Trial Outcomes & Findings for Single Blind Cross-over Dose Response Study in Subjects of Two Inhalers of Salmeterol and Fluticasone Propionate (NCT NCT02232087)
NCT ID: NCT02232087
Last Updated: 2022-06-15
Results Overview
Selection of steepest part of dose response curve for Relative Potency: 6 and 12 inhalation dose pairs. Slope of B and C line compared with slope of E and F to obtain relative potency value. Two inhalation dose not utilized as not on steepest part of curve.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
52 participants
Primary outcome timeframe
Baseline, up to 6 hrs
Results posted on
2022-06-15
Participant Flow
Recruitment began 07 July 2014
Participant milestones
| Measure |
Sequence 1 (A, F, B, E, C, D)
salmeterol and fluticasone propionate per inhalation
A = 2 inhalations (test product), B = 6 inhalations (test product), C = 12 inhalations (test product), D = 2 inhalations (reference product), E = 6 inhalations (reference product) and F = 12 inhalations (reference product)
|
Sequence 2 (B, A, C, F, D, E)
salmeterol and fluticasone propionate per inhalation
A = 2 inhalations (test product), B = 6 inhalations (test product), C = 12 inhalations (test product), D = 2 inhalations (reference product), E = 6 inhalations (reference product) and F = 12 inhalations (reference product)
|
Sequence 3 (C, B, D, A, E, F)
salmeterol and fluticasone propionate per inhalation
A = 2 inhalations (test product), B = 6 inhalations (test product), C = 12 inhalations (test product), D = 2 inhalations (reference product), E = 6 inhalations (reference product) and F = 12 inhalations (reference product)
|
Sequence 4 (D, C, E, B, F, A)
salmeterol and fluticasone propionate per inhalation
A = 2 inhalations (test product), B = 6 inhalations (test product), C = 12 inhalations (test product), D = 2 inhalations (reference product), E = 6 inhalations (reference product) and F = 12 inhalations (reference product)
|
Sequence 5 (E, D, F, C, A, B)
salmeterol and fluticasone propionate per inhalation
A = 2 inhalations (test product), B = 6 inhalations (test product), C = 12 inhalations (test product), D = 2 inhalations (reference product), E = 6 inhalations (reference product) and F = 12 inhalations (reference product)
|
Sequence 6 (F, E, A, D, B, C )
salmeterol and fluticasone propionate per inhalation
A = 2 inhalations (test product), B = 6 inhalations (test product), C = 12 inhalations (test product), D = 2 inhalations (reference product), E = 6 inhalations (reference product) and F = 12 inhalations (reference product)
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
9
|
10
|
8
|
8
|
8
|
9
|
|
Overall Study
COMPLETED
|
7
|
8
|
8
|
7
|
7
|
6
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
0
|
1
|
1
|
3
|
Reasons for withdrawal
| Measure |
Sequence 1 (A, F, B, E, C, D)
salmeterol and fluticasone propionate per inhalation
A = 2 inhalations (test product), B = 6 inhalations (test product), C = 12 inhalations (test product), D = 2 inhalations (reference product), E = 6 inhalations (reference product) and F = 12 inhalations (reference product)
|
Sequence 2 (B, A, C, F, D, E)
salmeterol and fluticasone propionate per inhalation
A = 2 inhalations (test product), B = 6 inhalations (test product), C = 12 inhalations (test product), D = 2 inhalations (reference product), E = 6 inhalations (reference product) and F = 12 inhalations (reference product)
|
Sequence 3 (C, B, D, A, E, F)
salmeterol and fluticasone propionate per inhalation
A = 2 inhalations (test product), B = 6 inhalations (test product), C = 12 inhalations (test product), D = 2 inhalations (reference product), E = 6 inhalations (reference product) and F = 12 inhalations (reference product)
|
Sequence 4 (D, C, E, B, F, A)
salmeterol and fluticasone propionate per inhalation
A = 2 inhalations (test product), B = 6 inhalations (test product), C = 12 inhalations (test product), D = 2 inhalations (reference product), E = 6 inhalations (reference product) and F = 12 inhalations (reference product)
|
Sequence 5 (E, D, F, C, A, B)
salmeterol and fluticasone propionate per inhalation
A = 2 inhalations (test product), B = 6 inhalations (test product), C = 12 inhalations (test product), D = 2 inhalations (reference product), E = 6 inhalations (reference product) and F = 12 inhalations (reference product)
|
Sequence 6 (F, E, A, D, B, C )
salmeterol and fluticasone propionate per inhalation
A = 2 inhalations (test product), B = 6 inhalations (test product), C = 12 inhalations (test product), D = 2 inhalations (reference product), E = 6 inhalations (reference product) and F = 12 inhalations (reference product)
|
|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
poor inhalation technique
|
0
|
1
|
0
|
0
|
0
|
2
|
|
Overall Study
protocol stop criteria
|
0
|
1
|
0
|
1
|
0
|
0
|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Single Blind Cross-over Dose Response Study in Subjects of Two Inhalers of Salmeterol and Fluticasone Propionate
Baseline characteristics by cohort
| Measure |
All Subjects
n=52 Participants
salmeterol and fluticasone propionate
|
|---|---|
|
Age, Continuous
|
33.5 years
STANDARD_DEVIATION 10.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 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
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
46 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
52 participants
n=5 Participants
|
|
BMI
|
23.6 kg/m2
STANDARD_DEVIATION 1.8 • n=5 Participants
|
|
forced expiratory volume at one second
|
101.19 % predicted normal
STANDARD_DEVIATION 10.74 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, up to 6 hrsPopulation: relative potency calculated for dose pairs B (6 inhalations) and C (12 inhalations), compared with E (6 inhalations) and F (12 inhalations)
Selection of steepest part of dose response curve for Relative Potency: 6 and 12 inhalation dose pairs. Slope of B and C line compared with slope of E and F to obtain relative potency value. Two inhalation dose not utilized as not on steepest part of curve.
