Trial Outcomes & Findings for A Bioequivalence Study of 21 Milligram (mg) Nicotine Transdermal Patches (NicoDerm CQ, GlaxoSmithKline [GSK] Dungarvan) Compared to the Current Marketed 21 mg Nicotine Transdermal Patches (NicoDerm CQ, Alza) in Healthy Adult Smokers (NCT NCT05024747)
NCT ID: NCT05024747
Last Updated: 2024-03-21
Results Overview
Cmax was the highest observed plasma nicotine concentration of NicoDerm CQ Dungarvan (Test) compared to NicoDerm CQ, Alza (Reference) was reported. Blood samples were collected at indicated time points. Pharmacokinetic analysis of NicoDerm CQ Dungarvan (Test) compared to NicoDerm CQ, Alza (Reference) was conducted using standard non-compartmental analysis. Analysis was performed using a linear mixed effects model fit to the log-transformed pharmacokinetic (PK) variables, as the dependent variable, treatment, and period as fixed effects. Geometric mean and CV of the geometric mean was presented. Comparison data of Test vs Reference was reported based on the baseline adjusted data.in statistical analysis 1.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
22 participants
Primary outcome timeframe
Pre-dose (within 1 hour before dosing), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 18, 20, 24, 25, 26, 27, 28, 30, 32, and 36 hours post-dose in each treatment period
Results posted on
2024-03-21
Participant Flow
The study was conducted at single center in United States from 01 September 2021 to 25 October 2021. A total of 22 participants were enrolled, out of which 21 participants were randomized and received treatment during two treatment periods.
Eligible participants received either NicoDerm CQ patch (GSK Dungarvan) Test or NicoDerm CQ (Alza) Reference for a total duration of 24 hours on Day 1 (Period 1) and Day 5 (Period 2). Same participants had multiple movement within the arms of two sequence levels (Test and reference). So, overall participant data was planned, analyzed and reported to avoid double-counting in disposition and baseline characteristics.
Participant milestones
| Measure |
NicoDerm CQ Dungarvan First, Then NicoDerm CQ Alza
Participants received a single-dose of 21 milligrams (mg) of NicoDerm CQ patch (GSK Dungarvan) Test on Day 1 (Period 1) and NicoDerm CQ (Alza) Reference on Day 5 (Period 2) placed topically under fasted conditions to the upper part of the back for a total duration of 24 hours. Two periods were separated by 24 hours wash-out. The patch that was applied during Period 2 was not applied to the same position as the patch that was applied during Period 1 but on the upper back of the contralateral side of the body.
|
NicoDerm CQ Alza First, Then NicoDerm CQ Dungarvan
Participants received a single-dose of 21 mg of NicoDerm CQ (Alza) Reference on Day 1 (Period 1) and NicoDerm CQ patch (GSK Dungarvan) Test on Day 5 (Period 2) placed topically under fasted conditions to the upper part of the back for a total duration of 24 hours. Two periods were separated by 24 hours wash-out. The patch that was applied during Period 2 was not applied to the same position as the patch that was applied during Period 1 but on the upper back of the contralateral side of the body.
|
|---|---|---|
|
Period 1 (Day 1 to 2)
STARTED
|
11
|
10
|
|
Period 1 (Day 1 to 2)
COMPLETED
|
10
|
5
|
|
Period 1 (Day 1 to 2)
NOT COMPLETED
|
1
|
5
|
|
Wash-out (Day 3)
STARTED
|
10
|
5
|
|
Wash-out (Day 3)
COMPLETED
|
10
|
5
|
|
Wash-out (Day 3)
NOT COMPLETED
|
0
|
0
|
|
Period 2 (Day 4 to 6)
STARTED
|
10
|
5
|
|
Period 2 (Day 4 to 6)
COMPLETED
|
10
|
5
|
|
Period 2 (Day 4 to 6)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
NicoDerm CQ Dungarvan First, Then NicoDerm CQ Alza
Participants received a single-dose of 21 milligrams (mg) of NicoDerm CQ patch (GSK Dungarvan) Test on Day 1 (Period 1) and NicoDerm CQ (Alza) Reference on Day 5 (Period 2) placed topically under fasted conditions to the upper part of the back for a total duration of 24 hours. Two periods were separated by 24 hours wash-out. The patch that was applied during Period 2 was not applied to the same position as the patch that was applied during Period 1 but on the upper back of the contralateral side of the body.
|
NicoDerm CQ Alza First, Then NicoDerm CQ Dungarvan
Participants received a single-dose of 21 mg of NicoDerm CQ (Alza) Reference on Day 1 (Period 1) and NicoDerm CQ patch (GSK Dungarvan) Test on Day 5 (Period 2) placed topically under fasted conditions to the upper part of the back for a total duration of 24 hours. Two periods were separated by 24 hours wash-out. The patch that was applied during Period 2 was not applied to the same position as the patch that was applied during Period 1 but on the upper back of the contralateral side of the body.
|
|---|---|---|
|
Period 1 (Day 1 to 2)
Protocol Violation
|
1
|
3
|
|
Period 1 (Day 1 to 2)
Adverse Event
|
0
|
1
|
|
Period 1 (Day 1 to 2)
Patch fall off or patch is inadvertently removed by the participant
|
0
|
1
|
Baseline Characteristics
A Bioequivalence Study of 21 Milligram (mg) Nicotine Transdermal Patches (NicoDerm CQ, GlaxoSmithKline [GSK] Dungarvan) Compared to the Current Marketed 21 mg Nicotine Transdermal Patches (NicoDerm CQ, Alza) in Healthy Adult Smokers
Baseline characteristics by cohort
| Measure |
All Study Participants
n=21 Participants
Participants received a single-dose of 21 mg of either NicoDerm CQ patch (GSK Dungarvan) Test or NicoDerm CQ (Alza) Reference placed topically under fasted conditions to the upper part of the back for a total duration of 24 hours on Day 1 (Period 1) and Day 5 (Period 2). Two periods were separated by 24 hours wash-out. The patch that was applied during Period 2 was not applied to the same position as the patch that was applied during Period 1 but on the upper back of the contralateral side of the body.
