Trial Outcomes & Findings for Bioequivalence Study of Two Oral Haloperidol Tablets Formulations in Healthy Subjects Under Fed Conditions (NCT NCT04411953)
NCT ID: NCT04411953
Last Updated: 2022-06-08
Results Overview
The maximum observed concentration of haloperidol as measured by bioanalysis of the blood plasma is referred to as the Cmax.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
32 participants
Primary outcome timeframe
pre-dose (0 hours), and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 16, 24, 30, 36, 48, 72, 96, 120, 144, 168, 192 hours post dose
Results posted on
2022-06-08
Participant Flow
60 subjects participated in the screening phase of this study.
32 subjects were enrolled in the study. 24 subjects were excluded from the study. 3 subjects were placed on standby.
Participant milestones
| Measure |
Reference Product (Treatment A), Then Test Product (Treatment B)
Treatment A: Subjects received Haloperidol Tablets 2 mg Reference Product (Mylan Pharmaceuticals Inc.). Subjects also received as pre-medication Benztropine Mesylate Tablets, United States Pharmacopeia (USP) (1 mg every 10 to 12 hours), beginning 4 to 6 hours before dosing with Investigational Medicinal Product (IMP) and continued for a total of 4 doses.
A high-fat, high-calorie breakfast was served 30 minute before administration of the IMP.
Haloperidol Tablets, Mylan Pharmaceuticals Inc.: single dose, 2 mg Haloperidol tablet
Then
Treatment B:
|
Test Product (Treatment B), Then Reference Product (Treatment A)
Treatment B: Subjects received Haloperidol Tablets 2 mg Test Product (Cycle Pharmaceuticals Ltd). Subjects also received as pre-medication Benztropine Mesylate Tablets, USP (1 mg every 10 to 12 hours), beginning 4 to 6 hours before dosing with IMP and continued for a total of 4 doses.
A high-fat, high-calorie breakfast was served 30 minute before administration of the IMP.
Haloperidol Tablets, Cycle Pharmaceuticals Ltd: single dose, 2 mg Haloperidol tablet
Then
Treatment A: Subjects received Haloperidol Tablets 2 mg Reference Product (Mylan Pharmaceuticals Inc.). Subjects also received as pre-medication Benztropine Mesylate Tablets, USP (1 mg every 10 to 12 hours), beginning 4 to 6 hours before dosing with IMP and continued for a total of 4 doses.
A high-fat, high-calorie breakfast was served 30 minute before administration of the IMP.
|
|---|---|---|
|
Treatment Period 1 (8 Days)
STARTED
|
16
|
16
|
|
Treatment Period 1 (8 Days)
COMPLETED
|
16
|
16
|
|
Treatment Period 1 (8 Days)
NOT COMPLETED
|
0
|
0
|
|
Washout Period (14 Days)
STARTED
|
16
|
16
|
|
Washout Period (14 Days)
COMPLETED
|
16
|
15
|
|
Washout Period (14 Days)
NOT COMPLETED
|
0
|
1
|
|
Treatment Period 2 (8 Days)
STARTED
|
16
|
15
|
|
Treatment Period 2 (8 Days)
COMPLETED
|
16
|
15
|
|
Treatment Period 2 (8 Days)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Bioequivalence Study of Two Oral Haloperidol Tablets Formulations in Healthy Subjects Under Fed Conditions
Baseline characteristics by cohort
| Measure |
Sequence AB
n=16 Participants
Treatment A: Subjects received Haloperidol Tablets 2 mg Reference Product (Mylan Pharmaceuticals Inc.). Subjects also received as pre-medication Benztropine Mesylate Tablets, USP (1 mg every 10 to 12 hours), beginning 4 to 6 hours before dosing with IMP and continued for a total of 4 doses.
A high-fat, high-calorie breakfast was served 30 minute before administration of the IMP.