Outcome measures
| Measure |
Test B and C vs Reference E and F
n=42 Participants
salmeterol and fluticasone propionate
Salmeterol: B, E 6 puffs; C, F 12 puffs
fluticasone propionate: B, E 6 puffs; C, F 12 puffs
|
Reference Product D
salmeterol and fluticasone propionate
salmeterol (as salmeterol xinafoate): 2 inhalations
fluticasone propionate: 2 inhalations
|
Test Product B
salmeterol and fluticasone propionate
salmeterol (as salmeterol xinafoate): 6 inhalations
fluticasone propionate: 6 inhalations
|
Reference Product E
salmeterol and fluticasone propionate
salmeterol (as salmeterol xinafoate): 6 inhalations
fluticasone propionate: 6 inhalations
|
Test Product C
salmeterol and fluticasone propionate
salmeterol (as salmeterol xinafoate): 12 inhalations
fluticasone propionate: 12 inhalations
|
Reference Product F
salmeterol and fluticasone propionate
salmeterol (as salmeterol xinafoate):12 inhalations
fluticasone propionate: 12 inhalations
|
|---|---|---|---|---|---|---|
|
Relative Potency Max Heart Rate
|
0.8619 unitless
Interval 0.7209 to 1.0
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline up to 6 hrsPopulation: relative potency calculated for dose pairs A (2 inhalations) and B (6 inhalations), compared with D (2 inhalations) and E (6 inhalations)
Selection of steepest part of dose response curve for Relative Potency: 2 and 6 inhalation dose pairs. Slope of A and B line compared with slope of D and E to obtain relative potency value. Twelve inhalation dose not utilized as not on steepest part of curve.
Outcome measures
| Measure |
Test B and C vs Reference E and F
n=42 Participants
salmeterol and fluticasone propionate
Salmeterol: B, E 6 puffs; C, F 12 puffs
fluticasone propionate: B, E 6 puffs; C, F 12 puffs
|
Reference Product D
salmeterol and fluticasone propionate
salmeterol (as salmeterol xinafoate): 2 inhalations
fluticasone propionate: 2 inhalations
|
Test Product B
salmeterol and fluticasone propionate
salmeterol (as salmeterol xinafoate): 6 inhalations
fluticasone propionate: 6 inhalations
|
Reference Product E
salmeterol and fluticasone propionate
salmeterol (as salmeterol xinafoate): 6 inhalations
fluticasone propionate: 6 inhalations
|
Test Product C
salmeterol and fluticasone propionate
salmeterol (as salmeterol xinafoate): 12 inhalations
fluticasone propionate: 12 inhalations
|
Reference Product F
salmeterol and fluticasone propionate
salmeterol (as salmeterol xinafoate):12 inhalations
fluticasone propionate: 12 inhalations
|
|---|---|---|---|---|---|---|
|
Relative Potency QTcB Interval
|
1.0760 unitless
Interval 0.8206 to 1.4238
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline through 6 hoursPopulation: subjects who received the test and the reference product at the 2, 6, or 12 inhalations dose
max heart rate at the 2, 6, or 12 inhalations dose, assessed at multiple times over 6 hours
Outcome measures
| Measure |
Test B and C vs Reference E and F
n=43 Participants
salmeterol and fluticasone propionate
Salmeterol: B, E 6 puffs; C, F 12 puffs
fluticasone propionate: B, E 6 puffs; C, F 12 puffs
|
Reference Product D
n=43 Participants
salmeterol and fluticasone propionate
salmeterol (as salmeterol xinafoate): 2 inhalations
fluticasone propionate: 2 inhalations
|
Test Product B
n=45 Participants
salmeterol and fluticasone propionate
salmeterol (as salmeterol xinafoate): 6 inhalations
fluticasone propionate: 6 inhalations
|
Reference Product E
n=45 Participants
salmeterol and fluticasone propionate
salmeterol (as salmeterol xinafoate): 6 inhalations
fluticasone propionate: 6 inhalations
|
Test Product C
n=44 Participants
salmeterol and fluticasone propionate
salmeterol (as salmeterol xinafoate): 12 inhalations
fluticasone propionate: 12 inhalations
|
Reference Product F
n=46 Participants
salmeterol and fluticasone propionate
salmeterol (as salmeterol xinafoate):12 inhalations
fluticasone propionate: 12 inhalations
|
|---|---|---|---|---|---|---|
|
Max Heart Rate
|
65.1 bpm
Standard Deviation 10.9
|
65.5 bpm
Standard Deviation 10.1
|
68.9 bpm
Standard Deviation 11.0
|
69.9 bpm
Standard Deviation 12.2
|
75.3 bpm
Standard Deviation 13.3
|
76.8 bpm
Standard Deviation 14.8
|
SECONDARY outcome
Timeframe: baseline through 6 hoursPopulation: subjects who received both the test and reference products at the 2, 6, or 12 inhalations dose
maximum plasma levels of potassium at 2, 6 or 12 inhalations dose inhalations dose, assessed a multiple times over 6 hours.