|
|---|---|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
21 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 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
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
17 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
|
|
Age, Continuous
|
39.1 Years
STANDARD_DEVIATION 8.79 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Pre-dose (within 1 hour before dosing), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 18, 20, 24, 25, 26, 27, 28, 30, 32, and 36 hours post-dose in each treatment periodPopulation: The PK population was defined as all randomized participants who completed both periods, and who had no major protocol deviations concerning PK regardless of patch adhesion score.
Cmax was the highest observed plasma nicotine concentration of NicoDerm CQ Dungarvan (Test) compared to NicoDerm CQ, Alza (Reference) was reported. Blood samples were collected at indicated time points. Pharmacokinetic analysis of NicoDerm CQ Dungarvan (Test) compared to NicoDerm CQ, Alza (Reference) was conducted using standard non-compartmental analysis. Analysis was performed using a linear mixed effects model fit to the log-transformed pharmacokinetic (PK) variables, as the dependent variable, treatment, and period as fixed effects. Geometric mean and CV of the geometric mean was presented. Comparison data of Test vs Reference was reported based on the baseline adjusted data.in statistical analysis 1.
Outcome measures
| Measure |
NicoDerm CQ Dungarvan (Test)
n=15 Participants
Participants received a single dose of 21 mg of NicoDerm CQ patch (GSK Dungarvan) Test placed topically under fasted conditions to the upper part of the back for a total duration of 24 hours either on Day 1 (Period 1) or Day 5 (Period 2). Two periods were separated by 24 hours wash-out. The patch that was applied during Period 2 was not applied to the same position as the patch that was applied during Period 1 but on the upper back of the contralateral side of the body.
|
NicoDerm CQ Alza (Reference)
n=15 Participants
Participants received a single dose of 21 mg of NicoDerm CQ (Alza) Reference placed topically under fasted conditions to the upper part of the back for a total duration of 24 hours either on either (Period 1) or Day 5 (Period 2). Two periods were separated by 24 hours wash-out. The patch that was applied during Period 2 was not applied to the same position as the patch that was applied during Period 1 but on the upper back of the contralateral side of the body.
|
|---|---|---|
|
Maximum Observed Plasma Nicotine Concentration (Cmax) of NicoDerm CQ Dungarvan (Test) Compared to NicoDerm CQ, Alza (Reference)
|
23.554 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 20.3
|
24.478 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 22.9
|
PRIMARY outcome
Timeframe: Pre-dose (within 1 hour before dosing), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 18, 20, 24, 25, 26, 27, 28, 30, 32, and 36 hours post-dosePopulation: Analysis was performed using PK population.
Area under the plasma concentration versus time curve from time zero to time t, where t was the time of the last measurable plasma concentration of nicotine, estimated, computed using the linear trapezoidal rule. Blood samples were collected at indicated time points. Pharmacokinetic analysis of NicoDerm CQ Dungarvan (Test) compared to NicoDerm CQ, Alza (Reference) was conducted using standard non-compartmental analysis. Analysis was performed using a linear mixed effects model fit to the log-transformed PK variable, as the dependent variable, treatment, and period as fixed effects. Geometric mean and CV of the geometric mean was presented. Comparison data of Test vs Reference was reported based on the baseline adjusted data.in statistical analysis 1.
Outcome measures
| Measure |
NicoDerm CQ Dungarvan (Test)
n=15 Participants
Participants received a single dose of 21 mg of NicoDerm CQ patch (GSK Dungarvan) Test placed topically under fasted conditions to the upper part of the back for a total duration of 24 hours either on Day 1 (Period 1) or Day 5 (Period 2). Two periods were separated by 24 hours wash-out. The patch that was applied during Period 2 was not applied to the same position as the patch that was applied during Period 1 but on the upper back of the contralateral side of the body.
|
NicoDerm CQ Alza (Reference)
n=15 Participants
Participants received a single dose of 21 mg of NicoDerm CQ (Alza) Reference placed topically under fasted conditions to the upper part of the back for a total duration of 24 hours either on either (Period 1) or Day 5 (Period 2). Two periods were separated by 24 hours wash-out. The patch that was applied during Period 2 was not applied to the same position as the patch that was applied during Period 1 but on the upper back of the contralateral side of the body.
|
|---|---|---|
|
Area Under the Plasma Concentration Versus Time Curve From Time Zero to Time t (AUC [0-t]) of NicoDerm CQ Dungarvan (Test) Compared to NicoDerm CQ, Alza (Reference)
|
529.464 Hour*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 24.6
|
564.085 Hour*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 23.4
|
PRIMARY outcome
Timeframe: Pre-dose (within 1 hour before dosing), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 18, 20, 24, 25, 26, 27, 28, 30, 32, and 36 hours post-dosePopulation: Analysis was performed using PK population.
