Trial Outcomes & Findings for Comparison of Deferiprone Extended Release Tablets and Ferriprox Immediate Release Tablets in Healthy Volunteers (NCT NCT02465489)
NCT ID: NCT02465489
Last Updated: 2016-02-26
Results Overview
Maximum measured serum concentration. Blood samples will be collected pre-dose and over a 24-hour interval post-dose
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
20 participants
Primary outcome timeframe
Samples were collected pre-dose and at 0.25, 0.5, 0.75, 1.0, 1.33, 1.66, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 8.0, 12.0, 16.0, and 24.0 hours post-dose.
Results posted on
2016-02-26
Participant Flow
Participant milestones
| Measure |
Healthy Volunteers
Subjects were randomized to receive the following five treatments in different orders, with a 7-day washout period between treatments::
A: Deferiprone ER tablets under fasting conditions B: Deferiprone ER tablets under fed conditions C: Deferiprone ER tablets administered as half-tablets under fed conditions D: Ferriprox IR tablets under fasting conditions E: Ferriprox IR tablets under fed conditions
The sequences were as follows;
* Sequence 1 (n=4): A-B-E-C-D
* Sequence 2 (n=4): B-C-A-D-E
* Sequence 3 (n=4): C-D-B-E-A
* Sequence 4 (n=4): D-E-C-A-B
* Sequence 5 (n=4): E-A-D-B-C
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
15
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
| Measure |
Healthy Volunteers
Subjects were randomized to receive the following five treatments in different orders, with a 7-day washout period between treatments::
A: Deferiprone ER tablets under fasting conditions B: Deferiprone ER tablets under fed conditions C: Deferiprone ER tablets administered as half-tablets under fed conditions D: Ferriprox IR tablets under fasting conditions E: Ferriprox IR tablets under fed conditions
The sequences were as follows;
* Sequence 1 (n=4): A-B-E-C-D
* Sequence 2 (n=4): B-C-A-D-E
* Sequence 3 (n=4): C-D-B-E-A
* Sequence 4 (n=4): D-E-C-A-B
* Sequence 5 (n=4): E-A-D-B-C
|
|---|---|
|
Overall Study
Adverse Event
|
5
|
Baseline Characteristics
Comparison of Deferiprone Extended Release Tablets and Ferriprox Immediate Release Tablets in Healthy Volunteers
Baseline characteristics by cohort
| Measure |
Healthy Volunteers
n=20 Participants
Subjects were randomized to receive five treatments in different orders:
* deferiprone ER tablets under fasting conditions
* deferiprone ER tablets under fed conditions
* deferiprone ER tablets administered as half-tablets under fed conditions
* Ferriprox IR tablets under fasting conditions
* Ferriprox IR tablets under fed conditions
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
20 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Samples were collected pre-dose and at 0.25, 0.5, 0.75, 1.0, 1.33, 1.66, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 8.0, 12.0, 16.0, and 24.0 hours post-dose.Population: The pharmacokinetic population included subjects who provided evaluable data for at least two study periods.