Outcome measures
| Measure |
Test B and C vs Reference E and F
n=43 Participants
salmeterol and fluticasone propionate
Salmeterol: B, E 6 puffs; C, F 12 puffs
fluticasone propionate: B, E 6 puffs; C, F 12 puffs
|
Reference Product D
n=43 Participants
salmeterol and fluticasone propionate
salmeterol (as salmeterol xinafoate): 2 inhalations
fluticasone propionate: 2 inhalations
|
Test Product B
n=45 Participants
salmeterol and fluticasone propionate
salmeterol (as salmeterol xinafoate): 6 inhalations
fluticasone propionate: 6 inhalations
|
Reference Product E
n=45 Participants
salmeterol and fluticasone propionate
salmeterol (as salmeterol xinafoate): 6 inhalations
fluticasone propionate: 6 inhalations
|
Test Product C
n=44 Participants
salmeterol and fluticasone propionate
salmeterol (as salmeterol xinafoate): 12 inhalations
fluticasone propionate: 12 inhalations
|
Reference Product F
n=46 Participants
salmeterol and fluticasone propionate
salmeterol (as salmeterol xinafoate):12 inhalations
fluticasone propionate: 12 inhalations
|
|---|---|---|---|---|---|---|
|
Plasma Potassium Level
|
3.82 mmol/L
Standard Deviation 0.19
|
3.78 mmol/L
Standard Deviation 0.16
|
3.76 mmol/L
Standard Deviation 0.20
|
3.75 mmol/L
Standard Deviation 0.19
|
3.63 mmol/L
Standard Deviation 0.24
|
3.61 mmol/L
Standard Deviation 0.26
|
SECONDARY outcome
Timeframe: baseline through 6 hoursPopulation: subjects who received both the test and reference products at the two inhalations dose
maximum levels of glucose at the 2, 6 or 12 inhalations dose, assessed at multiple times over 6 hours.
Outcome measures
| Measure |
Test B and C vs Reference E and F
n=43 Participants
salmeterol and fluticasone propionate
Salmeterol: B, E 6 puffs; C, F 12 puffs
fluticasone propionate: B, E 6 puffs; C, F 12 puffs
|
Reference Product D
n=43 Participants
salmeterol and fluticasone propionate
salmeterol (as salmeterol xinafoate): 2 inhalations
fluticasone propionate: 2 inhalations
|
Test Product B
n=45 Participants
salmeterol and fluticasone propionate
salmeterol (as salmeterol xinafoate): 6 inhalations
fluticasone propionate: 6 inhalations
|
Reference Product E
n=45 Participants
salmeterol and fluticasone propionate
salmeterol (as salmeterol xinafoate): 6 inhalations
fluticasone propionate: 6 inhalations
|
Test Product C
n=44 Participants
salmeterol and fluticasone propionate
salmeterol (as salmeterol xinafoate): 12 inhalations
fluticasone propionate: 12 inhalations
|
Reference Product F
n=46 Participants
salmeterol and fluticasone propionate
salmeterol (as salmeterol xinafoate):12 inhalations
fluticasone propionate: 12 inhalations
|
|---|---|---|---|---|---|---|
|
Max Plasma Glucose Level
|
5.31 mmol/L
Standard Deviation 0.49
|
5.31 mmol/L
Standard Deviation 0.40
|
5.53 mmol/L
Standard Deviation 0.65
|
5.62 mmol/L
Standard Deviation 0.54
|
5.88 mmol/L
Standard Deviation 0.66
|
5.98 mmol/L
Standard Deviation 0.65
|
SECONDARY outcome
Timeframe: Baseline through 6 hoursPopulation: all subjects who received the test and the reference product at the two inhalations dose
For each dose, the 95% CIs for the mean difference for the test product versus the reference product were calculated.