Area under the plasma concentration versus time curve calculated from time zero to infinity. AUC0-inf = AUC0-t + C(t)/λz. C(t)- Concentration at the last measurable sampling time point and λz- terminal elimination rate constant. Blood samples were collected at indicated time points. Pharmacokinetic analysis of NicoDerm CQ Dungarvan (Test) compared to NicoDerm CQ, Alza (Reference) was conducted using standard non-compartmental analysis. Analysis was performed using a linear mixed effects model fit to the log-transformed PK variable, as the dependent variable, treatment, and period as fixed effects. Geometric mean and CV of the geometric mean was presented. Comparison data of Test vs Reference was reported based on the baseline adjusted data.in statistical analysis 1.
Outcome measures
| Measure |
NicoDerm CQ Dungarvan (Test)
n=15 Participants
Participants received a single dose of 21 mg of NicoDerm CQ patch (GSK Dungarvan) Test placed topically under fasted conditions to the upper part of the back for a total duration of 24 hours either on Day 1 (Period 1) or Day 5 (Period 2). Two periods were separated by 24 hours wash-out. The patch that was applied during Period 2 was not applied to the same position as the patch that was applied during Period 1 but on the upper back of the contralateral side of the body.
|
NicoDerm CQ Alza (Reference)
n=15 Participants
Participants received a single dose of 21 mg of NicoDerm CQ (Alza) Reference placed topically under fasted conditions to the upper part of the back for a total duration of 24 hours either on either (Period 1) or Day 5 (Period 2). Two periods were separated by 24 hours wash-out. The patch that was applied during Period 2 was not applied to the same position as the patch that was applied during Period 1 but on the upper back of the contralateral side of the body.
|
|---|---|---|
|
Area Under the Plasma Concentration Versus Time Curve Calculated From Time Zero to Infinity (AUC [(0-inf]) of NicoDerm CQ Dungarvan (Test) Compared to NicoDerm CQ, Alza (Reference)
|
537.518 h*ng/mL
Geometric Coefficient of Variation 24.9
|
571.211 h*ng/mL
Geometric Coefficient of Variation 24.0
|
SECONDARY outcome
Timeframe: Pre-dose (within 1 hour before dosing), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 18, 20, 24, 25, 26, 27, 28, 30, 32, and 36 hours post-dosePopulation: Analysis was performed using PK population.
Terminal elimination rate constant for plasma nicotine computed as the slope of the regression line of ln (C(t)) on time. The regression should generally involve at least 3 consecutive measurable concentrations that decrease over time. Blood samples were collected at indicated time points. Pharmacokinetic analysis of NicoDerm CQ Dungarvan (Test) and NicoDerm CQ, Alza (Reference) was conducted using standard non-compartmental analysis.
Outcome measures
| Measure |
NicoDerm CQ Dungarvan (Test)
n=15 Participants
Participants received a single dose of 21 mg of NicoDerm CQ patch (GSK Dungarvan) Test placed topically under fasted conditions to the upper part of the back for a total duration of 24 hours either on Day 1 (Period 1) or Day 5 (Period 2). Two periods were separated by 24 hours wash-out. The patch that was applied during Period 2 was not applied to the same position as the patch that was applied during Period 1 but on the upper back of the contralateral side of the body.
|
NicoDerm CQ Alza (Reference)
n=15 Participants
Participants received a single dose of 21 mg of NicoDerm CQ (Alza) Reference placed topically under fasted conditions to the upper part of the back for a total duration of 24 hours either on either (Period 1) or Day 5 (Period 2). Two periods were separated by 24 hours wash-out. The patch that was applied during Period 2 was not applied to the same position as the patch that was applied during Period 1 but on the upper back of the contralateral side of the body.
|
|---|---|---|
|
Terminal Elimination Rate Constant (Lambda z) of NicoDerm CQ Dungarvan (Test) and NicoDerm CQ, Alza (Reference) of Patches
|
0.2141 Per hour
Interval 0.18266 to 0.23855
|
0.2475 Per hour
Interval 0.19543 to 0.2655
|
SECONDARY outcome
Timeframe: Pre-dose (within 1 hour before dosing), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 18, 20, 24, 25, 26, 27, 28, 30, 32, and 36 hours post-dosePopulation: Analysis was performed using PK population.
Time to maximum plasma nicotine concentration of NicoDerm CQ Dungarvan (Test) and NicoDerm CQ, Alza (Reference) patches was reported. Blood samples were collected at indicated time points. Pharmacokinetic analysis of NicoDerm CQ Dungarvan (Test) and NicoDerm CQ, Alza (Reference) patches was conducted using standard non-compartmental analysis.
Outcome measures
| Measure |
NicoDerm CQ Dungarvan (Test)
n=15 Participants
Participants received a single dose of 21 mg of NicoDerm CQ patch (GSK Dungarvan) Test placed topically under fasted conditions to the upper part of the back for a total duration of 24 hours either on Day 1 (Period 1) or Day 5 (Period 2). Two periods were separated by 24 hours wash-out. The patch that was applied during Period 2 was not applied to the same position as the patch that was applied during Period 1 but on the upper back of the contralateral side of the body.
|
NicoDerm CQ Alza (Reference)
n=15 Participants
Participants received a single dose of 21 mg of NicoDerm CQ (Alza) Reference placed topically under fasted conditions to the upper part of the back for a total duration of 24 hours either on either (Period 1) or Day 5 (Period 2). Two periods were separated by 24 hours wash-out. The patch that was applied during Period 2 was not applied to the same position as the patch that was applied during Period 1 but on the upper back of the contralateral side of the body.
|
|---|---|---|
|
Maximum Plasma Nicotine Concentration (Tmax) of NicoDerm CQ Dungarvan (Test) and NicoDerm CQ, Alza (Reference) Patches
|
4.000 Hours
Interval 3.0 to 10.0
|
18.000 Hours
Interval 4.0 to 18.0
|
SECONDARY outcome
Timeframe: Pre-dose (within 1 hour before dosing), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 18, 20, 24, 25, 26, 27, 28, 30, 32, and 36 hours post-dosePopulation: Analysis was performed using PK population.
t1/2 was apparent elimination half-life. The elimination half-life computed as t1/2 = ln(2)/ λz). Blood samples were collected at indicated time points. Pharmacokinetic analysis of NicoDerm CQ Dungarvan (Test) and NicoDerm CQ, Alza (Reference) patches was conducted using standard non-compartmental analysis.
