Trial Outcomes & Findings for Study to Investigate the Nicotine Pharmacokinetic Profiles and Pharmacodynamic Effects of P4M3 Variants (NCT NCT03379740)
NCT ID: NCT03379740
Last Updated: 2019-11-22
Results Overview
To measure background-corrected peak plasma nicotine concentration \[cCpeak\] from 60 minutes of ad libitum use.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
15 participants
Primary outcome timeframe
From Day -1 (baseline) to Day 4
Results posted on
2019-11-22
Participant Flow
Participant milestones
| Measure |
Product Exposure Sequence 1
Subjects will be randomized to follow a sequence of product exposure comprised of :
E-cigarette; P4M3-1.7%; P4M3-1.7%LA; P4M3-3%LA; and P4M3-4%LA
E-cigarette: Subject's own e-cigarette
P4M3-1.7%: P4M3 e-liquid concentration of 1.7% nicotine without lactic acid
P4M3-1.7%LA: P4M3 e-liquid concentration of 1.7% nicotine with lactic acid
P4M3-3%LA: P4M3 e-liquid concentration of 3% nicotine with lactic acid
P4M3-4%LA: P4M3 e-liquid concentration of 4% nicotine with lactic acid
|
Product Exposure Sequence 2
Subjects will be randomized to follow a sequence of product exposure comprised of :
E-cigarette; P4M3-1.7%LA; P4M3-1.7%; P4M3-3%LA; and P4M3-4%LA
E-cigarette: Subject's own e-cigarette
P4M3-1.7%: P4M3 e-liquid concentration of 1.7% nicotine without lactic acid
P4M3-1.7%LA: P4M3 e-liquid concentration of 1.7% nicotine with lactic acid
P4M3-3%LA: P4M3 e-liquid concentration of 3% nicotine with lactic acid
P4M3-4%LA: P4M3 e-liquid concentration of 4% nicotine with lactic acid
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
7
|
|
Overall Study
COMPLETED
|
8
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study to Investigate the Nicotine Pharmacokinetic Profiles and Pharmacodynamic Effects of P4M3 Variants
Baseline characteristics by cohort
| Measure |
Product Exposure Sequence 1
n=8 Participants
Subjects will be randomized to follow a sequence of product exposure comprised of :
E-cigarette; P4M3-1.7%; P4M3-1.7%LA; P4M3-3%LA; and P4M3-4%LA
E-cigarette: Subject's own e-cigarette
P4M3-1.7%: P4M3 e-liquid concentration of 1.7% nicotine without lactic acid
P4M3-1.7%LA: P4M3 e-liquid concentration of 1.7% nicotine with lactic acid
P4M3-3%LA: P4M3 e-liquid concentration of 3% nicotine with lactic acid
P4M3-4%LA: P4M3 e-liquid concentration of 4% nicotine with lactic acid
|
Product Exposure Sequence 2
n=7 Participants
Subjects will be randomized to follow a sequence of product exposure comprised of :
E-cigarette; P4M3-1.7%LA; P4M3-1.7%; P4M3-3%LA; and P4M3-4%LA
E-cigarette: Subject's own e-cigarette
P4M3-1.7%: P4M3 e-liquid concentration of 1.7% nicotine without lactic acid
P4M3-1.7%LA: P4M3 e-liquid concentration of 1.7% nicotine with lactic acid
P4M3-3%LA: P4M3 e-liquid concentration of 3% nicotine with lactic acid
P4M3-4%LA: P4M3 e-liquid concentration of 4% nicotine with lactic acid
|
Total
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
38.3 years
n=5 Participants
|
42.0 years
n=7 Participants
|
40.0 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Weight (kg)
|
83.95 kg
n=5 Participants
|
70.41 kg
n=7 Participants
|
77.63 kg
n=5 Participants
|
|
Height (cm)
|
178.2 cm
n=5 Participants
|
165.0 cm
n=7 Participants
|
172.1 cm
n=5 Participants
|
|
BMI (kg/m^2)
|
26.361 kg/m^2
n=5 Participants
|
26.174 kg/m^2
n=7 Participants
|
26.274 kg/m^2
n=5 Participants
|
PRIMARY outcome
Timeframe: From Day -1 (baseline) to Day 4To measure total and background-corrected plasma nicotine concentration versus time profiles from 60 minutes of ad libitum use.
Outcome measures
| Measure |
Subject's Own E-cigarette
n=15 Participants
Subject's own e-cigarette with e-liquid
|
P4M3-1.7%
n=15 Participants
P4M3 with e-liquid concentrations of 1.7% nicotine without lactic acid
|
P4M3-1.7%LA
n=15 Participants
P4M3 with e-liquid concentrations of 1.7% nicotine with lactic acid
|
P4M3-3%LA
n=15 Participants
P4M3 with e-liquid concentrations of 3% nicotine with lactic acid
|
P4M3-4%LA
n=15 Participants
P4M3 with e-liquid concentrations of 4% nicotine with lactic acid
|
|---|---|---|---|---|---|
|
Plasma Nicotine Concentration Versus Time Profile
10 mins
|
4.546 ng/mL
Geometric Coefficient of Variation 99.52
|
3.165 ng/mL
Geometric Coefficient of Variation 77.27
|
4.167 ng/mL
Geometric Coefficient of Variation 119.38
|
7.518 ng/mL
Geometric Coefficient of Variation 93.39
|
6.782 ng/mL
Geometric Coefficient of Variation 95.57
|
|
Plasma Nicotine Concentration Versus Time Profile
20 mins
|
7.235 ng/mL
Geometric Coefficient of Variation 103.89
|
5.237 ng/mL
Geometric Coefficient of Variation 65.20
|
6.990 ng/mL
Geometric Coefficient of Variation 121.67
|
11.92 ng/mL
Geometric Coefficient of Variation 65.52
|
9.942 ng/mL
Geometric Coefficient of Variation 65.34
|
|
Plasma Nicotine Concentration Versus Time Profile
30 mins
|
8.852 ng/mL
Geometric Coefficient of Variation 113.80
|
7.808 ng/mL
Geometric Coefficient of Variation 62.57
|
8.165 ng/mL
Geometric Coefficient of Variation 111.02
|
17.85 ng/mL
Geometric Coefficient of Variation 66.05
|
14.65 ng/mL
Geometric Coefficient of Variation 60.02
|
|
Plasma Nicotine Concentration Versus Time Profile
40 mins
|
10.25 ng/mL
Geometric Coefficient of Variation 111.09
|
9.338 ng/mL
Geometric Coefficient of Variation 61.00
|
9.852 ng/mL
Geometric Coefficient of Variation 99.60
|
20.72 ng/mL
Geometric Coefficient of Variation 63.01
|
19.17 ng/mL
Geometric Coefficient of Variation 56.21
|
|
Plasma Nicotine Concentration Versus Time Profile
60 mins
|
14.46 ng/mL
Geometric Coefficient of Variation 80.78
|
13.24 ng/mL
Geometric Coefficient of Variation 55.46
|
12.64 ng/mL
Geometric Coefficient of Variation 96.63
|
25.53 ng/mL
Geometric Coefficient of Variation 62.65
|
25.77 ng/mL
Geometric Coefficient of Variation 55.60
|
|
Plasma Nicotine Concentration Versus Time Profile
120 mins
|
8.809 ng/mL
Geometric Coefficient of Variation 90.18
|
9.356 ng/mL
Geometric Coefficient of Variation 69.35
|
7.157 ng/mL
Geometric Coefficient of Variation 102.04
|
15.52 ng/mL
Geometric Coefficient of Variation 52.34
|
12.76 ng/mL
Geometric Coefficient of Variation 50.27
|
|
Plasma Nicotine Concentration Versus Time Profile
240 mins
|
4.297 ng/mL
Geometric Coefficient of Variation 91.97
|
4.524 ng/mL
Geometric Coefficient of Variation 76.68
|
3.311 ng/mL
Geometric Coefficient of Variation 91.70
|
7.490 ng/mL
Geometric Coefficient of Variation 53.81
|
5.681 ng/mL
Geometric Coefficient of Variation 45.33
|
PRIMARY outcome
Timeframe: From Day -1 (baseline) to Day 4To measure background-corrected peak plasma nicotine concentration \[cCpeak\] from 60 minutes of ad libitum use.