Haloperidol Tablets, Mylan Pharmaceuticals Inc.: single dose, 2 mg Haloperidol tablet
Treatment B: Subjects received Haloperidol Tablets 2 mg Test Product (Cycle Pharmaceuticals Ltd). Subjects also received as pre-medication Benztropine Mesylate Tablets, USP (1 mg every 10 to 12 hours), beginning 4 to 6 hours before dosing with IMP and continued for a total of 4 doses.
A high-fat, high-calorie breakfast was served 30 minute before administration of the IMP.
Haloperidol Tablets, Cycle Pharmaceuticals Ltd: single dose, 2 mg Haloperidol tablet
|
Sequence BA
n=16 Participants
Treatment B: Subjects received Haloperidol Tablets 2 mg Test Product (Cycle Pharmaceuticals Ltd). Subjects also received as pre-medication Benztropine Mesylate Tablets, USP (1 mg every 10 to 12 hours), beginning 4 to 6 hours before dosing with IMP and continued for a total of 4 doses.
A high-fat, high-calorie breakfast was served 30 minute before administration of the IMP.
Haloperidol Tablets, Cycle Pharmaceuticals Ltd: single dose, 2 mg Haloperidol tablet
Treatment A: Subjects received Haloperidol Tablets 2 mg Reference Product (Mylan Pharmaceuticals Inc.). Subjects also received as pre-medication Benztropine Mesylate Tablets, USP (1 mg every 10 to 12 hours), beginning 4 to 6 hours before dosing with IMP and continued for a total of 4 doses.
A high-fat, high-calorie breakfast was served 30 minute before administration of the IMP.
Haloperidol Tablets, Mylan Pharmaceuticals Inc.: single dose, 2 mg Haloperidol tablet
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
28.3 Years
STANDARD_DEVIATION 9.64 • n=93 Participants
|
26.2 Years
STANDARD_DEVIATION 6.30 • n=4 Participants
|
27.3 Years
STANDARD_DEVIATION 8.08 • n=27 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=93 Participants
|
15 Participants
n=4 Participants
|
27 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
14 Participants
n=93 Participants
|
14 Participants
n=4 Participants
|
28 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Region of Enrollment
South Africa
|
16 participants
n=93 Participants
|
16 participants
n=4 Participants
|
32 participants
n=27 Participants
|
|
Height
|
170.53 cm
STANDARD_DEVIATION 8.586 • n=93 Participants
|
168.64 cm
STANDARD_DEVIATION 8.380 • n=4 Participants
|
169.59 cm
STANDARD_DEVIATION 8.401 • n=27 Participants
|
|
Weight
|
69.69 kg
STANDARD_DEVIATION 12.121 • n=93 Participants
|
65.63 kg
STANDARD_DEVIATION 10.036 • n=4 Participants
|
67.66 kg
STANDARD_DEVIATION 11.139 • n=27 Participants
|
|
BMI
|
23.90 kg/m^2
STANDARD_DEVIATION 3.300 • n=93 Participants
|
23.03 kg/m^2
STANDARD_DEVIATION 2.763 • n=4 Participants
|
23.47 kg/m^2
STANDARD_DEVIATION 3.026 • n=27 Participants
|
PRIMARY outcome
Timeframe: pre-dose (0 hours), and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 16, 24, 30, 36, 48, 72, 96, 120, 144, 168, 192 hours post dosePopulation: One subject was withdrawn after the interim safety analysis during the washout period and so did not complete Treatment Period 2 (the subject was scheduled to receive Test Product (Treatment B)). Since only 31 subjects completed the study, only 31 subjects were included in the statistical analysis.
The maximum observed concentration of haloperidol as measured by bioanalysis of the blood plasma is referred to as the Cmax.
Outcome measures
| Measure |
Reference Product (Treatment A)
n=31 Participants
Subjects received Haloperidol Tablets 2 mg Reference Product (Mylan Pharmaceuticals Inc.). Subjects also received as pre-medication Benztropine Mesylate Tablets, USP (1 mg every 10 to 12 hours), beginning 4 to 6 hours before dosing with IMP and continued for a total of 4 doses.