Outcome measures
| Measure |
Test B and C vs Reference E and F
n=43 Participants
salmeterol and fluticasone propionate
Salmeterol: B, E 6 puffs; C, F 12 puffs
fluticasone propionate: B, E 6 puffs; C, F 12 puffs
|
Reference Product D
n=43 Participants
salmeterol and fluticasone propionate
salmeterol (as salmeterol xinafoate): 2 inhalations
fluticasone propionate: 2 inhalations
|
Test Product B
n=45 Participants
salmeterol and fluticasone propionate
salmeterol (as salmeterol xinafoate): 6 inhalations
fluticasone propionate: 6 inhalations
|
Reference Product E
n=45 Participants
salmeterol and fluticasone propionate
salmeterol (as salmeterol xinafoate): 6 inhalations
fluticasone propionate: 6 inhalations
|
Test Product C
n=44 Participants
salmeterol and fluticasone propionate
salmeterol (as salmeterol xinafoate): 12 inhalations
fluticasone propionate: 12 inhalations
|
Reference Product F
n=46 Participants
salmeterol and fluticasone propionate
salmeterol (as salmeterol xinafoate):12 inhalations
fluticasone propionate: 12 inhalations
|
|---|---|---|---|---|---|---|
|
Max QTcB
|
422.3 ms
Standard Deviation 22.4
|
422.1 ms
Standard Deviation 23.7
|
430.0 ms
Standard Deviation 23.1
|
430.2 ms
Standard Deviation 21.4
|
441.0 ms
Standard Deviation 20.5
|
444.0 ms
Standard Deviation 26.7
|
Adverse Events
Test Product A
Serious events: 0 serious events
Other events: 4 other events
Deaths: 4 deaths
Test Product B
Serious events: 0 serious events
Other events: 5 other events
Deaths: 5 deaths
Test Product C
Serious events: 0 serious events
Other events: 11 other events
Deaths: 11 deaths
Reference Product D
Serious events: 0 serious events
Other events: 5 other events
Deaths: 5 deaths
Reference Product E
Serious events: 0 serious events
Other events: 4 other events
Deaths: 4 deaths
Referencet Product F
Serious events: 0 serious events
Other events: 8 other events
Deaths: 8 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Test Product A
n=49 participants at risk
salmeterol and fluticasone propionate
salmeterol (as salmeterol xinafoate): 2 inhalations
fluticasone propionate: 2 inhalations
|
Test Product B
n=48 participants at risk
salmeterol and fluticasone propionate
salmeterol (as salmeterol xinafoate): 6 inhalations
fluticasone propionate: 6 inhalations
|
Test Product C
n=47 participants at risk
salmeterol and fluticasone propionate
salmeterol (as salmeterol xinafoate): 12 inhalations
fluticasone propionate: 12 inhalations
|
Reference Product D
n=47 participants at risk
salmeterol and fluticasone propionate
salmeterol (as salmeterol xinafoate): 6 inhalations
fluticasone propionate: 6 inhalations
|
Reference Product E
n=48 participants at risk
salmeterol and fluticasone propionate
salmeterol (as salmeterol xinafoate): 12 inhalations
fluticasone propionate: 12 inhalations
|
Referencet Product F
n=50 participants at risk
salmeterol and fluticasone propionate
|
|---|---|---|---|---|---|---|
|
Nervous system disorders
headache
|
4.1%
2/49 • Adverse events were collected for up to 2 months for each subject. The duration of the clinical phase of the study was 4 months.
All subjects who received a dose of at least one product
|
4.2%
2/48 • Adverse events were collected for up to 2 months for each subject. The duration of the clinical phase of the study was 4 months.
All subjects who received a dose of at least one product
|
8.5%
4/47 • Adverse events were collected for up to 2 months for each subject. The duration of the clinical phase of the study was 4 months.
All subjects who received a dose of at least one product
|
6.4%
3/47 • Adverse events were collected for up to 2 months for each subject. The duration of the clinical phase of the study was 4 months.
All subjects who received a dose of at least one product
|
8.3%
4/48 • Adverse events were collected for up to 2 months for each subject. The duration of the clinical phase of the study was 4 months.
All subjects who received a dose of at least one product
|
8.0%
4/50 • Adverse events were collected for up to 2 months for each subject. The duration of the clinical phase of the study was 4 months.
All subjects who received a dose of at least one product
|
|
General disorders
Asthenia
|
2.0%
1/49 • Adverse events were collected for up to 2 months for each subject. The duration of the clinical phase of the study was 4 months.
All subjects who received a dose of at least one product
|
0.00%
0/48 • Adverse events were collected for up to 2 months for each subject. The duration of the clinical phase of the study was 4 months.
All subjects who received a dose of at least one product
|
0.00%
0/47 • Adverse events were collected for up to 2 months for each subject. The duration of the clinical phase of the study was 4 months.
All subjects who received a dose of at least one product
|
0.00%
0/47 • Adverse events were collected for up to 2 months for each subject. The duration of the clinical phase of the study was 4 months.
All subjects who received a dose of at least one product
|
0.00%
0/48 • Adverse events were collected for up to 2 months for each subject. The duration of the clinical phase of the study was 4 months.
All subjects who received a dose of at least one product
|
0.00%
0/50 • Adverse events were collected for up to 2 months for each subject. The duration of the clinical phase of the study was 4 months.
All subjects who received a dose of at least one product
|
|
General disorders
Fatigue
|
2.0%
1/49 • Adverse events were collected for up to 2 months for each subject. The duration of the clinical phase of the study was 4 months.
All subjects who received a dose of at least one product
|
0.00%
0/48 • Adverse events were collected for up to 2 months for each subject. The duration of the clinical phase of the study was 4 months.
All subjects who received a dose of at least one product
|
0.00%
0/47 • Adverse events were collected for up to 2 months for each subject. The duration of the clinical phase of the study was 4 months.
All subjects who received a dose of at least one product
|
0.00%
0/47 • Adverse events were collected for up to 2 months for each subject. The duration of the clinical phase of the study was 4 months.
All subjects who received a dose of at least one product
|
0.00%
0/48 • Adverse events were collected for up to 2 months for each subject. The duration of the clinical phase of the study was 4 months.
All subjects who received a dose of at least one product
|
0.00%
0/50 • Adverse events were collected for up to 2 months for each subject. The duration of the clinical phase of the study was 4 months.