Outcome measures
| Measure |
Subject's Own E-cigarette
n=15 Participants
Subject's own e-cigarette with e-liquid
|
P4M3-1.7%
n=15 Participants
P4M3 with e-liquid concentrations of 1.7% nicotine without lactic acid
|
P4M3-1.7%LA
n=15 Participants
P4M3 with e-liquid concentrations of 1.7% nicotine with lactic acid
|
P4M3-3%LA
n=15 Participants
P4M3 with e-liquid concentrations of 3% nicotine with lactic acid
|
P4M3-4%LA
n=15 Participants
P4M3 with e-liquid concentrations of 4% nicotine with lactic acid
|
|---|---|---|---|---|---|
|
Peak Plasma Nicotine Concentration [cCpeak]
|
14.87 ng/mL
Geometric Coefficient of Variation 83.01
|
13.32 ng/mL
Geometric Coefficient of Variation 55.65
|
13.05 ng/mL
Geometric Coefficient of Variation 98.16
|
26.47 ng/mL
Geometric Coefficient of Variation 63.68
|
26.57 ng/mL
Geometric Coefficient of Variation 57.34
|
PRIMARY outcome
Timeframe: From Day -1 (baseline) to Day 4To measure the time to peak plasma nicotine concentration \[tpeak\] from 60 minutes of ad libitum use.
Outcome measures
| Measure |
Subject's Own E-cigarette
n=15 Participants
Subject's own e-cigarette with e-liquid
|
P4M3-1.7%
n=15 Participants
P4M3 with e-liquid concentrations of 1.7% nicotine without lactic acid
|
P4M3-1.7%LA
n=15 Participants
P4M3 with e-liquid concentrations of 1.7% nicotine with lactic acid
|
P4M3-3%LA
n=15 Participants
P4M3 with e-liquid concentrations of 3% nicotine with lactic acid
|
P4M3-4%LA
n=15 Participants
P4M3 with e-liquid concentrations of 4% nicotine with lactic acid
|
|---|---|---|---|---|---|
|
Time to Peak Plasma Nicotine Concentration [Tpeak]
|
60.000 minutes
Interval 30.0 to 65.0
|
60.000 minutes
Interval 60.0 to 122.0
|
60.000 minutes
Interval 40.0 to 60.0
|
60.000 minutes
Interval 30.0 to 60.0
|
60.000 minutes
Interval 40.0 to 65.0
|
PRIMARY outcome
Timeframe: From Day -1 (baseline) to Day 4To measure background-corrected trough plasma nicotine concentration \[cCtrough\] from 60 minutes of ad libitum use.
Outcome measures
| Measure |
Subject's Own E-cigarette
n=15 Participants
Subject's own e-cigarette with e-liquid
|
P4M3-1.7%
n=15 Participants
P4M3 with e-liquid concentrations of 1.7% nicotine without lactic acid
|
P4M3-1.7%LA
n=15 Participants
P4M3 with e-liquid concentrations of 1.7% nicotine with lactic acid
|
P4M3-3%LA
n=15 Participants
P4M3 with e-liquid concentrations of 3% nicotine with lactic acid
|
P4M3-4%LA
n=15 Participants
P4M3 with e-liquid concentrations of 4% nicotine with lactic acid
|
|---|---|---|---|---|---|
|
Background-corrected Trough Plasma Nicotine Concentration [cCtrough]
|
3.492 ng/mL
Geometric Coefficient of Variation 98.26
|
2.819 ng/mL
Geometric Coefficient of Variation 74.17
|
2.905 ng/mL
Geometric Coefficient of Variation 101.32
|
6.032 ng/mL
Geometric Coefficient of Variation 73.40
|
4.845 ng/mL
Geometric Coefficient of Variation 59.40
|
PRIMARY outcome
Timeframe: From Day -1 (baseline) to Day 4To measure background-corrected average of plasma nicotine concentration between 0 to 1 hour \[cCaverage\] from 60 minutes of ad libitum use.
Outcome measures
| Measure |
Subject's Own E-cigarette
n=15 Participants
Subject's own e-cigarette with e-liquid
|
P4M3-1.7%
n=15 Participants
P4M3 with e-liquid concentrations of 1.7% nicotine without lactic acid
|
P4M3-1.7%LA
n=15 Participants
P4M3 with e-liquid concentrations of 1.7% nicotine with lactic acid
|
P4M3-3%LA
n=15 Participants
P4M3 with e-liquid concentrations of 3% nicotine with lactic acid
|
P4M3-4%LA
n=15 Participants
P4M3 with e-liquid concentrations of 4% nicotine with lactic acid
|
|---|---|---|---|---|---|
|
Background-corrected Average of Plasma Nicotine Concentration [cCaverage]
|
8.548 ng/mL
Geometric Coefficient of Variation 95.38
|
7.302 ng/mL
Geometric Coefficient of Variation 55.95
|
7.870 ng/mL
Geometric Coefficient of Variation 101.89
|
16.03 ng/mL
Geometric Coefficient of Variation 62.01
|
14.48 ng/mL
Geometric Coefficient of Variation 55.31
|
SECONDARY outcome
Timeframe: From Day -1 (baseline) to Day 4To measure the total and background-corrected plasma nicotine concentration versus time profiles of the P4M3 variants and subjects' own e-cigarette from the fixed puffing regimen.
Outcome measures
| Measure |
Subject's Own E-cigarette
n=15 Participants
Subject's own e-cigarette with e-liquid
|
P4M3-1.7%
n=15 Participants
P4M3 with e-liquid concentrations of 1.7% nicotine without lactic acid
|
P4M3-1.7%LA
n=15 Participants
P4M3 with e-liquid concentrations of 1.7% nicotine with lactic acid
|
P4M3-3%LA
n=15 Participants
P4M3 with e-liquid concentrations of 3% nicotine with lactic acid
|
P4M3-4%LA
n=15 Participants
P4M3 with e-liquid concentrations of 4% nicotine with lactic acid
|
|---|---|---|---|---|---|
|
Total and Background-corrected Plasma Nicotine Concentration Versus Time Profiles
2 mins
|
1.228 ng/mL
Geometric Coefficient of Variation 138.63
|
0.7868 ng/mL
Geometric Coefficient of Variation 268.65
|
1.620 ng/mL
Geometric Coefficient of Variation 117.19
|
2.025 ng/mL
Geometric Coefficient of Variation 165.36
|
3.634 ng/mL
Geometric Coefficient of Variation 143.44
|
|
Total and Background-corrected Plasma Nicotine Concentration Versus Time Profiles
4 mins
|
3.158 ng/mL
Geometric Coefficient of Variation 107.95
|
1.915 ng/mL
Geometric Coefficient of Variation 120.88
|
4.048 ng/mL
Geometric Coefficient of Variation 126.28
|
4.817 ng/mL
Geometric Coefficient of Variation 113.35
|
7.356 ng/mL
Geometric Coefficient of Variation 65.15
|
|
Total and Background-corrected Plasma Nicotine Concentration Versus Time Profiles
7 mins
|
4.960 ng/mL
Geometric Coefficient of Variation 81.41
|
3.992 ng/mL
Geometric Coefficient of Variation 77.63
|
5.869 ng/mL
Geometric Coefficient of Variation 83.79
|
8.162 ng/mL
Geometric Coefficient of Variation 67.20
|
9.905 ng/mL
Geometric Coefficient of Variation 69.36
|
|
Total and Background-corrected Plasma Nicotine Concentration Versus Time Profiles
10 mins
|
4.443 ng/mL
Geometric Coefficient of Variation 80.92
|
4.386 ng/mL
Geometric Coefficient of Variation 66.40
|
5.232 ng/mL
Geometric Coefficient of Variation 72.58
|
7.793 ng/mL
Geometric Coefficient of Variation 57.17
|
9.480 ng/mL
Geometric Coefficient of Variation 68.97
|
|
Total and Background-corrected Plasma Nicotine Concentration Versus Time Profiles
15 mins
|
3.810 ng/mL
Geometric Coefficient of Variation 71.38
|
3.788 ng/mL
Geometric Coefficient of Variation 60.59
|
4.250 ng/mL
Geometric Coefficient of Variation 74.72
|
7.251 ng/mL
Geometric Coefficient of Variation 57.53
|
8.152 ng/mL
Geometric Coefficient of Variation 57.85
|
|
Total and Background-corrected Plasma Nicotine Concentration Versus Time Profiles
30 mins
|
3.209 ng/mL
Geometric Coefficient of Variation 83.26
|
2.704 ng/mL
Geometric Coefficient of Variation 98.56
|
3.202 ng/mL
Geometric Coefficient of Variation 73.14
|
5.232 ng/mL
Geometric Coefficient of Variation 57.79
|
6.203 ng/mL
Geometric Coefficient of Variation 66.86
|
|
Total and Background-corrected Plasma Nicotine Concentration Versus Time Profiles
60 mins
|
2.365 ng/mL
Geometric Coefficient of Variation 93.30
|
2.300 ng/mL
Geometric Coefficient of Variation 52.26
|
2.352 ng/mL
Geometric Coefficient of Variation 71.13
|
3.646 ng/mL
Geometric Coefficient of Variation 62.22
|
4.238 ng/mL
Geometric Coefficient of Variation 74.41
|
|
Total and Background-corrected Plasma Nicotine Concentration Versus Time Profiles
120 mins
|
1.579 ng/mL
Geometric Coefficient of Variation 96.29
|
1.292 ng/mL
Geometric Coefficient of Variation 52.31
|
1.479 ng/mL
Geometric Coefficient of Variation 68.44
|
2.074 ng/mL
Geometric Coefficient of Variation 65.23
|
2.398 ng/mL
Geometric Coefficient of Variation 79.90
|
|
Total and Background-corrected Plasma Nicotine Concentration Versus Time Profiles
240 mins
|
0.8435 ng/mL
Geometric Coefficient of Variation 81.99
|
0.6550 ng/mL
Geometric Coefficient of Variation 50.33
|
0.6794 ng/mL
Geometric Coefficient of Variation 84.09
|
1.038 ng/mL
Geometric Coefficient of Variation 54.59
|
1.183 ng/mL
Geometric Coefficient of Variation 74.31
|
SECONDARY outcome
Timeframe: From Day -1 (baseline) to Day 4To measure the background-corrected maximum plasma concentration \[cCmax\] of the P4M3 variants and subjects' own e-cigarette from the fixed puffing regimen.