A high-fat, high-calorie breakfast was served 30 minute before administration of the IMP.
Haloperidol Tablets, Mylan Pharmaceuticals Inc.: single dose, 2 mg Haloperidol tablet
|
Test Product (Treatment B)
n=31 Participants
Subjects received Haloperidol Tablets 2 mg Test Product (Cycle Pharmaceuticals Ltd). Subjects also received as pre-medication Benztropine Mesylate Tablets, USP (1 mg every 10 to 12 hours), beginning 4 to 6 hours before dosing with IMP and continued for a total of 4 doses.
A high-fat, high-calorie breakfast was served 30 minute before administration of the IMP.
Haloperidol Tablets, Cycle Pharmaceuticals Ltd: single dose, 2 mg Haloperidol tablet
|
|---|---|---|
|
Concentration Maximum (Cmax)
|
1.326 ng/ml
Standard Deviation 0.4338
|
1.293 ng/ml
Standard Deviation 0.3919
|
PRIMARY outcome
Timeframe: pre-dose (0 hours), and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 16, 24, 30, 36, 48, 72, 96, 120, 144, 168, 192 hours post dosePopulation: One subject was withdrawn after the interim safety analysis during the washout period and so did not complete Treatment Period 2 (the subject was scheduled to receive Test Product (Treatment B)). Since only 31 subjects completed the study, only 31 subjects were included in the statistical analysis.
Area under the plasma concentration versus time curve from time zero to t, where t is the time of the timepoint of the last quantifiable concentration of haloperidol in the blood plasma. The curve is constructed by plotting the concentration of haloperidol in the blood plasma against the time for each blood sample.
Outcome measures
| Measure |
Reference Product (Treatment A)
n=31 Participants
Subjects received Haloperidol Tablets 2 mg Reference Product (Mylan Pharmaceuticals Inc.). Subjects also received as pre-medication Benztropine Mesylate Tablets, USP (1 mg every 10 to 12 hours), beginning 4 to 6 hours before dosing with IMP and continued for a total of 4 doses.
A high-fat, high-calorie breakfast was served 30 minute before administration of the IMP.
Haloperidol Tablets, Mylan Pharmaceuticals Inc.: single dose, 2 mg Haloperidol tablet
|
Test Product (Treatment B)
n=31 Participants
Subjects received Haloperidol Tablets 2 mg Test Product (Cycle Pharmaceuticals Ltd). Subjects also received as pre-medication Benztropine Mesylate Tablets, USP (1 mg every 10 to 12 hours), beginning 4 to 6 hours before dosing with IMP and continued for a total of 4 doses.
A high-fat, high-calorie breakfast was served 30 minute before administration of the IMP.
Haloperidol Tablets, Cycle Pharmaceuticals Ltd: single dose, 2 mg Haloperidol tablet
|
|---|---|---|
|
Area Under the Curve (0-t) (AUC(0-t))
|
27.75 h*ng/ml
Standard Deviation 10.19
|
28.46 h*ng/ml
Standard Deviation 11.78
|
PRIMARY outcome
Timeframe: pre-dose (0 hours), and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 16, 24, 30, 36, 48, 72, 96, 120, 144, 168, 192 hours post dosePopulation: One subject was withdrawn after the interim safety analysis during the washout period and so did not complete Treatment Period 2 (the subject was scheduled to receive Test Product (Treatment B)). Since only 31 subjects completed the study, only 31 subjects were included in the statistical analysis.
Area under the plasma concentration versus time curve from time zero to ∞, where ∞ is the timepoint of the last quantifiable concentration of haloperidol in the blood plasma, plus it's elimination rate constant. AUC(0-∞) = AUC(0-t) + AUC(t-∞).
Outcome measures
| Measure |
Reference Product (Treatment A)
n=31 Participants
Subjects received Haloperidol Tablets 2 mg Reference Product (Mylan Pharmaceuticals Inc.). Subjects also received as pre-medication Benztropine Mesylate Tablets, USP (1 mg every 10 to 12 hours), beginning 4 to 6 hours before dosing with IMP and continued for a total of 4 doses.