All subjects who received a dose of at least one product
|
|
Gastrointestinal disorders
Mouth Ulceration
|
2.0%
1/49 • Adverse events were collected for up to 2 months for each subject. The duration of the clinical phase of the study was 4 months.
All subjects who received a dose of at least one product
|
0.00%
0/48 • Adverse events were collected for up to 2 months for each subject. The duration of the clinical phase of the study was 4 months.
All subjects who received a dose of at least one product
|
0.00%
0/47 • Adverse events were collected for up to 2 months for each subject. The duration of the clinical phase of the study was 4 months.
All subjects who received a dose of at least one product
|
0.00%
0/47 • Adverse events were collected for up to 2 months for each subject. The duration of the clinical phase of the study was 4 months.
All subjects who received a dose of at least one product
|
2.1%
1/48 • Adverse events were collected for up to 2 months for each subject. The duration of the clinical phase of the study was 4 months.
All subjects who received a dose of at least one product
|
0.00%
0/50 • Adverse events were collected for up to 2 months for each subject. The duration of the clinical phase of the study was 4 months.
All subjects who received a dose of at least one product
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/49 • Adverse events were collected for up to 2 months for each subject. The duration of the clinical phase of the study was 4 months.
All subjects who received a dose of at least one product
|
0.00%
0/48 • Adverse events were collected for up to 2 months for each subject. The duration of the clinical phase of the study was 4 months.
All subjects who received a dose of at least one product
|
0.00%
0/47 • Adverse events were collected for up to 2 months for each subject. The duration of the clinical phase of the study was 4 months.
All subjects who received a dose of at least one product
|
2.1%
1/47 • Adverse events were collected for up to 2 months for each subject. The duration of the clinical phase of the study was 4 months.
All subjects who received a dose of at least one product
|
0.00%
0/48 • Adverse events were collected for up to 2 months for each subject. The duration of the clinical phase of the study was 4 months.
All subjects who received a dose of at least one product
|
0.00%
0/50 • Adverse events were collected for up to 2 months for each subject. The duration of the clinical phase of the study was 4 months.
All subjects who received a dose of at least one product
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/49 • Adverse events were collected for up to 2 months for each subject. The duration of the clinical phase of the study was 4 months.
All subjects who received a dose of at least one product
|
0.00%
0/48 • Adverse events were collected for up to 2 months for each subject. The duration of the clinical phase of the study was 4 months.
All subjects who received a dose of at least one product
|
0.00%
0/47 • Adverse events were collected for up to 2 months for each subject. The duration of the clinical phase of the study was 4 months.
All subjects who received a dose of at least one product
|
0.00%
0/47 • Adverse events were collected for up to 2 months for each subject. The duration of the clinical phase of the study was 4 months.
All subjects who received a dose of at least one product
|
2.1%
1/48 • Adverse events were collected for up to 2 months for each subject. The duration of the clinical phase of the study was 4 months.
All subjects who received a dose of at least one product
|
2.0%
1/50 • Adverse events were collected for up to 2 months for each subject. The duration of the clinical phase of the study was 4 months.
All subjects who received a dose of at least one product
|
|
General disorders
Feeling Hot
|
0.00%
0/49 • Adverse events were collected for up to 2 months for each subject. The duration of the clinical phase of the study was 4 months.
All subjects who received a dose of at least one product
|
0.00%
0/48 • Adverse events were collected for up to 2 months for each subject. The duration of the clinical phase of the study was 4 months.
All subjects who received a dose of at least one product
|
0.00%
0/47 • Adverse events were collected for up to 2 months for each subject. The duration of the clinical phase of the study was 4 months.
All subjects who received a dose of at least one product
|
0.00%
0/47 • Adverse events were collected for up to 2 months for each subject. The duration of the clinical phase of the study was 4 months.
All subjects who received a dose of at least one product
|
2.1%
1/48 • Adverse events were collected for up to 2 months for each subject. The duration of the clinical phase of the study was 4 months.
All subjects who received a dose of at least one product
|
4.0%
2/50 • Adverse events were collected for up to 2 months for each subject. The duration of the clinical phase of the study was 4 months.
All subjects who received a dose of at least one product
|
|
General disorders
Feeling Cold
|
0.00%
0/49 • Adverse events were collected for up to 2 months for each subject. The duration of the clinical phase of the study was 4 months.
All subjects who received a dose of at least one product
|
0.00%
0/48 • Adverse events were collected for up to 2 months for each subject. The duration of the clinical phase of the study was 4 months.
All subjects who received a dose of at least one product
|
2.1%
1/47 • Adverse events were collected for up to 2 months for each subject. The duration of the clinical phase of the study was 4 months.
All subjects who received a dose of at least one product
|
0.00%
0/47 • Adverse events were collected for up to 2 months for each subject. The duration of the clinical phase of the study was 4 months.
All subjects who received a dose of at least one product
|
0.00%
0/48 • Adverse events were collected for up to 2 months for each subject. The duration of the clinical phase of the study was 4 months.
All subjects who received a dose of at least one product
|
0.00%
0/50 • Adverse events were collected for up to 2 months for each subject. The duration of the clinical phase of the study was 4 months.
All subjects who received a dose of at least one product
|
|
Investigations
ECG QT prolonged
|
0.00%
0/49 • Adverse events were collected for up to 2 months for each subject. The duration of the clinical phase of the study was 4 months.