Outcome measures
| Measure |
NicoDerm CQ Dungarvan (Test)
n=15 Participants
Participants received a single dose of 21 mg of NicoDerm CQ patch (GSK Dungarvan) Test placed topically under fasted conditions to the upper part of the back for a total duration of 24 hours either on Day 1 (Period 1) or Day 5 (Period 2). Two periods were separated by 24 hours wash-out. The patch that was applied during Period 2 was not applied to the same position as the patch that was applied during Period 1 but on the upper back of the contralateral side of the body.
|
NicoDerm CQ Alza (Reference)
n=15 Participants
Participants received a single dose of 21 mg of NicoDerm CQ (Alza) Reference placed topically under fasted conditions to the upper part of the back for a total duration of 24 hours either on either (Period 1) or Day 5 (Period 2). Two periods were separated by 24 hours wash-out. The patch that was applied during Period 2 was not applied to the same position as the patch that was applied during Period 1 but on the upper back of the contralateral side of the body.
|
|---|---|---|
|
Elimination Half-Life (t1/2) of NicoDerm CQ Dungarvan (Test) and NicoDerm CQ, Alza (Reference) Patches
|
3.2376 Hours
Interval 2.90566 to 3.79479
|
2.8001 Hours
Interval 2.61074 to 3.54677
|
SECONDARY outcome
Timeframe: At 0, 6, 12, 18 and 24 hours post-dosePopulation: Analysis was performed using safety population. Out of 21 participants, 16 participants who were dosed with NicoDerm CQ Dungarvan (Test) and 20 participants dosed with NicoDerm CQ Alza (Reference).
Adhesion to skin assessed by FDA recommended 0-4 scoring system. The scoring for adhesion of patches was indicated as follows: Score 0 ( Greater than or equal to \[\>=\] 90% Adhered \[essentially no lift off the skin\]), Score 1 (\>= 75% to less than \[\<\] 90% Adhered \[some edges only lifting off the skin\]), Score 2 (\>= 50% to \< 75% Adhered \[less than half of the patch lifting off the skin\]), Score 3 (greater than \[\>\] 0% to \< 50% Adhered but not detached \[more than half of the patch lifting off the skin without falling off\]), and Score 4 (0% adhered \[patched completely detached\]).
Outcome measures
| Measure |
NicoDerm CQ Dungarvan (Test)
n=16 Participants
Participants received a single dose of 21 mg of NicoDerm CQ patch (GSK Dungarvan) Test placed topically under fasted conditions to the upper part of the back for a total duration of 24 hours either on Day 1 (Period 1) or Day 5 (Period 2). Two periods were separated by 24 hours wash-out. The patch that was applied during Period 2 was not applied to the same position as the patch that was applied during Period 1 but on the upper back of the contralateral side of the body.
|
NicoDerm CQ Alza (Reference)
n=20 Participants
Participants received a single dose of 21 mg of NicoDerm CQ (Alza) Reference placed topically under fasted conditions to the upper part of the back for a total duration of 24 hours either on either (Period 1) or Day 5 (Period 2). Two periods were separated by 24 hours wash-out. The patch that was applied during Period 2 was not applied to the same position as the patch that was applied during Period 1 but on the upper back of the contralateral side of the body.
|
|---|---|---|
|
Number of Participants With Adhesion Score of NicoDerm CQ Dungarvan (Test) and NicoDerm CQ, Alza (Reference) Patches
0 hour (Immediately After Patch Application): At Score 0
|
16 Participants
|
20 Participants
|
|
Number of Participants With Adhesion Score of NicoDerm CQ Dungarvan (Test) and NicoDerm CQ, Alza (Reference) Patches
0 hour (Immediately After Patch Application): At Score 1
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adhesion Score of NicoDerm CQ Dungarvan (Test) and NicoDerm CQ, Alza (Reference) Patches
0 hour (Immediately After Patch Application): At Score 2
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adhesion Score of NicoDerm CQ Dungarvan (Test) and NicoDerm CQ, Alza (Reference) Patches
0 hour (Immediately After Patch Application): At Score 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adhesion Score of NicoDerm CQ Dungarvan (Test) and NicoDerm CQ, Alza (Reference) Patches
0 hour (Immediately After Patch Application): At Score 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adhesion Score of NicoDerm CQ Dungarvan (Test) and NicoDerm CQ, Alza (Reference) Patches
6 Hours After Patch Application: At Score 0
|
11 Participants
|
14 Participants
|
|
Number of Participants With Adhesion Score of NicoDerm CQ Dungarvan (Test) and NicoDerm CQ, Alza (Reference) Patches
6 Hours After Patch Application: At Score 1
|
5 Participants
|
6 Participants
|
|
Number of Participants With Adhesion Score of NicoDerm CQ Dungarvan (Test) and NicoDerm CQ, Alza (Reference) Patches
6 Hours After Patch Application: At Score 2
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adhesion Score of NicoDerm CQ Dungarvan (Test) and NicoDerm CQ, Alza (Reference) Patches
6 Hours After Patch Application: At Score 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adhesion Score of NicoDerm CQ Dungarvan (Test) and NicoDerm CQ, Alza (Reference) Patches
6 Hours After Patch Application: At Score 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adhesion Score of NicoDerm CQ Dungarvan (Test) and NicoDerm CQ, Alza (Reference) Patches
12 Hours After Patch Application: At Score 0
|
5 Participants
|
10 Participants
|
|
Number of Participants With Adhesion Score of NicoDerm CQ Dungarvan (Test) and NicoDerm CQ, Alza (Reference) Patches
12 Hours After Patch Application: At Score 1
|
11 Participants
|
10 Participants
|
|
Number of Participants With Adhesion Score of NicoDerm CQ Dungarvan (Test) and NicoDerm CQ, Alza (Reference) Patches
12 Hours After Patch Application: At Score 2
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adhesion Score of NicoDerm CQ Dungarvan (Test) and NicoDerm CQ, Alza (Reference) Patches