A high-fat, high-calorie breakfast was served 30 minute before administration of the IMP.
Haloperidol Tablets, Mylan Pharmaceuticals Inc.: single dose, 2 mg Haloperidol tablet
|
Test Product (Treatment B)
n=31 Participants
Subjects received Haloperidol Tablets 2 mg Test Product (Cycle Pharmaceuticals Ltd). Subjects also received as pre-medication Benztropine Mesylate Tablets, USP (1 mg every 10 to 12 hours), beginning 4 to 6 hours before dosing with IMP and continued for a total of 4 doses.
A high-fat, high-calorie breakfast was served 30 minute before administration of the IMP.
Haloperidol Tablets, Cycle Pharmaceuticals Ltd: single dose, 2 mg Haloperidol tablet
|
|---|---|---|
|
Area Under the Curve(0-∞) (AUC(0-∞))
|
30.61 h*ng/ml
Standard Deviation 11.29
|
31.34 h*ng/ml
Standard Deviation 12.06
|
SECONDARY outcome
Timeframe: pre-dose (0 hours), and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 16, 24, 30, 36, 48, 72, 96, 120, 144, 168, 192 hours post dosePopulation: One subject was withdrawn after the interim safety analysis during the washout period and so did not complete Treatment Period 2 (the subject was scheduled to receive Test Product (Treatment B)). Since only 31 subjects completed the study, only 31 subjects were included in the statistical analysis.
The timepoint at which the maximum concentration of haloperidol as measured by bioanalysis of the blood plasma is observed.
Outcome measures
| Measure |
Reference Product (Treatment A)
n=31 Participants
Subjects received Haloperidol Tablets 2 mg Reference Product (Mylan Pharmaceuticals Inc.). Subjects also received as pre-medication Benztropine Mesylate Tablets, USP (1 mg every 10 to 12 hours), beginning 4 to 6 hours before dosing with IMP and continued for a total of 4 doses.
A high-fat, high-calorie breakfast was served 30 minute before administration of the IMP.
Haloperidol Tablets, Mylan Pharmaceuticals Inc.: single dose, 2 mg Haloperidol tablet
|
Test Product (Treatment B)
n=31 Participants
Subjects received Haloperidol Tablets 2 mg Test Product (Cycle Pharmaceuticals Ltd). Subjects also received as pre-medication Benztropine Mesylate Tablets, USP (1 mg every 10 to 12 hours), beginning 4 to 6 hours before dosing with IMP and continued for a total of 4 doses.
A high-fat, high-calorie breakfast was served 30 minute before administration of the IMP.
Haloperidol Tablets, Cycle Pharmaceuticals Ltd: single dose, 2 mg Haloperidol tablet
|
|---|---|---|
|
Time to Maximum Concentration (Tmax)
|
4.871 Hours
Standard Deviation 3.750
|
3.839 Hours
Standard Deviation 1.274
|
SECONDARY outcome
Timeframe: pre-dose (0 hours), and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 16, 24, 30, 36, 48, 72, 96, 120, 144, 168, 192 hours post dosePopulation: One subject was withdrawn after the interim safety analysis during the washout period and so did not complete Treatment Period 2 (the subject was scheduled to receive Test Product (Treatment B)). Since only 31 subjects completed the study, only 31 subjects were included in the statistical analysis.
Terminal elimination rate constant (λz) is a mathematical estimate calculated using log-linear regression of the terminal portions of a blood plasma concentration against time curve.
Outcome measures
| Measure |
Reference Product (Treatment A)
n=31 Participants
Subjects received Haloperidol Tablets 2 mg Reference Product (Mylan Pharmaceuticals Inc.). Subjects also received as pre-medication Benztropine Mesylate Tablets, USP (1 mg every 10 to 12 hours), beginning 4 to 6 hours before dosing with IMP and continued for a total of 4 doses.
A high-fat, high-calorie breakfast was served 30 minute before administration of the IMP.