Outcome measures
| Measure |
Subject's Own E-cigarette
n=15 Participants
Subject's own e-cigarette with e-liquid
|
P4M3-1.7%
n=14 Participants
P4M3 with e-liquid concentrations of 1.7% nicotine without lactic acid
|
P4M3-1.7%LA
n=14 Participants
P4M3 with e-liquid concentrations of 1.7% nicotine with lactic acid
|
P4M3-3%LA
n=15 Participants
P4M3 with e-liquid concentrations of 3% nicotine with lactic acid
|
P4M3-4%LA
n=15 Participants
P4M3 with e-liquid concentrations of 4% nicotine with lactic acid
|
|---|---|---|---|---|---|
|
Background-corrected Maximum Plasma Concentration [cCmax]
|
5.402 ng/mL
Geometric Coefficient of Variation 78.06
|
5.074 ng/mL
Geometric Coefficient of Variation 77.64
|
6.735 ng/mL
Geometric Coefficient of Variation 83.39
|
9.437 ng/mL
Geometric Coefficient of Variation 63.11
|
11.990 ng/mL
Geometric Coefficient of Variation 78.62
|
SECONDARY outcome
Timeframe: From Day -1 (baseline) to Day 4To measure the time to the maximum concentration \[tmax\] of the P4M3 variants and subjects' own e-cigarette from the fixed puffing regimen.
Outcome measures
| Measure |
Subject's Own E-cigarette
n=15 Participants
Subject's own e-cigarette with e-liquid
|
P4M3-1.7%
n=14 Participants
P4M3 with e-liquid concentrations of 1.7% nicotine without lactic acid
|
P4M3-1.7%LA
n=14 Participants
P4M3 with e-liquid concentrations of 1.7% nicotine with lactic acid
|
P4M3-3%LA
n=15 Participants
P4M3 with e-liquid concentrations of 3% nicotine with lactic acid
|
P4M3-4%LA
n=15 Participants
P4M3 with e-liquid concentrations of 4% nicotine with lactic acid
|
|---|---|---|---|---|---|
|
Time to the Maximum Concentration [Tmax]
|
10.002 minutes
Interval 4.0 to 120.0
|
10.002 minutes
Interval 4.0 to 60.0
|
7.002 minutes
Interval 4.0 to 30.0
|
10.002 minutes
Interval 4.0 to 15.0
|
7.002 minutes
Interval 2.0 to 15.0
|
SECONDARY outcome
Timeframe: From Day -1 (baseline) to Day 4Population: Values below the Lower Limit of Quantification were set to missing.
To measure the background-corrected area under the concentration-time curve, which is above the corrected baseline from the start of product use to 4 hours \[cAUC(0-4h)\], of the P4M3 variants and subjects' own e-cigarette from the fixed puffing regimen.
Outcome measures
| Measure |
Subject's Own E-cigarette
n=15 Participants
Subject's own e-cigarette with e-liquid
|
P4M3-1.7%
n=15 Participants
P4M3 with e-liquid concentrations of 1.7% nicotine without lactic acid
|
P4M3-1.7%LA
n=15 Participants
P4M3 with e-liquid concentrations of 1.7% nicotine with lactic acid
|
P4M3-3%LA
n=15 Participants
P4M3 with e-liquid concentrations of 3% nicotine with lactic acid
|
P4M3-4%LA
n=15 Participants
P4M3 with e-liquid concentrations of 4% nicotine with lactic acid
|
|---|---|---|---|---|---|
|
Background-corrected Area Under the Concentration-time Curve [cAUC(0-4h)]
Fixed Regimen
|
7.796 ng*h/mL
Geometric Coefficient of Variation 81.19
|
6.969 ng*h/mL
Geometric Coefficient of Variation 50.19
|
7.679 ng*h/mL
Geometric Coefficient of Variation 66.36
|
11.55 ng*h/mL
Geometric Coefficient of Variation 56.00
|
13.570 ng*h/mL
Geometric Coefficient of Variation 67.10
|
|
Background-corrected Area Under the Concentration-time Curve [cAUC(0-4h)]
Ad libitum
|
33.77 ng*h/mL
Geometric Coefficient of Variation 86.94
|
33.03 ng*h/mL
Geometric Coefficient of Variation 61.44
|
28.64 ng*h/mL
Geometric Coefficient of Variation 96.87
|
60.21 ng*h/mL
Geometric Coefficient of Variation 55.29
|
52.79 ng*h/mL
Geometric Coefficient of Variation 50.19
|
SECONDARY outcome
Timeframe: From Day -1 (baseline) to Day 4Measured with an adapted version of the modified Cigarette Evaluation Questionnaire (adapted mCEQ) within 60 minutes after the ad libitum use session. Assessed on a 7-point scale, ranging from 1 (not at all) to 7 (extremely).