12 Hours After Patch Application: At Score 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adhesion Score of NicoDerm CQ Dungarvan (Test) and NicoDerm CQ, Alza (Reference) Patches
12 Hours After Patch Application: At Score 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adhesion Score of NicoDerm CQ Dungarvan (Test) and NicoDerm CQ, Alza (Reference) Patches
18 Hours After Patch Application: At Score 0
|
4 Participants
|
6 Participants
|
|
Number of Participants With Adhesion Score of NicoDerm CQ Dungarvan (Test) and NicoDerm CQ, Alza (Reference) Patches
18 Hours After Patch Application: At Score 1
|
12 Participants
|
13 Participants
|
|
Number of Participants With Adhesion Score of NicoDerm CQ Dungarvan (Test) and NicoDerm CQ, Alza (Reference) Patches
18 Hours After Patch Application: At Score 2
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adhesion Score of NicoDerm CQ Dungarvan (Test) and NicoDerm CQ, Alza (Reference) Patches
18 Hours After Patch Application: At Score 3
|
0 Participants
|
1 Participants
|
|
Number of Participants With Adhesion Score of NicoDerm CQ Dungarvan (Test) and NicoDerm CQ, Alza (Reference) Patches
18 Hours After Patch Application: At Score 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adhesion Score of NicoDerm CQ Dungarvan (Test) and NicoDerm CQ, Alza (Reference) Patches
24 Hours After Patch Application: At Score 0
|
2 Participants
|
5 Participants
|
|
Number of Participants With Adhesion Score of NicoDerm CQ Dungarvan (Test) and NicoDerm CQ, Alza (Reference) Patches
24 Hours After Patch Application: At Score 1
|
14 Participants
|
14 Participants
|
|
Number of Participants With Adhesion Score of NicoDerm CQ Dungarvan (Test) and NicoDerm CQ, Alza (Reference) Patches
24 Hours After Patch Application: At Score 2
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adhesion Score of NicoDerm CQ Dungarvan (Test) and NicoDerm CQ, Alza (Reference) Patches
24 Hours After Patch Application: At Score 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adhesion Score of NicoDerm CQ Dungarvan (Test) and NicoDerm CQ, Alza (Reference) Patches
24 Hours After Patch Application: At Score 4
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: From start of study drug administration up to end of study visit (up to Day 6)Population: Analysis was performed using safety population. Out of 21 participants, 16 participants who were dosed with NicoDerm CQ Dungarvan (Test) and 20 participants dosed with NicoDerm CQ Alza (Reference).
TEAEs were defined as any adverse events (AEs) that first occurred on or after the date and time of patch administration. Any AE that first occurred pre-dose but worsened in severity after the first patch administration was also considered a TEAE. An SAE was any untoward medical occurrence that at any dose met one, more of the following criteria: results in death, life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent, significant disability/incapacity, a congenital abnormality/birth defect, an important medical event. A TEAE was any event emerging or manifesting at or after the initiation of treatment with an IP or medicinal product or any existing event that worsens in either intensity or frequency following exposure to the IP or medicinal product. Number of Participants with TEAEs and serious TEAEs were reported.
Outcome measures
| Measure |
NicoDerm CQ Dungarvan (Test)
n=16 Participants
Participants received a single dose of 21 mg of NicoDerm CQ patch (GSK Dungarvan) Test placed topically under fasted conditions to the upper part of the back for a total duration of 24 hours either on Day 1 (Period 1) or Day 5 (Period 2). Two periods were separated by 24 hours wash-out. The patch that was applied during Period 2 was not applied to the same position as the patch that was applied during Period 1 but on the upper back of the contralateral side of the body.
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NicoDerm CQ Alza (Reference)
n=20 Participants
Participants received a single dose of 21 mg of NicoDerm CQ (Alza) Reference placed topically under fasted conditions to the upper part of the back for a total duration of 24 hours either on either (Period 1) or Day 5 (Period 2). Two periods were separated by 24 hours wash-out. The patch that was applied during Period 2 was not applied to the same position as the patch that was applied during Period 1 but on the upper back of the contralateral side of the body.
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Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs (TEAEs)
Participants with TEAEs
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7 Participants
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11 Participants
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Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs (TEAEs)
Participants with Serious TEAEs
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0 Participants
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0 Participants
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Adverse Events
NicoDerm CQ Dungarvan (Test)
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
NicoDerm CQ Alza (Reference)
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
NicoDerm CQ Dungarvan (Test)
n=16 participants at risk
Participants received a single dose of 21 mg of NicoDerm CQ patch (GSK Dungarvan) Test placed topically under fasted conditions to the upper part of the back for a total duration of 24 hours either on Day 1 (Period 1) or Day 5 (Period 2). Two periods were separated by 24 hours wash-out. The patch that was applied during Period 2 was not applied to the same position as the patch that was applied during Period 1 but on the upper back of the contralateral side of the body.