Haloperidol Tablets, Mylan Pharmaceuticals Inc.: single dose, 2 mg Haloperidol tablet
|
Test Product (Treatment B)
n=31 Participants
Subjects received Haloperidol Tablets 2 mg Test Product (Cycle Pharmaceuticals Ltd). Subjects also received as pre-medication Benztropine Mesylate Tablets, USP (1 mg every 10 to 12 hours), beginning 4 to 6 hours before dosing with IMP and continued for a total of 4 doses.
A high-fat, high-calorie breakfast was served 30 minute before administration of the IMP.
Haloperidol Tablets, Cycle Pharmaceuticals Ltd: single dose, 2 mg Haloperidol tablet
|
|---|---|---|
|
Terminal Elimination Rate Constant (λz)
|
0.01114 1/h
Standard Deviation 0.003451
|
0.01152 1/h
Standard Deviation 0.004028
|
SECONDARY outcome
Timeframe: pre-dose (0 hours), and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 16, 24, 30, 36, 48, 72, 96, 120, 144, 168, 192 hours post dosePopulation: One subject was withdrawn after the interim safety analysis during the washout period and so did not complete Treatment Period 2 (the subject was scheduled to receive Test Product (Treatment B)). Since only 31 subjects completed the study, only 31 subjects were included in the statistical analysis.
The apparent terminal elimination half-life (t½) is defined as the time necessary for the concentration of a drug to decrease by one-half in the terminal phase.
Outcome measures
| Measure |
Reference Product (Treatment A)
n=31 Participants
Subjects received Haloperidol Tablets 2 mg Reference Product (Mylan Pharmaceuticals Inc.). Subjects also received as pre-medication Benztropine Mesylate Tablets, USP (1 mg every 10 to 12 hours), beginning 4 to 6 hours before dosing with IMP and continued for a total of 4 doses.
A high-fat, high-calorie breakfast was served 30 minute before administration of the IMP.
Haloperidol Tablets, Mylan Pharmaceuticals Inc.: single dose, 2 mg Haloperidol tablet
|
Test Product (Treatment B)
n=31 Participants
Subjects received Haloperidol Tablets 2 mg Test Product (Cycle Pharmaceuticals Ltd). Subjects also received as pre-medication Benztropine Mesylate Tablets, USP (1 mg every 10 to 12 hours), beginning 4 to 6 hours before dosing with IMP and continued for a total of 4 doses.
A high-fat, high-calorie breakfast was served 30 minute before administration of the IMP.
Haloperidol Tablets, Cycle Pharmaceuticals Ltd: single dose, 2 mg Haloperidol tablet
|
|---|---|---|
|
Terminal Elimination Half-life (t½)
|
69.12 Hours
Standard Deviation 26.40
|
70.19 Hours
Standard Deviation 35.25
|
Adverse Events
Reference Product (Treatment A)
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
Test Product (Treatment B)
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Reference Product (Treatment A)
n=31 participants at risk
Subjects received Haloperidol Tablets 2 mg Reference Product (Mylan Pharmaceuticals Inc.). Subjects also received as pre-medication Benztropine Mesylate Tablets, USP (1 mg every 10 to 12 hours), beginning 4 to 6 hours before dosing with IMP and continued for a total of 4 doses.
A high-fat, high-calorie breakfast was served 30 minute before administration of the IMP.
Haloperidol Tablets, Mylan Pharmaceuticals Inc.: single dose, 2 mg Haloperidol tablet
|
Test Product (Treatment B)
n=32 participants at risk
Subjects received Haloperidol Tablets 2 mg Test Product (Cycle Pharmaceuticals Ltd). Subjects also received as pre-medication Benztropine Mesylate Tablets, USP (1 mg every 10 to 12 hours), beginning 4 to 6 hours before dosing with IMP and continued for a total of 4 doses.
A high-fat, high-calorie breakfast was served 30 minute before administration of the IMP.