All subjects who received a dose of at least one product
|
0.00%
0/48 • Adverse events were collected for up to 2 months for each subject. The duration of the clinical phase of the study was 4 months.
All subjects who received a dose of at least one product
|
2.1%
1/47 • Adverse events were collected for up to 2 months for each subject. The duration of the clinical phase of the study was 4 months.
All subjects who received a dose of at least one product
|
0.00%
0/47 • Adverse events were collected for up to 2 months for each subject. The duration of the clinical phase of the study was 4 months.
All subjects who received a dose of at least one product
|
0.00%
0/48 • Adverse events were collected for up to 2 months for each subject. The duration of the clinical phase of the study was 4 months.
All subjects who received a dose of at least one product
|
2.0%
1/50 • Adverse events were collected for up to 2 months for each subject. The duration of the clinical phase of the study was 4 months.
All subjects who received a dose of at least one product
|
|
Investigations
Prolongation
|
0.00%
0/49 • Adverse events were collected for up to 2 months for each subject. The duration of the clinical phase of the study was 4 months.
All subjects who received a dose of at least one product
|
0.00%
0/48 • Adverse events were collected for up to 2 months for each subject. The duration of the clinical phase of the study was 4 months.
All subjects who received a dose of at least one product
|
2.1%
1/47 • Adverse events were collected for up to 2 months for each subject. The duration of the clinical phase of the study was 4 months.
All subjects who received a dose of at least one product
|
0.00%
0/47 • Adverse events were collected for up to 2 months for each subject. The duration of the clinical phase of the study was 4 months.
All subjects who received a dose of at least one product
|
0.00%
0/48 • Adverse events were collected for up to 2 months for each subject. The duration of the clinical phase of the study was 4 months.
All subjects who received a dose of at least one product
|
0.00%
0/50 • Adverse events were collected for up to 2 months for each subject. The duration of the clinical phase of the study was 4 months.
All subjects who received a dose of at least one product
|
|
Investigations
Heart Rate increased
|
0.00%
0/49 • Adverse events were collected for up to 2 months for each subject. The duration of the clinical phase of the study was 4 months.
All subjects who received a dose of at least one product
|
0.00%
0/48 • Adverse events were collected for up to 2 months for each subject. The duration of the clinical phase of the study was 4 months.
All subjects who received a dose of at least one product
|
0.00%
0/47 • Adverse events were collected for up to 2 months for each subject. The duration of the clinical phase of the study was 4 months.
All subjects who received a dose of at least one product
|
0.00%
0/47 • Adverse events were collected for up to 2 months for each subject. The duration of the clinical phase of the study was 4 months.
All subjects who received a dose of at least one product
|
0.00%
0/48 • Adverse events were collected for up to 2 months for each subject. The duration of the clinical phase of the study was 4 months.
All subjects who received a dose of at least one product
|
2.0%
1/50 • Adverse events were collected for up to 2 months for each subject. The duration of the clinical phase of the study was 4 months.
All subjects who received a dose of at least one product
|
|
Cardiac disorders
Palpitations
|
0.00%
0/49 • Adverse events were collected for up to 2 months for each subject. The duration of the clinical phase of the study was 4 months.
All subjects who received a dose of at least one product
|
0.00%
0/48 • Adverse events were collected for up to 2 months for each subject. The duration of the clinical phase of the study was 4 months.
All subjects who received a dose of at least one product
|
2.1%
1/47 • Adverse events were collected for up to 2 months for each subject. The duration of the clinical phase of the study was 4 months.
All subjects who received a dose of at least one product
|
0.00%
0/47 • Adverse events were collected for up to 2 months for each subject. The duration of the clinical phase of the study was 4 months.
All subjects who received a dose of at least one product
|
0.00%
0/48 • Adverse events were collected for up to 2 months for each subject. The duration of the clinical phase of the study was 4 months.
All subjects who received a dose of at least one product
|
4.0%
2/50 • Adverse events were collected for up to 2 months for each subject. The duration of the clinical phase of the study was 4 months.
All subjects who received a dose of at least one product
|
|
Cardiac disorders
Sinus Tachycardia
|
0.00%
0/49 • Adverse events were collected for up to 2 months for each subject. The duration of the clinical phase of the study was 4 months.
All subjects who received a dose of at least one product
|
0.00%
0/48 • Adverse events were collected for up to 2 months for each subject. The duration of the clinical phase of the study was 4 months.
All subjects who received a dose of at least one product
|
0.00%
0/47 • Adverse events were collected for up to 2 months for each subject. The duration of the clinical phase of the study was 4 months.
All subjects who received a dose of at least one product
|
0.00%
0/47 • Adverse events were collected for up to 2 months for each subject. The duration of the clinical phase of the study was 4 months.
All subjects who received a dose of at least one product
|
2.1%
1/48 • Adverse events were collected for up to 2 months for each subject. The duration of the clinical phase of the study was 4 months.
All subjects who received a dose of at least one product
|
0.00%
0/50 • Adverse events were collected for up to 2 months for each subject. The duration of the clinical phase of the study was 4 months.
All subjects who received a dose of at least one product
|
|
Nervous system disorders
tremor
|
0.00%
0/49 • Adverse events were collected for up to 2 months for each subject. The duration of the clinical phase of the study was 4 months.