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NicoDerm CQ Alza (Reference)
n=20 participants at risk
Participants received a single dose of 21 mg of NicoDerm CQ (Alza) Reference placed topically under fasted conditions to the upper part of the back for a total duration of 24 hours either on either (Period 1) or Day 5 (Period 2). Two periods were separated by 24 hours wash-out. The patch that was applied during Period 2 was not applied to the same position as the patch that was applied during Period 1 but on the upper back of the contralateral side of the body.
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|---|---|---|
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Nervous system disorders
Dizziness
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12.5%
2/16 • Number of events 4 • From start of study drug administration up to end of study visit (up to Day 6)
Analysis was performed using safety population. Out of 21 participants, 16 participants who were dosed with NicoDerm CQ Dungarvan (Test) and 20 participants dosed with NicoDerm CQ Alza (Reference).
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20.0%
4/20 • Number of events 5 • From start of study drug administration up to end of study visit (up to Day 6)
Analysis was performed using safety population. Out of 21 participants, 16 participants who were dosed with NicoDerm CQ Dungarvan (Test) and 20 participants dosed with NicoDerm CQ Alza (Reference).
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Nervous system disorders
Headache
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6.2%
1/16 • Number of events 1 • From start of study drug administration up to end of study visit (up to Day 6)
Analysis was performed using safety population. Out of 21 participants, 16 participants who were dosed with NicoDerm CQ Dungarvan (Test) and 20 participants dosed with NicoDerm CQ Alza (Reference).
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5.0%
1/20 • Number of events 1 • From start of study drug administration up to end of study visit (up to Day 6)
Analysis was performed using safety population. Out of 21 participants, 16 participants who were dosed with NicoDerm CQ Dungarvan (Test) and 20 participants dosed with NicoDerm CQ Alza (Reference).
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Nervous system disorders
Syncope
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0.00%
0/16 • From start of study drug administration up to end of study visit (up to Day 6)
Analysis was performed using safety population. Out of 21 participants, 16 participants who were dosed with NicoDerm CQ Dungarvan (Test) and 20 participants dosed with NicoDerm CQ Alza (Reference).
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5.0%
1/20 • Number of events 1 • From start of study drug administration up to end of study visit (up to Day 6)
Analysis was performed using safety population. Out of 21 participants, 16 participants who were dosed with NicoDerm CQ Dungarvan (Test) and 20 participants dosed with NicoDerm CQ Alza (Reference).
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General disorders
Application site pruritus
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37.5%
6/16 • Number of events 6 • From start of study drug administration up to end of study visit (up to Day 6)
Analysis was performed using safety population. Out of 21 participants, 16 participants who were dosed with NicoDerm CQ Dungarvan (Test) and 20 participants dosed with NicoDerm CQ Alza (Reference).
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10.0%
2/20 • Number of events 2 • From start of study drug administration up to end of study visit (up to Day 6)
Analysis was performed using safety population. Out of 21 participants, 16 participants who were dosed with NicoDerm CQ Dungarvan (Test) and 20 participants dosed with NicoDerm CQ Alza (Reference).
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General disorders
Chills
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6.2%
1/16 • Number of events 1 • From start of study drug administration up to end of study visit (up to Day 6)
Analysis was performed using safety population. Out of 21 participants, 16 participants who were dosed with NicoDerm CQ Dungarvan (Test) and 20 participants dosed with NicoDerm CQ Alza (Reference).
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0.00%
0/20 • From start of study drug administration up to end of study visit (up to Day 6)
Analysis was performed using safety population. Out of 21 participants, 16 participants who were dosed with NicoDerm CQ Dungarvan (Test) and 20 participants dosed with NicoDerm CQ Alza (Reference).
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Gastrointestinal disorders
Nausea
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12.5%
2/16 • Number of events 2 • From start of study drug administration up to end of study visit (up to Day 6)
Analysis was performed using safety population. Out of 21 participants, 16 participants who were dosed with NicoDerm CQ Dungarvan (Test) and 20 participants dosed with NicoDerm CQ Alza (Reference).
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5.0%
1/20 • Number of events 1 • From start of study drug administration up to end of study visit (up to Day 6)
Analysis was performed using safety population. Out of 21 participants, 16 participants who were dosed with NicoDerm CQ Dungarvan (Test) and 20 participants dosed with NicoDerm CQ Alza (Reference).
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Gastrointestinal disorders
Abdominal pain
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6.2%
1/16 • Number of events 1 • From start of study drug administration up to end of study visit (up to Day 6)
Analysis was performed using safety population. Out of 21 participants, 16 participants who were dosed with NicoDerm CQ Dungarvan (Test) and 20 participants dosed with NicoDerm CQ Alza (Reference).
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0.00%
0/20 • From start of study drug administration up to end of study visit (up to Day 6)
Analysis was performed using safety population. Out of 21 participants, 16 participants who were dosed with NicoDerm CQ Dungarvan (Test) and 20 participants dosed with NicoDerm CQ Alza (Reference).
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Gastrointestinal disorders
Dry mouth
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0.00%
0/16 • From start of study drug administration up to end of study visit (up to Day 6)
Analysis was performed using safety population. Out of 21 participants, 16 participants who were dosed with NicoDerm CQ Dungarvan (Test) and 20 participants dosed with NicoDerm CQ Alza (Reference).