Outcome measures
| Measure |
Subject's Own E-cigarette
n=15 Participants
Subject's own e-cigarette with e-liquid
|
P4M3-1.7%
n=15 Participants
P4M3 with e-liquid concentrations of 1.7% nicotine without lactic acid
|
P4M3-1.7%LA
n=15 Participants
P4M3 with e-liquid concentrations of 1.7% nicotine with lactic acid
|
P4M3-3%LA
n=15 Participants
P4M3 with e-liquid concentrations of 3% nicotine with lactic acid
|
P4M3-4%LA
n=15 Participants
P4M3 with e-liquid concentrations of 4% nicotine with lactic acid
|
|---|---|---|---|---|---|
|
Subjective Effects of P4M3 Use
Psychological Reward
|
3.88 score on a scale
Standard Deviation 1.242
|
3.49 score on a scale
Standard Deviation 1.396
|
3.13 score on a scale
Standard Deviation 1.529
|
3.01 score on a scale
Standard Deviation 1.060
|
2.88 score on a scale
Standard Deviation 1.207
|
|
Subjective Effects of P4M3 Use
Enjoyment of Respiratory Tract Sensations
|
4.3 score on a scale
Standard Deviation 1.23
|
3.2 score on a scale
Standard Deviation 1.02
|
3.1 score on a scale
Standard Deviation 1.23
|
3.0 score on a scale
Standard Deviation 0.93
|
2.9 score on a scale
Standard Deviation 1.28
|
|
Subjective Effects of P4M3 Use
Craving Reduction
|
4.3 score on a scale
Standard Deviation 1.67
|
3.9 score on a scale
Standard Deviation 1.25
|
3.7 score on a scale
Standard Deviation 1.80
|
3.6 score on a scale
Standard Deviation 1.51
|
3.5 score on a scale
Standard Deviation 1.85
|
|
Subjective Effects of P4M3 Use
Product Satisfaction
|
4.76 score on a scale
Standard Deviation 1.058
|
3.62 score on a scale
Standard Deviation 1.425
|
3.49 score on a scale
Standard Deviation 1.667
|
3.24 score on a scale
Standard Deviation 1.165
|
3.04 score on a scale
Standard Deviation 1.469
|
|
Subjective Effects of P4M3 Use
Aversion
|
1.77 score on a scale
Standard Deviation 0.864
|
1.57 score on a scale
Standard Deviation 0.843
|
2.00 score on a scale
Standard Deviation 1.036
|
2.37 score on a scale
Standard Deviation 1.518
|
2.53 score on a scale
Standard Deviation 1.788
|
SECONDARY outcome
Timeframe: From Day -1 (baseline) to Day 4Measured on a Visual Analogue Scale (VAS) of 0 (no craving) to 100 (strong craving), before and after the fixed puffing regimen and ad libitum use period. (The VAS craving was measured from 0 to 100 on a 100 mm scale.) The data below present the Area under the VAS craving score-time curve from the start of product use to 4 hours. The area under the curve for VAS craving is an integrated measurement of the VAS craving taking into account several timepoints. AUC was calculated using a trapezoidal rule between timepoints without normalization.
Outcome measures
| Measure |
Subject's Own E-cigarette
n=15 Participants
Subject's own e-cigarette with e-liquid
|
P4M3-1.7%
n=15 Participants
P4M3 with e-liquid concentrations of 1.7% nicotine without lactic acid
|
P4M3-1.7%LA
n=15 Participants
P4M3 with e-liquid concentrations of 1.7% nicotine with lactic acid
|
P4M3-3%LA
n=15 Participants
P4M3 with e-liquid concentrations of 3% nicotine with lactic acid
|
P4M3-4%LA
n=15 Participants
P4M3 with e-liquid concentrations of 4% nicotine with lactic acid
|
|---|---|---|---|---|---|
|
Area Under the Curve of Craving for an Electronic Cigarette
Ad Libitum
|
143.2 score*hr
Standard Deviation 87.05
|
117.9 score*hr
Standard Deviation 84.65
|
119.5 score*hr
Standard Deviation 100.03
|
108.0 score*hr
Standard Deviation 89.93
|
96.9 score*hr
Standard Deviation 90.26
|
|
Area Under the Curve of Craving for an Electronic Cigarette
Fixed Puffing
|
154.8 score*hr
Standard Deviation 120.90
|
134.4 score*hr
Standard Deviation 117.02
|
135.5 score*hr
Standard Deviation 120.61
|
141.8 score*hr
Standard Deviation 105.87
|
124.9 score*hr
Standard Deviation 106.80
|
SECONDARY outcome
Timeframe: From Day 1 to Day 4Measured with a Sensory Questionnaire (SQ) within 60 minutes after each fixed puffing regimen use period. Response to each question is assessed on a 7-point scale, ranging from 1 (not at all) to 7 (extremely).
Outcome measures
| Measure |
Subject's Own E-cigarette
n=15 Participants
Subject's own e-cigarette with e-liquid
|
P4M3-1.7%
n=15 Participants
P4M3 with e-liquid concentrations of 1.7% nicotine without lactic acid
|
P4M3-1.7%LA
n=15 Participants
P4M3 with e-liquid concentrations of 1.7% nicotine with lactic acid
|
P4M3-3%LA
n=15 Participants
P4M3 with e-liquid concentrations of 3% nicotine with lactic acid
|
P4M3-4%LA
n=15 Participants
P4M3 with e-liquid concentrations of 4% nicotine with lactic acid
|
|---|---|---|---|---|---|
|
Sensory Parameters (Fixed Puffing Regimen)
How much did you like the puffs you took?
|
4.9 score on a scale
Standard Deviation 1.41
|
3.7 score on a scale
Standard Deviation 1.34
|
3.7 score on a scale
Standard Deviation 1.86
|
3.5 score on a scale
Standard Deviation 1.73
|
3.5 score on a scale
Standard Deviation 1.25
|
|
Sensory Parameters (Fixed Puffing Regimen)
How similar to your own brand were the puffs?
|
3.6 score on a scale
Standard Deviation 1.81
|
2.3 score on a scale
Standard Deviation 1.18
|
2.3 score on a scale
Standard Deviation 1.64
|
2.1 score on a scale
Standard Deviation 1.07
|
2.3 score on a scale
Standard Deviation 1.12
|
|
Sensory Parameters (Fixed Puffing Regimen)
Strength of puffs on tongue?
|
2.5 score on a scale
Standard Deviation 1.13
|
2.8 score on a scale
Standard Deviation 1.09
|
2.5 score on a scale
Standard Deviation 1.10
|
2.8 score on a scale
Standard Deviation 1.21
|
3.0 score on a scale
Standard Deviation 1.26
|
|
Sensory Parameters (Fixed Puffing Regimen)
Strength of puffs in back of mouth & throat?
|
3.7 score on a scale
Standard Deviation 1.30
|
4.1 score on a scale
Standard Deviation 1.19
|
2.9 score on a scale
Standard Deviation 1.10
|
3.9 score on a scale
Standard Deviation 1.34
|
3.9 score on a scale
Standard Deviation 1.51
|
|
Sensory Parameters (Fixed Puffing Regimen)
Strength of puffs in windpipe?
|
3.3 score on a scale
Standard Deviation 1.44
|
4.1 score on a scale
Standard Deviation 1.10
|
3.1 score on a scale
Standard Deviation 1.08
|
4.1 score on a scale
Standard Deviation 1.49
|
3.8 score on a scale
Standard Deviation 1.57
|
|
Sensory Parameters (Fixed Puffing Regimen)
Strength puffs in chest?
|
2.9 score on a scale
Standard Deviation 1.13
|
3.5 score on a scale
Standard Deviation 1.41
|
2.2 score on a scale
Standard Deviation 1.13
|
3.5 score on a scale
Standard Deviation 1.83
|
3.2 score on a scale
Standard Deviation 1.66
|
|
Sensory Parameters (Fixed Puffing Regimen)
How harsh were the puffs you took?
|
3.6 score on a scale
Standard Deviation 1.41
|
4.4 score on a scale
Standard Deviation 1.30
|
3.2 score on a scale
Standard Deviation 1.53
|
4.1 score on a scale
Standard Deviation 1.19
|
3.7 score on a scale
Standard Deviation 1.54
|
|
Sensory Parameters (Fixed Puffing Regimen)
Strength of puffs in nose?
|
1.9 score on a scale
Standard Deviation 0.92
|
2.2 score on a scale
Standard Deviation 1.02
|
1.8 score on a scale
Standard Deviation 0.81
|
2.2 score on a scale
Standard Deviation 0.87
|
2.3 score on a scale
Standard Deviation 1.23
|
SECONDARY outcome
Timeframe: From Day 1 to Day 4Measured with a Sensory Questionnaire (SQ) within 60 minutes after each ad libitum use period. Response to each question is assessed on a 7-point scale, ranging from 1 (not at all) to 7 (extremely).