Haloperidol Tablets, Cycle Pharmaceuticals Ltd: single dose, 2 mg Haloperidol tablet
|
|---|---|---|
|
Gastrointestinal disorders
Dry Mouth
|
19.4%
6/31 • Number of events 7 • Adverse events data was collected for the duration of the study (24 days).
|
21.9%
7/32 • Number of events 8 • Adverse events data was collected for the duration of the study (24 days).
|
|
Gastrointestinal disorders
Constipation
|
3.2%
1/31 • Number of events 1 • Adverse events data was collected for the duration of the study (24 days).
|
6.2%
2/32 • Number of events 2 • Adverse events data was collected for the duration of the study (24 days).
|
|
Gastrointestinal disorders
Abdominal Discomfort
|
3.2%
1/31 • Number of events 1 • Adverse events data was collected for the duration of the study (24 days).
|
3.1%
1/32 • Number of events 1 • Adverse events data was collected for the duration of the study (24 days).
|
|
Gastrointestinal disorders
Abdominal Distension
|
0.00%
0/31 • Adverse events data was collected for the duration of the study (24 days).
|
3.1%
1/32 • Number of events 1 • Adverse events data was collected for the duration of the study (24 days).
|
|
Gastrointestinal disorders
Aphthous Ulcer
|
3.2%
1/31 • Number of events 1 • Adverse events data was collected for the duration of the study (24 days).
|
0.00%
0/32 • Adverse events data was collected for the duration of the study (24 days).
|
|
Gastrointestinal disorders
Diarrhoea
|
3.2%
1/31 • Number of events 1 • Adverse events data was collected for the duration of the study (24 days).
|
0.00%
0/32 • Adverse events data was collected for the duration of the study (24 days).
|
|
Gastrointestinal disorders
Haemorrhoids
|
3.2%
1/31 • Number of events 1 • Adverse events data was collected for the duration of the study (24 days).
|
0.00%
0/32 • Adverse events data was collected for the duration of the study (24 days).
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/31 • Adverse events data was collected for the duration of the study (24 days).
|
3.1%
1/32 • Number of events 1 • Adverse events data was collected for the duration of the study (24 days).
|
|
Respiratory, thoracic and mediastinal disorders
Dry Throat
|
22.6%
7/31 • Number of events 7 • Adverse events data was collected for the duration of the study (24 days).
|
18.8%
6/32 • Number of events 6 • Adverse events data was collected for the duration of the study (24 days).
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
6.5%
2/31 • Number of events 3 • Adverse events data was collected for the duration of the study (24 days).
|
6.2%
2/32 • Number of events 3 • Adverse events data was collected for the duration of the study (24 days).
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
3.2%
1/31 • Number of events 1 • Adverse events data was collected for the duration of the study (24 days).
|
0.00%
0/32 • Adverse events data was collected for the duration of the study (24 days).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Dryness
|
3.2%
1/31 • Number of events 1 • Adverse events data was collected for the duration of the study (24 days).
|
0.00%
0/32 • Adverse events data was collected for the duration of the study (24 days).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
3.2%
1/31 • Number of events 1 • Adverse events data was collected for the duration of the study (24 days).
|
0.00%
0/32 • Adverse events data was collected for the duration of the study (24 days).
|
|
Respiratory, thoracic and mediastinal disorders
Throat Irritation
|
0.00%
0/31 • Adverse events data was collected for the duration of the study (24 days).
|
3.1%
1/32 • Number of events 1 • Adverse events data was collected for the duration of the study (24 days).
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway Cough Syndrome
|
0.00%
0/31 • Adverse events data was collected for the duration of the study (24 days).
|
3.1%
1/32 • Number of events 1 • Adverse events data was collected for the duration of the study (24 days).
|
|
Nervous system disorders
Dizziness
|
9.7%
3/31 • Number of events 4 • Adverse events data was collected for the duration of the study (24 days).
|
15.6%
5/32 • Number of events 5 • Adverse events data was collected for the duration of the study (24 days).
|
|
Nervous system disorders
Headache
|
12.9%
4/31 • Number of events 6 • Adverse events data was collected for the duration of the study (24 days).