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5.0%
1/20 • Number of events 1 • From start of study drug administration up to end of study visit (up to Day 6)
Analysis was performed using safety population. Out of 21 participants, 16 participants who were dosed with NicoDerm CQ Dungarvan (Test) and 20 participants dosed with NicoDerm CQ Alza (Reference).
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Gastrointestinal disorders
Vomiting
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0.00%
0/16 • From start of study drug administration up to end of study visit (up to Day 6)
Analysis was performed using safety population. Out of 21 participants, 16 participants who were dosed with NicoDerm CQ Dungarvan (Test) and 20 participants dosed with NicoDerm CQ Alza (Reference).
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5.0%
1/20 • Number of events 1 • From start of study drug administration up to end of study visit (up to Day 6)
Analysis was performed using safety population. Out of 21 participants, 16 participants who were dosed with NicoDerm CQ Dungarvan (Test) and 20 participants dosed with NicoDerm CQ Alza (Reference).
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Investigations
Haematocrit increased
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0.00%
0/16 • From start of study drug administration up to end of study visit (up to Day 6)
Analysis was performed using safety population. Out of 21 participants, 16 participants who were dosed with NicoDerm CQ Dungarvan (Test) and 20 participants dosed with NicoDerm CQ Alza (Reference).
|
5.0%
1/20 • Number of events 1 • From start of study drug administration up to end of study visit (up to Day 6)
Analysis was performed using safety population. Out of 21 participants, 16 participants who were dosed with NicoDerm CQ Dungarvan (Test) and 20 participants dosed with NicoDerm CQ Alza (Reference).
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Investigations
Haemoglobin increased
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0.00%
0/16 • From start of study drug administration up to end of study visit (up to Day 6)
Analysis was performed using safety population. Out of 21 participants, 16 participants who were dosed with NicoDerm CQ Dungarvan (Test) and 20 participants dosed with NicoDerm CQ Alza (Reference).
|
5.0%
1/20 • Number of events 1 • From start of study drug administration up to end of study visit (up to Day 6)
Analysis was performed using safety population. Out of 21 participants, 16 participants who were dosed with NicoDerm CQ Dungarvan (Test) and 20 participants dosed with NicoDerm CQ Alza (Reference).
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Investigations
Neutrophil count increased
|
0.00%
0/16 • From start of study drug administration up to end of study visit (up to Day 6)
Analysis was performed using safety population. Out of 21 participants, 16 participants who were dosed with NicoDerm CQ Dungarvan (Test) and 20 participants dosed with NicoDerm CQ Alza (Reference).
|
5.0%
1/20 • Number of events 1 • From start of study drug administration up to end of study visit (up to Day 6)
Analysis was performed using safety population. Out of 21 participants, 16 participants who were dosed with NicoDerm CQ Dungarvan (Test) and 20 participants dosed with NicoDerm CQ Alza (Reference).
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Investigations
Platelet count increased
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0.00%
0/16 • From start of study drug administration up to end of study visit (up to Day 6)
Analysis was performed using safety population. Out of 21 participants, 16 participants who were dosed with NicoDerm CQ Dungarvan (Test) and 20 participants dosed with NicoDerm CQ Alza (Reference).
|
5.0%
1/20 • Number of events 1 • From start of study drug administration up to end of study visit (up to Day 6)
Analysis was performed using safety population. Out of 21 participants, 16 participants who were dosed with NicoDerm CQ Dungarvan (Test) and 20 participants dosed with NicoDerm CQ Alza (Reference).
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Investigations
Red blood cell count increased
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0.00%
0/16 • From start of study drug administration up to end of study visit (up to Day 6)
Analysis was performed using safety population. Out of 21 participants, 16 participants who were dosed with NicoDerm CQ Dungarvan (Test) and 20 participants dosed with NicoDerm CQ Alza (Reference).
|
5.0%
1/20 • Number of events 1 • From start of study drug administration up to end of study visit (up to Day 6)
Analysis was performed using safety population. Out of 21 participants, 16 participants who were dosed with NicoDerm CQ Dungarvan (Test) and 20 participants dosed with NicoDerm CQ Alza (Reference).
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Investigations
White blood cell count increased
|
0.00%
0/16 • From start of study drug administration up to end of study visit (up to Day 6)
Analysis was performed using safety population. Out of 21 participants, 16 participants who were dosed with NicoDerm CQ Dungarvan (Test) and 20 participants dosed with NicoDerm CQ Alza (Reference).
|
5.0%
1/20 • Number of events 1 • From start of study drug administration up to end of study visit (up to Day 6)
Analysis was performed using safety population. Out of 21 participants, 16 participants who were dosed with NicoDerm CQ Dungarvan (Test) and 20 participants dosed with NicoDerm CQ Alza (Reference).
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Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/16 • From start of study drug administration up to end of study visit (up to Day 6)
Analysis was performed using safety population. Out of 21 participants, 16 participants who were dosed with NicoDerm CQ Dungarvan (Test) and 20 participants dosed with NicoDerm CQ Alza (Reference).
|
10.0%
2/20 • Number of events 2 • From start of study drug administration up to end of study visit (up to Day 6)
Analysis was performed using safety population. Out of 21 participants, 16 participants who were dosed with NicoDerm CQ Dungarvan (Test) and 20 participants dosed with NicoDerm CQ Alza (Reference).