Outcome measures
| Measure |
Subject's Own E-cigarette
n=15 Participants
Subject's own e-cigarette with e-liquid
|
P4M3-1.7%
n=15 Participants
P4M3 with e-liquid concentrations of 1.7% nicotine without lactic acid
|
P4M3-1.7%LA
n=15 Participants
P4M3 with e-liquid concentrations of 1.7% nicotine with lactic acid
|
P4M3-3%LA
n=15 Participants
P4M3 with e-liquid concentrations of 3% nicotine with lactic acid
|
P4M3-4%LA
n=15 Participants
P4M3 with e-liquid concentrations of 4% nicotine with lactic acid
|
|---|---|---|---|---|---|
|
Sensory Parameters (ad Libitum Use)
How much did you like the puffs you took?
|
4.7 score on a scale
Standard Deviation 1.23
|
3.9 score on a scale
Standard Deviation 1.69
|
3.4 score on a scale
Standard Deviation 1.64
|
3.6 score on a scale
Standard Deviation 1.30
|
3.1 score on a scale
Standard Deviation 1.21
|
|
Sensory Parameters (ad Libitum Use)
How harsh were the puffs you took?
|
3.1 score on a scale
Standard Deviation 1.28
|
3.9 score on a scale
Standard Deviation 1.44
|
3.3 score on a scale
Standard Deviation 1.45
|
3.3 score on a scale
Standard Deviation 1.80
|
3.9 score on a scale
Standard Deviation 1.57
|
|
Sensory Parameters (ad Libitum Use)
How similar to your own brand were the puffs?
|
3.8 score on a scale
Standard Deviation 2.05
|
2.2 score on a scale
Standard Deviation 1.09
|
2.1 score on a scale
Standard Deviation 1.34
|
2.1 score on a scale
Standard Deviation 1.04
|
2.1 score on a scale
Standard Deviation 1.00
|
|
Sensory Parameters (ad Libitum Use)
Strength of puffs on tongue?
|
3.0 score on a scale
Standard Deviation 1.20
|
2.7 score on a scale
Standard Deviation 1.05
|
2.5 score on a scale
Standard Deviation 1.07
|
2.8 score on a scale
Standard Deviation 1.15
|
2.5 score on a scale
Standard Deviation 1.17
|
|
Sensory Parameters (ad Libitum Use)
Strength of puffs in nose?
|
2.1 score on a scale
Standard Deviation 1.04
|
2.0 score on a scale
Standard Deviation 0.93
|
2.0 score on a scale
Standard Deviation 1.07
|
2.1 score on a scale
Standard Deviation 0.89
|
1.8 score on a scale
Standard Deviation 0.70
|
|
Sensory Parameters (ad Libitum Use)
Strength of puffs in windpipe?
|
3.5 score on a scale
Standard Deviation 1.00
|
3.9 score on a scale
Standard Deviation 1.63
|
2.9 score on a scale
Standard Deviation 0.89
|
3.5 score on a scale
Standard Deviation 1.31
|
3.7 score on a scale
Standard Deviation 1.59
|
|
Sensory Parameters (ad Libitum Use)
Strength puffs in chest?
|
3.1 score on a scale
Standard Deviation 1.04
|
3.3 score on a scale
Standard Deviation 1.55
|
2.9 score on a scale
Standard Deviation 1.07
|
3.3 score on a scale
Standard Deviation 1.45
|
3.2 score on a scale
Standard Deviation 1.58
|
|
Sensory Parameters (ad Libitum Use)
Strength of puffs in back of mouth & throat?
|
3.5 score on a scale
Standard Deviation 0.92
|
3.5 score on a scale
Standard Deviation 1.46
|
2.7 score on a scale
Standard Deviation 1.17
|
3.4 score on a scale
Standard Deviation 1.25
|
3.7 score on a scale
Standard Deviation 1.59
|
SECONDARY outcome
Timeframe: From Day -1 (baseline) to Day 4Population: HPT raw data were reviewed for recording errors by personnel independent from the study and accepted or rejected prior to analysis. HPT data with the 'Rejected' status were excluded from the analysis. Consequently, the number of subjects analyzed differ from the overall number of subjects analyzed.
Total Puff Volume measured for the P4M3 variants and the subjects' own e-cigarette from the fixed puffing regimen and the 60 minutes ad libitum use.
Outcome measures
| Measure |
Subject's Own E-cigarette
n=15 Participants
Subject's own e-cigarette with e-liquid
|
P4M3-1.7%
n=15 Participants
P4M3 with e-liquid concentrations of 1.7% nicotine without lactic acid
|
P4M3-1.7%LA
n=15 Participants
P4M3 with e-liquid concentrations of 1.7% nicotine with lactic acid
|
P4M3-3%LA
n=15 Participants
P4M3 with e-liquid concentrations of 3% nicotine with lactic acid
|
P4M3-4%LA
n=15 Participants
P4M3 with e-liquid concentrations of 4% nicotine with lactic acid
|
|---|---|---|---|---|---|
|
Human Puffing Topography (HPT) of the P4M3 Variants and the Subjects' Own E-cigarette
Ad Libitum
|
2054.8081 mL (Total Puff Volume)
Interval 1699.3244 to 2881.098
|
2752.3456 mL (Total Puff Volume)
Interval 2232.0269 to 3976.0701
|
2945.8303 mL (Total Puff Volume)
Interval 2516.5662 to 4579.0958
|
2601.0945 mL (Total Puff Volume)
Interval 2241.0882 to 3226.3642
|
1934.8479 mL (Total Puff Volume)
Interval 1442.3779 to 2951.8173
|
|
Human Puffing Topography (HPT) of the P4M3 Variants and the Subjects' Own E-cigarette
Fixed Puffing
|
1103.2913 mL (Total Puff Volume)
Interval 896.5624 to 1682.3241
|
1133.2255 mL (Total Puff Volume)
Interval 878.6965 to 1844.3455
|
1235.2367 mL (Total Puff Volume)
Interval 874.7012 to 2069.0103
|
1139.8381 mL (Total Puff Volume)
Interval 857.5359 to 1877.5095
|
935.8970 mL (Total Puff Volume)
Interval 739.5238 to 1408.082
|
Adverse Events
P4M3-1.7% Product Test
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Subject's Own E-cigarette
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
P4M3-1.7%
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
P4M3-1.7%LA
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
P4M3-3%LA
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
P4M3-4%LA
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
P4M3-1.7% Product Test
n=15 participants at risk
On Admission Day (day -2) all subjects were invited to test the P4M3 product for 10 minutes.
|
Subject's Own E-cigarette
n=15 participants at risk
Subject's own e-cigarette with e-liquid
|
P4M3-1.7%
n=15 participants at risk
P4M3 with e-liquid concentrations of 1.7% nicotine without lactic acid
|
P4M3-1.7%LA
n=15 participants at risk
P4M3 with e-liquid concentrations of 1.7% nicotine with 1.1% lactic acid
|
P4M3-3%LA
n=15 participants at risk
P4M3 with e-liquid concentrations of 3% nicotine with 1.1% lactic acid
|
P4M3-4%LA
n=15 participants at risk
P4M3 with e-liquid concentrations of 4% nicotine with 2% lactic acid
|
|---|---|---|---|---|---|---|
|
Cardiac disorders
Tachycardia
|
0.00%
0/15 • Adverse events were collected over the entire study duration of up to 36 days, with individual subject participation of between 15 to 36 days from the signature of the Informed Consent Form (ICF) until the end of the safety follow-up period.
The safety was assessed in the safety population, consisting of all randomized subjects who gave informed consent and had exposure to at least one of the investigational products, including product test, as part of the study.
|
0.00%
0/15 • Adverse events were collected over the entire study duration of up to 36 days, with individual subject participation of between 15 to 36 days from the signature of the Informed Consent Form (ICF) until the end of the safety follow-up period.
The safety was assessed in the safety population, consisting of all randomized subjects who gave informed consent and had exposure to at least one of the investigational products, including product test, as part of the study.
|
0.00%
0/15 • Adverse events were collected over the entire study duration of up to 36 days, with individual subject participation of between 15 to 36 days from the signature of the Informed Consent Form (ICF) until the end of the safety follow-up period.
The safety was assessed in the safety population, consisting of all randomized subjects who gave informed consent and had exposure to at least one of the investigational products, including product test, as part of the study.
|
0.00%
0/15 • Adverse events were collected over the entire study duration of up to 36 days, with individual subject participation of between 15 to 36 days from the signature of the Informed Consent Form (ICF) until the end of the safety follow-up period.
The safety was assessed in the safety population, consisting of all randomized subjects who gave informed consent and had exposure to at least one of the investigational products, including product test, as part of the study.
|
6.7%
1/15 • Number of events 1 • Adverse events were collected over the entire study duration of up to 36 days, with individual subject participation of between 15 to 36 days from the signature of the Informed Consent Form (ICF) until the end of the safety follow-up period.
