 13)
Safety population: all randomized participants who received at least one dose of study medication. All adverse events (AEs) were summarized by system organ class and preferred term. All treatment emergent AEs and serious adverse events (SAEs) were collected and reported. A participant with multiple occurrences of AEs counted once in AE category. A participant with multiple AEs within a primary system organ class was counted once in system organ class.
|
Additional Information
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