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Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/16 • From start of study drug administration up to end of study visit (up to Day 6)
Analysis was performed using safety population. Out of 21 participants, 16 participants who were dosed with NicoDerm CQ Dungarvan (Test) and 20 participants dosed with NicoDerm CQ Alza (Reference).
|
5.0%
1/20 • Number of events 1 • From start of study drug administration up to end of study visit (up to Day 6)
Analysis was performed using safety population. Out of 21 participants, 16 participants who were dosed with NicoDerm CQ Dungarvan (Test) and 20 participants dosed with NicoDerm CQ Alza (Reference).
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Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/16 • From start of study drug administration up to end of study visit (up to Day 6)
Analysis was performed using safety population. Out of 21 participants, 16 participants who were dosed with NicoDerm CQ Dungarvan (Test) and 20 participants dosed with NicoDerm CQ Alza (Reference).
|
5.0%
1/20 • Number of events 1 • From start of study drug administration up to end of study visit (up to Day 6)
Analysis was performed using safety population. Out of 21 participants, 16 participants who were dosed with NicoDerm CQ Dungarvan (Test) and 20 participants dosed with NicoDerm CQ Alza (Reference).
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Psychiatric disorders
Abnormal dreams
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6.2%
1/16 • Number of events 1 • From start of study drug administration up to end of study visit (up to Day 6)
Analysis was performed using safety population. Out of 21 participants, 16 participants who were dosed with NicoDerm CQ Dungarvan (Test) and 20 participants dosed with NicoDerm CQ Alza (Reference).
|
10.0%
2/20 • Number of events 2 • From start of study drug administration up to end of study visit (up to Day 6)
Analysis was performed using safety population. Out of 21 participants, 16 participants who were dosed with NicoDerm CQ Dungarvan (Test) and 20 participants dosed with NicoDerm CQ Alza (Reference).
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Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/16 • From start of study drug administration up to end of study visit (up to Day 6)
Analysis was performed using safety population. Out of 21 participants, 16 participants who were dosed with NicoDerm CQ Dungarvan (Test) and 20 participants dosed with NicoDerm CQ Alza (Reference).
|
10.0%
2/20 • Number of events 2 • From start of study drug administration up to end of study visit (up to Day 6)
Analysis was performed using safety population. Out of 21 participants, 16 participants who were dosed with NicoDerm CQ Dungarvan (Test) and 20 participants dosed with NicoDerm CQ Alza (Reference).
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Respiratory, thoracic and mediastinal disorders
Cough
|
6.2%
1/16 • Number of events 1 • From start of study drug administration up to end of study visit (up to Day 6)
Analysis was performed using safety population. Out of 21 participants, 16 participants who were dosed with NicoDerm CQ Dungarvan (Test) and 20 participants dosed with NicoDerm CQ Alza (Reference).
|
0.00%
0/20 • From start of study drug administration up to end of study visit (up to Day 6)
Analysis was performed using safety population. Out of 21 participants, 16 participants who were dosed with NicoDerm CQ Dungarvan (Test) and 20 participants dosed with NicoDerm CQ Alza (Reference).
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Respiratory, thoracic and mediastinal disorders
Productive cough
|
6.2%
1/16 • Number of events 1 • From start of study drug administration up to end of study visit (up to Day 6)
Analysis was performed using safety population. Out of 21 participants, 16 participants who were dosed with NicoDerm CQ Dungarvan (Test) and 20 participants dosed with NicoDerm CQ Alza (Reference).
|
0.00%
0/20 • From start of study drug administration up to end of study visit (up to Day 6)
Analysis was performed using safety population. Out of 21 participants, 16 participants who were dosed with NicoDerm CQ Dungarvan (Test) and 20 participants dosed with NicoDerm CQ Alza (Reference).
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Cardiac disorders
Palpitations
|
0.00%
0/16 • From start of study drug administration up to end of study visit (up to Day 6)
Analysis was performed using safety population. Out of 21 participants, 16 participants who were dosed with NicoDerm CQ Dungarvan (Test) and 20 participants dosed with NicoDerm CQ Alza (Reference).
|
5.0%
1/20 • Number of events 1 • From start of study drug administration up to end of study visit (up to Day 6)
Analysis was performed using safety population. Out of 21 participants, 16 participants who were dosed with NicoDerm CQ Dungarvan (Test) and 20 participants dosed with NicoDerm CQ Alza (Reference).
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Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/16 • From start of study drug administration up to end of study visit (up to Day 6)
Analysis was performed using safety population. Out of 21 participants, 16 participants who were dosed with NicoDerm CQ Dungarvan (Test) and 20 participants dosed with NicoDerm CQ Alza (Reference).
|
5.0%
1/20 • Number of events 1 • From start of study drug administration up to end of study visit (up to Day 6)
Analysis was performed using safety population. Out of 21 participants, 16 participants who were dosed with NicoDerm CQ Dungarvan (Test) and 20 participants dosed with NicoDerm CQ Alza (Reference).
|
|
Vascular disorders
Hot flush
|
6.2%
1/16 • Number of events 1 • From start of study drug administration up to end of study visit (up to Day 6)
Analysis was performed using safety population. Out of 21 participants, 16 participants who were dosed with NicoDerm CQ Dungarvan (Test) and 20 participants dosed with NicoDerm CQ Alza (Reference).
|
0.00%
0/20 • From start of study drug administration up to end of study visit (up to Day 6)
Analysis was performed using safety population. Out of 21 participants, 16 participants who were dosed with NicoDerm CQ Dungarvan (Test) and 20 participants dosed with NicoDerm CQ Alza (Reference).
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee HALEON agreements may vary with individual investigators but will not prohibit any investigator from publishing. HALEON 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