The safety was assessed in the safety population, consisting of all randomized subjects who gave informed consent and had exposure to at least one of the investigational products, including product test, as part of the study.
|
0.00%
0/15 • Adverse events were collected over the entire study duration of up to 36 days, with individual subject participation of between 15 to 36 days from the signature of the Informed Consent Form (ICF) until the end of the safety follow-up period.
The safety was assessed in the safety population, consisting of all randomized subjects who gave informed consent and had exposure to at least one of the investigational products, including product test, as part of the study.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/15 • Adverse events were collected over the entire study duration of up to 36 days, with individual subject participation of between 15 to 36 days from the signature of the Informed Consent Form (ICF) until the end of the safety follow-up period.
The safety was assessed in the safety population, consisting of all randomized subjects who gave informed consent and had exposure to at least one of the investigational products, including product test, as part of the study.
|
0.00%
0/15 • Adverse events were collected over the entire study duration of up to 36 days, with individual subject participation of between 15 to 36 days from the signature of the Informed Consent Form (ICF) until the end of the safety follow-up period.
The safety was assessed in the safety population, consisting of all randomized subjects who gave informed consent and had exposure to at least one of the investigational products, including product test, as part of the study.
|
0.00%
0/15 • Adverse events were collected over the entire study duration of up to 36 days, with individual subject participation of between 15 to 36 days from the signature of the Informed Consent Form (ICF) until the end of the safety follow-up period.
The safety was assessed in the safety population, consisting of all randomized subjects who gave informed consent and had exposure to at least one of the investigational products, including product test, as part of the study.
|
0.00%
0/15 • Adverse events were collected over the entire study duration of up to 36 days, with individual subject participation of between 15 to 36 days from the signature of the Informed Consent Form (ICF) until the end of the safety follow-up period.
The safety was assessed in the safety population, consisting of all randomized subjects who gave informed consent and had exposure to at least one of the investigational products, including product test, as part of the study.
|
6.7%
1/15 • Number of events 1 • Adverse events were collected over the entire study duration of up to 36 days, with individual subject participation of between 15 to 36 days from the signature of the Informed Consent Form (ICF) until the end of the safety follow-up period.
The safety was assessed in the safety population, consisting of all randomized subjects who gave informed consent and had exposure to at least one of the investigational products, including product test, as part of the study.
|
0.00%
0/15 • Adverse events were collected over the entire study duration of up to 36 days, with individual subject participation of between 15 to 36 days from the signature of the Informed Consent Form (ICF) until the end of the safety follow-up period.
The safety was assessed in the safety population, consisting of all randomized subjects who gave informed consent and had exposure to at least one of the investigational products, including product test, as part of the study.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/15 • Adverse events were collected over the entire study duration of up to 36 days, with individual subject participation of between 15 to 36 days from the signature of the Informed Consent Form (ICF) until the end of the safety follow-up period.
The safety was assessed in the safety population, consisting of all randomized subjects who gave informed consent and had exposure to at least one of the investigational products, including product test, as part of the study.
|
0.00%
0/15 • Adverse events were collected over the entire study duration of up to 36 days, with individual subject participation of between 15 to 36 days from the signature of the Informed Consent Form (ICF) until the end of the safety follow-up period.
The safety was assessed in the safety population, consisting of all randomized subjects who gave informed consent and had exposure to at least one of the investigational products, including product test, as part of the study.
|
6.7%
1/15 • Number of events 1 • Adverse events were collected over the entire study duration of up to 36 days, with individual subject participation of between 15 to 36 days from the signature of the Informed Consent Form (ICF) until the end of the safety follow-up period.
The safety was assessed in the safety population, consisting of all randomized subjects who gave informed consent and had exposure to at least one of the investigational products, including product test, as part of the study.
|
0.00%
0/15 • Adverse events were collected over the entire study duration of up to 36 days, with individual subject participation of between 15 to 36 days from the signature of the Informed Consent Form (ICF) until the end of the safety follow-up period.
The safety was assessed in the safety population, consisting of all randomized subjects who gave informed consent and had exposure to at least one of the investigational products, including product test, as part of the study.
|
0.00%
0/15 • Adverse events were collected over the entire study duration of up to 36 days, with individual subject participation of between 15 to 36 days from the signature of the Informed Consent Form (ICF) until the end of the safety follow-up period.
The safety was assessed in the safety population, consisting of all randomized subjects who gave informed consent and had exposure to at least one of the investigational products, including product test, as part of the study.
|
0.00%
0/15 • Adverse events were collected over the entire study duration of up to 36 days, with individual subject participation of between 15 to 36 days from the signature of the Informed Consent Form (ICF) until the end of the safety follow-up period.
The safety was assessed in the safety population, consisting of all randomized subjects who gave informed consent and had exposure to at least one of the investigational products, including product test, as part of the study.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/15 • Adverse events were collected over the entire study duration of up to 36 days, with individual subject participation of between 15 to 36 days from the signature of the Informed Consent Form (ICF) until the end of the safety follow-up period.
The safety was assessed in the safety population, consisting of all randomized subjects who gave informed consent and had exposure to at least one of the investigational products, including product test, as part of the study.
|
0.00%
0/15 • Adverse events were collected over the entire study duration of up to 36 days, with individual subject participation of between 15 to 36 days from the signature of the Informed Consent Form (ICF) until the end of the safety follow-up period.
The safety was assessed in the safety population, consisting of all randomized subjects who gave informed consent and had exposure to at least one of the investigational products, including product test, as part of the study.
|
6.7%
1/15 • Number of events 1 • Adverse events were collected over the entire study duration of up to 36 days, with individual subject participation of between 15 to 36 days from the signature of the Informed Consent Form (ICF) until the end of the safety follow-up period.
The safety was assessed in the safety population, consisting of all randomized subjects who gave informed consent and had exposure to at least one of the investigational products, including product test, as part of the study.
|
0.00%
0/15 • Adverse events were collected over the entire study duration of up to 36 days, with individual subject participation of between 15 to 36 days from the signature of the Informed Consent Form (ICF) until the end of the safety follow-up period.
The safety was assessed in the safety population, consisting of all randomized subjects who gave informed consent and had exposure to at least one of the investigational products, including product test, as part of the study.
|
0.00%
0/15 • Adverse events were collected over the entire study duration of up to 36 days, with individual subject participation of between 15 to 36 days from the signature of the Informed Consent Form (ICF) until the end of the safety follow-up period.
The safety was assessed in the safety population, consisting of all randomized subjects who gave informed consent and had exposure to at least one of the investigational products, including product test, as part of the study.
|
0.00%
0/15 • Adverse events were collected over the entire study duration of up to 36 days, with individual subject participation of between 15 to 36 days from the signature of the Informed Consent Form (ICF) until the end of the safety follow-up period.
The safety was assessed in the safety population, consisting of all randomized subjects who gave informed consent and had exposure to at least one of the investigational products, including product test, as part of the study.
|
|
Gastrointestinal disorders
Diarrohea
|
0.00%
0/15 • Adverse events were collected over the entire study duration of up to 36 days, with individual subject participation of between 15 to 36 days from the signature of the Informed Consent Form (ICF) until the end of the safety follow-up period.
The safety was assessed in the safety population, consisting of all randomized subjects who gave informed consent and had exposure to at least one of the investigational products, including product test, as part of the study.
|
0.00%
0/15 • Adverse events were collected over the entire study duration of up to 36 days, with individual subject participation of between 15 to 36 days from the signature of the Informed Consent Form (ICF) until the end of the safety follow-up period.
The safety was assessed in the safety population, consisting of all randomized subjects who gave informed consent and had exposure to at least one of the investigational products, including product test, as part of the study.
|
0.00%
0/15 • Adverse events were collected over the entire study duration of up to 36 days, with individual subject participation of between 15 to 36 days from the signature of the Informed Consent Form (ICF) until the end of the safety follow-up period.
The safety was assessed in the safety population, consisting of all randomized subjects who gave informed consent and had exposure to at least one of the investigational products, including product test, as part of the study.
|
0.00%
0/15 • Adverse events were collected over the entire study duration of up to 36 days, with individual subject participation of between 15 to 36 days from the signature of the Informed Consent Form (ICF) until the end of the safety follow-up period.