|
6.2%
2/32 • Number of events 2 • Adverse events data was collected for the duration of the study (24 days).
|
|
Eye disorders
Vision Blurred
|
12.9%
4/31 • Number of events 4 • Adverse events data was collected for the duration of the study (24 days).
|
15.6%
5/32 • Number of events 5 • Adverse events data was collected for the duration of the study (24 days).
|
|
Eye disorders
Eye Pruritus
|
3.2%
1/31 • Number of events 1 • Adverse events data was collected for the duration of the study (24 days).
|
0.00%
0/32 • Adverse events data was collected for the duration of the study (24 days).
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
3.2%
1/31 • Number of events 1 • Adverse events data was collected for the duration of the study (24 days).
|
3.1%
1/32 • Number of events 1 • Adverse events data was collected for the duration of the study (24 days).
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
0.00%
0/31 • Adverse events data was collected for the duration of the study (24 days).
|
6.2%
2/32 • Number of events 2 • Adverse events data was collected for the duration of the study (24 days).
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
3.2%
1/31 • Number of events 1 • Adverse events data was collected for the duration of the study (24 days).
|
0.00%
0/32 • Adverse events data was collected for the duration of the study (24 days).
|
|
Musculoskeletal and connective tissue disorders
Spinal Pain
|
0.00%
0/31 • Adverse events data was collected for the duration of the study (24 days).
|
3.1%
1/32 • Number of events 1 • Adverse events data was collected for the duration of the study (24 days).
|
|
Skin and subcutaneous tissue disorders
Rash
|
9.7%
3/31 • Number of events 3 • Adverse events data was collected for the duration of the study (24 days).
|
3.1%
1/32 • Number of events 1 • Adverse events data was collected for the duration of the study (24 days).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
3.2%
1/31 • Number of events 1 • Adverse events data was collected for the duration of the study (24 days).
|
0.00%
0/32 • Adverse events data was collected for the duration of the study (24 days).
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
6.5%
2/31 • Number of events 2 • Adverse events data was collected for the duration of the study (24 days).
|
3.1%
1/32 • Number of events 1 • Adverse events data was collected for the duration of the study (24 days).
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/31 • Adverse events data was collected for the duration of the study (24 days).
|
3.1%
1/32 • Number of events 1 • Adverse events data was collected for the duration of the study (24 days).
|
|
Infections and infestations
Respiratory Tract Infection
|
0.00%
0/31 • Adverse events data was collected for the duration of the study (24 days).
|
3.1%
1/32 • Number of events 1 • Adverse events data was collected for the duration of the study (24 days).
|
|
General disorders
Non-cardiac Chest Pain
|
3.2%
1/31 • Number of events 1 • Adverse events data was collected for the duration of the study (24 days).
|
0.00%
0/32 • Adverse events data was collected for the duration of the study (24 days).
|
|
Injury, poisoning and procedural complications
Skin Laceration
|
3.2%
1/31 • Number of events 1 • Adverse events data was collected for the duration of the study (24 days).
|
0.00%
0/32 • Adverse events data was collected for the duration of the study (24 days).
|
|
Investigations
Alanine Aminotransferase Increased
|
0.00%
0/31 • Adverse events data was collected for the duration of the study (24 days).
|
3.1%
1/32 • Number of events 1 • Adverse events data was collected for the duration of the study (24 days).
|
|
Investigations
Aspartate Aminotransferase Increased
|
0.00%
0/31 • Adverse events data was collected for the duration of the study (24 days).
|
3.1%
1/32 • Number of events 1 • Adverse events data was collected for the duration of the study (24 days).
|
|
Psychiatric disorders
Hypervigilance
|
0.00%
0/31 • Adverse events data was collected for the duration of the study (24 days).
|
3.1%
1/32 • Number of events 1 • Adverse events data was collected for the duration of the study (24 days).
|
Additional Information
Head of Global Regulatory Affairs and Clinical Development
Cycle Pharmaceuticals
Phone: +441223803635
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place