All subjects who received a dose of at least one product
|
0.00%
0/48 • Adverse events were collected for up to 2 months for each subject. The duration of the clinical phase of the study was 4 months.
All subjects who received a dose of at least one product
|
0.00%
0/47 • Adverse events were collected for up to 2 months for each subject. The duration of the clinical phase of the study was 4 months.
All subjects who received a dose of at least one product
|
0.00%
0/47 • Adverse events were collected for up to 2 months for each subject. The duration of the clinical phase of the study was 4 months.
All subjects who received a dose of at least one product
|
0.00%
0/48 • Adverse events were collected for up to 2 months for each subject. The duration of the clinical phase of the study was 4 months.
All subjects who received a dose of at least one product
|
4.0%
2/50 • Adverse events were collected for up to 2 months for each subject. The duration of the clinical phase of the study was 4 months.
All subjects who received a dose of at least one product
|
|
Nervous system disorders
Dizziness
|
0.00%
0/49 • Adverse events were collected for up to 2 months for each subject. The duration of the clinical phase of the study was 4 months.
All subjects who received a dose of at least one product
|
0.00%
0/48 • Adverse events were collected for up to 2 months for each subject. The duration of the clinical phase of the study was 4 months.
All subjects who received a dose of at least one product
|
8.5%
4/47 • Adverse events were collected for up to 2 months for each subject. The duration of the clinical phase of the study was 4 months.
All subjects who received a dose of at least one product
|
0.00%
0/47 • Adverse events were collected for up to 2 months for each subject. The duration of the clinical phase of the study was 4 months.
All subjects who received a dose of at least one product
|
0.00%
0/48 • Adverse events were collected for up to 2 months for each subject. The duration of the clinical phase of the study was 4 months.
All subjects who received a dose of at least one product
|
0.00%
0/50 • Adverse events were collected for up to 2 months for each subject. The duration of the clinical phase of the study was 4 months.
All subjects who received a dose of at least one product
|
|
Psychiatric disorders
Nervousness
|
0.00%
0/49 • Adverse events were collected for up to 2 months for each subject. The duration of the clinical phase of the study was 4 months.
All subjects who received a dose of at least one product
|
0.00%
0/48 • Adverse events were collected for up to 2 months for each subject. The duration of the clinical phase of the study was 4 months.
All subjects who received a dose of at least one product
|
2.1%
1/47 • Adverse events were collected for up to 2 months for each subject. The duration of the clinical phase of the study was 4 months.
All subjects who received a dose of at least one product
|
0.00%
0/47 • Adverse events were collected for up to 2 months for each subject. The duration of the clinical phase of the study was 4 months.
All subjects who received a dose of at least one product
|
2.1%
1/48 • Adverse events were collected for up to 2 months for each subject. The duration of the clinical phase of the study was 4 months.
All subjects who received a dose of at least one product
|
6.0%
3/50 • Adverse events were collected for up to 2 months for each subject. The duration of the clinical phase of the study was 4 months.
All subjects who received a dose of at least one product
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
0.00%
0/49 • Adverse events were collected for up to 2 months for each subject. The duration of the clinical phase of the study was 4 months.
All subjects who received a dose of at least one product
|
0.00%
0/48 • Adverse events were collected for up to 2 months for each subject. The duration of the clinical phase of the study was 4 months.
All subjects who received a dose of at least one product
|
0.00%
0/47 • Adverse events were collected for up to 2 months for each subject. The duration of the clinical phase of the study was 4 months.
All subjects who received a dose of at least one product
|
2.1%
1/47 • Adverse events were collected for up to 2 months for each subject. The duration of the clinical phase of the study was 4 months.
All subjects who received a dose of at least one product
|
0.00%
0/48 • Adverse events were collected for up to 2 months for each subject. The duration of the clinical phase of the study was 4 months.
All subjects who received a dose of at least one product
|
0.00%
0/50 • Adverse events were collected for up to 2 months for each subject. The duration of the clinical phase of the study was 4 months.
All subjects who received a dose of at least one product
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrtoea
|
0.00%
0/49 • Adverse events were collected for up to 2 months for each subject. The duration of the clinical phase of the study was 4 months.
All subjects who received a dose of at least one product
|
2.1%
1/48 • Adverse events were collected for up to 2 months for each subject. The duration of the clinical phase of the study was 4 months.
All subjects who received a dose of at least one product
|
0.00%
0/47 • Adverse events were collected for up to 2 months for each subject. The duration of the clinical phase of the study was 4 months.
All subjects who received a dose of at least one product
|
0.00%
0/47 • Adverse events were collected for up to 2 months for each subject. The duration of the clinical phase of the study was 4 months.
All subjects who received a dose of at least one product
|
0.00%
0/48 • Adverse events were collected for up to 2 months for each subject. The duration of the clinical phase of the study was 4 months.
All subjects who received a dose of at least one product
|
0.00%
0/50 • Adverse events were collected for up to 2 months for each subject. The duration of the clinical phase of the study was 4 months.
All subjects who received a dose of at least one product
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/49 • Adverse events were collected for up to 2 months for each subject. The duration of the clinical phase of the study was 4 months.
All subjects who received a dose of at least one product
|
0.00%
0/48 • Adverse events were collected for up to 2 months for each subject. The duration of the clinical phase of the study was 4 months.