The safety was assessed in the safety population, consisting of all randomized subjects who gave informed consent and had exposure to at least one of the investigational products, including product test, as part of the study.
|
6.7%
1/15 • Number of events 1 • Adverse events were collected over the entire study duration of up to 36 days, with individual subject participation of between 15 to 36 days from the signature of the Informed Consent Form (ICF) until the end of the safety follow-up period.
The safety was assessed in the safety population, consisting of all randomized subjects who gave informed consent and had exposure to at least one of the investigational products, including product test, as part of the study.
|
0.00%
0/15 • Adverse events were collected over the entire study duration of up to 36 days, with individual subject participation of between 15 to 36 days from the signature of the Informed Consent Form (ICF) until the end of the safety follow-up period.
The safety was assessed in the safety population, consisting of all randomized subjects who gave informed consent and had exposure to at least one of the investigational products, including product test, as part of the study.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/15 • Adverse events were collected over the entire study duration of up to 36 days, with individual subject participation of between 15 to 36 days from the signature of the Informed Consent Form (ICF) until the end of the safety follow-up period.
The safety was assessed in the safety population, consisting of all randomized subjects who gave informed consent and had exposure to at least one of the investigational products, including product test, as part of the study.
|
0.00%
0/15 • Adverse events were collected over the entire study duration of up to 36 days, with individual subject participation of between 15 to 36 days from the signature of the Informed Consent Form (ICF) until the end of the safety follow-up period.
The safety was assessed in the safety population, consisting of all randomized subjects who gave informed consent and had exposure to at least one of the investigational products, including product test, as part of the study.
|
0.00%
0/15 • Adverse events were collected over the entire study duration of up to 36 days, with individual subject participation of between 15 to 36 days from the signature of the Informed Consent Form (ICF) until the end of the safety follow-up period.
The safety was assessed in the safety population, consisting of all randomized subjects who gave informed consent and had exposure to at least one of the investigational products, including product test, as part of the study.
|
0.00%
0/15 • Adverse events were collected over the entire study duration of up to 36 days, with individual subject participation of between 15 to 36 days from the signature of the Informed Consent Form (ICF) until the end of the safety follow-up period.
The safety was assessed in the safety population, consisting of all randomized subjects who gave informed consent and had exposure to at least one of the investigational products, including product test, as part of the study.
|
0.00%
0/15 • Adverse events were collected over the entire study duration of up to 36 days, with individual subject participation of between 15 to 36 days from the signature of the Informed Consent Form (ICF) until the end of the safety follow-up period.
The safety was assessed in the safety population, consisting of all randomized subjects who gave informed consent and had exposure to at least one of the investigational products, including product test, as part of the study.
|
6.7%
1/15 • Number of events 1 • Adverse events were collected over the entire study duration of up to 36 days, with individual subject participation of between 15 to 36 days from the signature of the Informed Consent Form (ICF) until the end of the safety follow-up period.
The safety was assessed in the safety population, consisting of all randomized subjects who gave informed consent and had exposure to at least one of the investigational products, including product test, as part of the study.
|
|
General disorders
Catheter site hypoaesthesia
|
0.00%
0/15 • Adverse events were collected over the entire study duration of up to 36 days, with individual subject participation of between 15 to 36 days from the signature of the Informed Consent Form (ICF) until the end of the safety follow-up period.
The safety was assessed in the safety population, consisting of all randomized subjects who gave informed consent and had exposure to at least one of the investigational products, including product test, as part of the study.
|
6.7%
1/15 • Number of events 1 • Adverse events were collected over the entire study duration of up to 36 days, with individual subject participation of between 15 to 36 days from the signature of the Informed Consent Form (ICF) until the end of the safety follow-up period.
The safety was assessed in the safety population, consisting of all randomized subjects who gave informed consent and had exposure to at least one of the investigational products, including product test, as part of the study.
|
0.00%
0/15 • Adverse events were collected over the entire study duration of up to 36 days, with individual subject participation of between 15 to 36 days from the signature of the Informed Consent Form (ICF) until the end of the safety follow-up period.
The safety was assessed in the safety population, consisting of all randomized subjects who gave informed consent and had exposure to at least one of the investigational products, including product test, as part of the study.
|
0.00%
0/15 • Adverse events were collected over the entire study duration of up to 36 days, with individual subject participation of between 15 to 36 days from the signature of the Informed Consent Form (ICF) until the end of the safety follow-up period.
The safety was assessed in the safety population, consisting of all randomized subjects who gave informed consent and had exposure to at least one of the investigational products, including product test, as part of the study.
|
0.00%
0/15 • Adverse events were collected over the entire study duration of up to 36 days, with individual subject participation of between 15 to 36 days from the signature of the Informed Consent Form (ICF) until the end of the safety follow-up period.
The safety was assessed in the safety population, consisting of all randomized subjects who gave informed consent and had exposure to at least one of the investigational products, including product test, as part of the study.
|
0.00%
0/15 • Adverse events were collected over the entire study duration of up to 36 days, with individual subject participation of between 15 to 36 days from the signature of the Informed Consent Form (ICF) until the end of the safety follow-up period.
The safety was assessed in the safety population, consisting of all randomized subjects who gave informed consent and had exposure to at least one of the investigational products, including product test, as part of the study.
|
|
General disorders
Catheter site inflammation
|
0.00%
0/15 • Adverse events were collected over the entire study duration of up to 36 days, with individual subject participation of between 15 to 36 days from the signature of the Informed Consent Form (ICF) until the end of the safety follow-up period.
The safety was assessed in the safety population, consisting of all randomized subjects who gave informed consent and had exposure to at least one of the investigational products, including product test, as part of the study.
|
0.00%
0/15 • Adverse events were collected over the entire study duration of up to 36 days, with individual subject participation of between 15 to 36 days from the signature of the Informed Consent Form (ICF) until the end of the safety follow-up period.
The safety was assessed in the safety population, consisting of all randomized subjects who gave informed consent and had exposure to at least one of the investigational products, including product test, as part of the study.
|
0.00%
0/15 • Adverse events were collected over the entire study duration of up to 36 days, with individual subject participation of between 15 to 36 days from the signature of the Informed Consent Form (ICF) until the end of the safety follow-up period.
The safety was assessed in the safety population, consisting of all randomized subjects who gave informed consent and had exposure to at least one of the investigational products, including product test, as part of the study.
|
0.00%
0/15 • Adverse events were collected over the entire study duration of up to 36 days, with individual subject participation of between 15 to 36 days from the signature of the Informed Consent Form (ICF) until the end of the safety follow-up period.
The safety was assessed in the safety population, consisting of all randomized subjects who gave informed consent and had exposure to at least one of the investigational products, including product test, as part of the study.
|
6.7%
1/15 • Number of events 1 • Adverse events were collected over the entire study duration of up to 36 days, with individual subject participation of between 15 to 36 days from the signature of the Informed Consent Form (ICF) until the end of the safety follow-up period.
The safety was assessed in the safety population, consisting of all randomized subjects who gave informed consent and had exposure to at least one of the investigational products, including product test, as part of the study.
|
0.00%
0/15 • Adverse events were collected over the entire study duration of up to 36 days, with individual subject participation of between 15 to 36 days from the signature of the Informed Consent Form (ICF) until the end of the safety follow-up period.
The safety was assessed in the safety population, consisting of all randomized subjects who gave informed consent and had exposure to at least one of the investigational products, including product test, as part of the study.
|
|
General disorders
Catheter site pain
|
0.00%
0/15 • Adverse events were collected over the entire study duration of up to 36 days, with individual subject participation of between 15 to 36 days from the signature of the Informed Consent Form (ICF) until the end of the safety follow-up period.
The safety was assessed in the safety population, consisting of all randomized subjects who gave informed consent and had exposure to at least one of the investigational products, including product test, as part of the study.
|
6.7%
1/15 • Number of events 1 • Adverse events were collected over the entire study duration of up to 36 days, with individual subject participation of between 15 to 36 days from the signature of the Informed Consent Form (ICF) until the end of the safety follow-up period.
The safety was assessed in the safety population, consisting of all randomized subjects who gave informed consent and had exposure to at least one of the investigational products, including product test, as part of the study.
|
0.00%
0/15 • Adverse events were collected over the entire study duration of up to 36 days, with individual subject participation of between 15 to 36 days from the signature of the Informed Consent Form (ICF) until the end of the safety follow-up period.