All subjects who received a dose of at least one product
|
0.00%
0/47 • Adverse events were collected for up to 2 months for each subject. The duration of the clinical phase of the study was 4 months.
All subjects who received a dose of at least one product
|
2.1%
1/47 • Adverse events were collected for up to 2 months for each subject. The duration of the clinical phase of the study was 4 months.
All subjects who received a dose of at least one product
|
0.00%
0/48 • Adverse events were collected for up to 2 months for each subject. The duration of the clinical phase of the study was 4 months.
All subjects who received a dose of at least one product
|
2.0%
1/50 • Adverse events were collected for up to 2 months for each subject. The duration of the clinical phase of the study was 4 months.
All subjects who received a dose of at least one product
|
|
Vascular disorders
Flushing
|
0.00%
0/49 • Adverse events were collected for up to 2 months for each subject. The duration of the clinical phase of the study was 4 months.
All subjects who received a dose of at least one product
|
0.00%
0/48 • Adverse events were collected for up to 2 months for each subject. The duration of the clinical phase of the study was 4 months.
All subjects who received a dose of at least one product
|
0.00%
0/47 • Adverse events were collected for up to 2 months for each subject. The duration of the clinical phase of the study was 4 months.
All subjects who received a dose of at least one product
|
0.00%
0/47 • Adverse events were collected for up to 2 months for each subject. The duration of the clinical phase of the study was 4 months.
All subjects who received a dose of at least one product
|
0.00%
0/48 • Adverse events were collected for up to 2 months for each subject. The duration of the clinical phase of the study was 4 months.
All subjects who received a dose of at least one product
|
4.0%
2/50 • Adverse events were collected for up to 2 months for each subject. The duration of the clinical phase of the study was 4 months.
All subjects who received a dose of at least one product
|
|
Infections and infestations
URTI
|
0.00%
0/49 • Adverse events were collected for up to 2 months for each subject. The duration of the clinical phase of the study was 4 months.
All subjects who received a dose of at least one product
|
0.00%
0/48 • Adverse events were collected for up to 2 months for each subject. The duration of the clinical phase of the study was 4 months.
All subjects who received a dose of at least one product
|
0.00%
0/47 • Adverse events were collected for up to 2 months for each subject. The duration of the clinical phase of the study was 4 months.
All subjects who received a dose of at least one product
|
2.1%
1/47 • Adverse events were collected for up to 2 months for each subject. The duration of the clinical phase of the study was 4 months.
All subjects who received a dose of at least one product
|
0.00%
0/48 • Adverse events were collected for up to 2 months for each subject. The duration of the clinical phase of the study was 4 months.
All subjects who received a dose of at least one product
|
0.00%
0/50 • Adverse events were collected for up to 2 months for each subject. The duration of the clinical phase of the study was 4 months.
All subjects who received a dose of at least one product
|
|
Nervous system disorders
Paraesthesia Oral
|
0.00%
0/49 • Adverse events were collected for up to 2 months for each subject. The duration of the clinical phase of the study was 4 months.
All subjects who received a dose of at least one product
|
2.1%
1/48 • Adverse events were collected for up to 2 months for each subject. The duration of the clinical phase of the study was 4 months.
All subjects who received a dose of at least one product
|
0.00%
0/47 • Adverse events were collected for up to 2 months for each subject. The duration of the clinical phase of the study was 4 months.
All subjects who received a dose of at least one product
|
0.00%
0/47 • Adverse events were collected for up to 2 months for each subject. The duration of the clinical phase of the study was 4 months.
All subjects who received a dose of at least one product
|
0.00%
0/48 • Adverse events were collected for up to 2 months for each subject. The duration of the clinical phase of the study was 4 months.
All subjects who received a dose of at least one product
|
0.00%
0/50 • Adverse events were collected for up to 2 months for each subject. The duration of the clinical phase of the study was 4 months.
All subjects who received a dose of at least one product
|
|
Nervous system disorders
Presyncope
|
0.00%
0/49 • Adverse events were collected for up to 2 months for each subject. The duration of the clinical phase of the study was 4 months.
All subjects who received a dose of at least one product
|
2.1%
1/48 • Adverse events were collected for up to 2 months for each subject. The duration of the clinical phase of the study was 4 months.
All subjects who received a dose of at least one product
|
0.00%
0/47 • Adverse events were collected for up to 2 months for each subject. The duration of the clinical phase of the study was 4 months.
All subjects who received a dose of at least one product
|
0.00%
0/47 • Adverse events were collected for up to 2 months for each subject. The duration of the clinical phase of the study was 4 months.
All subjects who received a dose of at least one product
|
0.00%
0/48 • Adverse events were collected for up to 2 months for each subject. The duration of the clinical phase of the study was 4 months.
All subjects who received a dose of at least one product
|
0.00%
0/50 • Adverse events were collected for up to 2 months for each subject. The duration of the clinical phase of the study was 4 months.
All subjects who received a dose of at least one product
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The sponsor reserves the right to the first publication of the results. Following the first publication, or if the sponsor confirms in writing no interest in publishing the results, Quotient Clinical Ltd or the Principal Investigator may proceed to publish results from the study, giving the sponsor 60 days to review the manuscript.
- Publication restrictions are in place
Restriction type: OTHER