The safety was assessed in the safety population, consisting of all randomized subjects who gave informed consent and had exposure to at least one of the investigational products, including product test, as part of the study.
|
0.00%
0/15 • Adverse events were collected over the entire study duration of up to 36 days, with individual subject participation of between 15 to 36 days from the signature of the Informed Consent Form (ICF) until the end of the safety follow-up period.
The safety was assessed in the safety population, consisting of all randomized subjects who gave informed consent and had exposure to at least one of the investigational products, including product test, as part of the study.
|
0.00%
0/15 • Adverse events were collected over the entire study duration of up to 36 days, with individual subject participation of between 15 to 36 days from the signature of the Informed Consent Form (ICF) until the end of the safety follow-up period.
The safety was assessed in the safety population, consisting of all randomized subjects who gave informed consent and had exposure to at least one of the investigational products, including product test, as part of the study.
|
0.00%
0/15 • Adverse events were collected over the entire study duration of up to 36 days, with individual subject participation of between 15 to 36 days from the signature of the Informed Consent Form (ICF) until the end of the safety follow-up period.
The safety was assessed in the safety population, consisting of all randomized subjects who gave informed consent and had exposure to at least one of the investigational products, including product test, as part of the study.
|
|
Nervous system disorders
Presyncope
|
6.7%
1/15 • Number of events 1 • Adverse events were collected over the entire study duration of up to 36 days, with individual subject participation of between 15 to 36 days from the signature of the Informed Consent Form (ICF) until the end of the safety follow-up period.
The safety was assessed in the safety population, consisting of all randomized subjects who gave informed consent and had exposure to at least one of the investigational products, including product test, as part of the study.
|
0.00%
0/15 • Adverse events were collected over the entire study duration of up to 36 days, with individual subject participation of between 15 to 36 days from the signature of the Informed Consent Form (ICF) until the end of the safety follow-up period.
The safety was assessed in the safety population, consisting of all randomized subjects who gave informed consent and had exposure to at least one of the investigational products, including product test, as part of the study.
|
0.00%
0/15 • Adverse events were collected over the entire study duration of up to 36 days, with individual subject participation of between 15 to 36 days from the signature of the Informed Consent Form (ICF) until the end of the safety follow-up period.
The safety was assessed in the safety population, consisting of all randomized subjects who gave informed consent and had exposure to at least one of the investigational products, including product test, as part of the study.
|
0.00%
0/15 • Adverse events were collected over the entire study duration of up to 36 days, with individual subject participation of between 15 to 36 days from the signature of the Informed Consent Form (ICF) until the end of the safety follow-up period.
The safety was assessed in the safety population, consisting of all randomized subjects who gave informed consent and had exposure to at least one of the investigational products, including product test, as part of the study.
|
0.00%
0/15 • Adverse events were collected over the entire study duration of up to 36 days, with individual subject participation of between 15 to 36 days from the signature of the Informed Consent Form (ICF) until the end of the safety follow-up period.
The safety was assessed in the safety population, consisting of all randomized subjects who gave informed consent and had exposure to at least one of the investigational products, including product test, as part of the study.
|
0.00%
0/15 • Adverse events were collected over the entire study duration of up to 36 days, with individual subject participation of between 15 to 36 days from the signature of the Informed Consent Form (ICF) until the end of the safety follow-up period.
The safety was assessed in the safety population, consisting of all randomized subjects who gave informed consent and had exposure to at least one of the investigational products, including product test, as part of the study.
|
|
Nervous system disorders
Syncope
|
0.00%
0/15 • Adverse events were collected over the entire study duration of up to 36 days, with individual subject participation of between 15 to 36 days from the signature of the Informed Consent Form (ICF) until the end of the safety follow-up period.
The safety was assessed in the safety population, consisting of all randomized subjects who gave informed consent and had exposure to at least one of the investigational products, including product test, as part of the study.
|
0.00%
0/15 • Adverse events were collected over the entire study duration of up to 36 days, with individual subject participation of between 15 to 36 days from the signature of the Informed Consent Form (ICF) until the end of the safety follow-up period.
The safety was assessed in the safety population, consisting of all randomized subjects who gave informed consent and had exposure to at least one of the investigational products, including product test, as part of the study.
|
0.00%
0/15 • Adverse events were collected over the entire study duration of up to 36 days, with individual subject participation of between 15 to 36 days from the signature of the Informed Consent Form (ICF) until the end of the safety follow-up period.
The safety was assessed in the safety population, consisting of all randomized subjects who gave informed consent and had exposure to at least one of the investigational products, including product test, as part of the study.
|
0.00%
0/15 • Adverse events were collected over the entire study duration of up to 36 days, with individual subject participation of between 15 to 36 days from the signature of the Informed Consent Form (ICF) until the end of the safety follow-up period.
The safety was assessed in the safety population, consisting of all randomized subjects who gave informed consent and had exposure to at least one of the investigational products, including product test, as part of the study.
|
6.7%
1/15 • Number of events 1 • Adverse events were collected over the entire study duration of up to 36 days, with individual subject participation of between 15 to 36 days from the signature of the Informed Consent Form (ICF) until the end of the safety follow-up period.
The safety was assessed in the safety population, consisting of all randomized subjects who gave informed consent and had exposure to at least one of the investigational products, including product test, as part of the study.
|
0.00%
0/15 • Adverse events were collected over the entire study duration of up to 36 days, with individual subject participation of between 15 to 36 days from the signature of the Informed Consent Form (ICF) until the end of the safety follow-up period.
The safety was assessed in the safety population, consisting of all randomized subjects who gave informed consent and had exposure to at least one of the investigational products, including product test, as part of the study.
|
|
Vascular disorders
Phlebitis
|
0.00%
0/15 • Adverse events were collected over the entire study duration of up to 36 days, with individual subject participation of between 15 to 36 days from the signature of the Informed Consent Form (ICF) until the end of the safety follow-up period.
The safety was assessed in the safety population, consisting of all randomized subjects who gave informed consent and had exposure to at least one of the investigational products, including product test, as part of the study.
|
0.00%
0/15 • Adverse events were collected over the entire study duration of up to 36 days, with individual subject participation of between 15 to 36 days from the signature of the Informed Consent Form (ICF) until the end of the safety follow-up period.
The safety was assessed in the safety population, consisting of all randomized subjects who gave informed consent and had exposure to at least one of the investigational products, including product test, as part of the study.
|
0.00%
0/15 • Adverse events were collected over the entire study duration of up to 36 days, with individual subject participation of between 15 to 36 days from the signature of the Informed Consent Form (ICF) until the end of the safety follow-up period.
The safety was assessed in the safety population, consisting of all randomized subjects who gave informed consent and had exposure to at least one of the investigational products, including product test, as part of the study.
|
0.00%
0/15 • Adverse events were collected over the entire study duration of up to 36 days, with individual subject participation of between 15 to 36 days from the signature of the Informed Consent Form (ICF) until the end of the safety follow-up period.
The safety was assessed in the safety population, consisting of all randomized subjects who gave informed consent and had exposure to at least one of the investigational products, including product test, as part of the study.
|
0.00%
0/15 • Adverse events were collected over the entire study duration of up to 36 days, with individual subject participation of between 15 to 36 days from the signature of the Informed Consent Form (ICF) until the end of the safety follow-up period.
The safety was assessed in the safety population, consisting of all randomized subjects who gave informed consent and had exposure to at least one of the investigational products, including product test, as part of the study.
|
6.7%
1/15 • Number of events 1 • Adverse events were collected over the entire study duration of up to 36 days, with individual subject participation of between 15 to 36 days from the signature of the Informed Consent Form (ICF) until the end of the safety follow-up period.
The safety was assessed in the safety population, consisting of all randomized subjects who gave informed consent and had exposure to at least one of the investigational products, including product test, as part of the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee We confirm we have the contractual provisions in place which specify that in no event will the study site be allowed to disclose to any third party (or publicly release) any information obtained through the study without the CRO's prior written consent which in turn cannot provide such consent without Sponsor's approval unless such publication is made to satisfy regulatory requirements. The Intellectual Property rights and research results from the present study belong to the Sponsor.
- Publication restrictions are in place
Restriction type: OTHER