Maximum measured serum concentration. Blood samples will be collected pre-dose and over a 24-hour interval post-dose
Outcome measures
| Measure |
Extended Release, Fasting Conditions
n=16 Participants
A single 1000 mg dose of deferiprone extended release tablet formulation administered following a 10-hour fast
Deferiprone extended release: Deferiprone 1000 mg extended release tablet formulation
|
Extended Release, Fed Conditions
n=16 Participants
A single 1000 mg dose of deferiprone extended release tablet formulation administered following a high-fat breakfast
Deferiprone extended release: Deferiprone 1000 mg extended release tablet formulation
|
Extended Release Half-tablets, Fed Conditions
n=14 Participants
A single 1000 mg dose of deferiprone extended release tablet formulation (one 1000 mg tablet divided in two) administered following a high-fat breakfast
Deferiprone extended release: Deferiprone 1000 mg extended release tablet formulation
|
Immediate Release, Fasting Conditions
n=16 Participants
A single 1000 mg dose of Ferriprox immediate release tablet formulation administered following a 10-hour fast
Deferiprone immediate release: Ferriprox (deferiprone) 500 mg immediate release tablet formulation
|
Immediate Release, Fed Conditions
n=15 Participants
A single 1000 mg dose of Ferriprox immediate release tablet formulation administered following a high-fat breakfast
Deferiprone immediate release: Ferriprox (deferiprone) 500 mg immediate release tablet formulation
|
|---|---|---|---|---|---|
|
Cmax for Serum Deferiprone
|
3.89 μg/mL
Standard Deviation 1.47
|
2.76 μg/mL
Standard Deviation 1.45
|
3.02 μg/mL
Standard Deviation 1.03
|
13.89 μg/mL
Standard Deviation 3.84
|
9.77 μg/mL
Standard Deviation 3.60
|
PRIMARY outcome
Timeframe: Samples were collected pre-dose and at 0.25, 0.5, 0.75, 1.0, 1.33, 1.66, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 8.0, 12.0, 16.0, and 24.0 hours post-dose.Population: The pharmacokinetic population included subjects who provided evaluable data for at least two study periods
Time of maximum observed serum concentration. Blood samples will be collected pre-dose and over a 24-hour interval post-dose
Outcome measures
| Measure |
Extended Release, Fasting Conditions
n=16 Participants
A single 1000 mg dose of deferiprone extended release tablet formulation administered following a 10-hour fast
Deferiprone extended release: Deferiprone 1000 mg extended release tablet formulation
|
Extended Release, Fed Conditions
n=16 Participants
A single 1000 mg dose of deferiprone extended release tablet formulation administered following a high-fat breakfast
Deferiprone extended release: Deferiprone 1000 mg extended release tablet formulation
|
Extended Release Half-tablets, Fed Conditions
n=14 Participants
A single 1000 mg dose of deferiprone extended release tablet formulation (one 1000 mg tablet divided in two) administered following a high-fat breakfast
Deferiprone extended release: Deferiprone 1000 mg extended release tablet formulation
|
Immediate Release, Fasting Conditions
n=16 Participants
A single 1000 mg dose of Ferriprox immediate release tablet formulation administered following a 10-hour fast
Deferiprone immediate release: Ferriprox (deferiprone) 500 mg immediate release tablet formulation
|
Immediate Release, Fed Conditions
n=15 Participants
A single 1000 mg dose of Ferriprox immediate release tablet formulation administered following a high-fat breakfast
Deferiprone immediate release: Ferriprox (deferiprone) 500 mg immediate release tablet formulation
|
|---|---|---|---|---|---|
|
Tmax for Serum Deferiprone
|
3.63 Hour
Standard Deviation 1.10
|
15.66 Hour
Standard Deviation 9.33
|
8.29 Hour
Standard Deviation 7.25
|
0.94 Hour
Standard Deviation 0.63
|
1.91 Hour
Standard Deviation 0.95
|
PRIMARY outcome
Timeframe: Samples were collected pre-dose and at 0.25, 0.5, 0.75, 1.0, 1.33, 1.66, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 8.0, 12.0, 16.0, and 24.0 hours post-dose.Population: The pharmacokinetic population included subjects who provided evaluable data for at least two study periods
Area under the serum concentration time curve extrapolated to infinity. Blood samples will be collected pre-dose and over a 24-hour interval post-dose.
Outcome measures
| Measure |
Extended Release, Fasting Conditions
n=15 Participants
A single 1000 mg dose of deferiprone extended release tablet formulation administered following a 10-hour fast
Deferiprone extended release: Deferiprone 1000 mg extended release tablet formulation
|
Extended Release, Fed Conditions
n=2 Participants
A single 1000 mg dose of deferiprone extended release tablet formulation administered following a high-fat breakfast
Deferiprone extended release: Deferiprone 1000 mg extended release tablet formulation
|
Extended Release Half-tablets, Fed Conditions
n=5 Participants
A single 1000 mg dose of deferiprone extended release tablet formulation (one 1000 mg tablet divided in two) administered following a high-fat breakfast
Deferiprone extended release: Deferiprone 1000 mg extended release tablet formulation
|
Immediate Release, Fasting Conditions
n=16 Participants
A single 1000 mg dose of Ferriprox immediate release tablet formulation administered following a 10-hour fast
Deferiprone immediate release: Ferriprox (deferiprone) 500 mg immediate release tablet formulation
|
Immediate Release, Fed Conditions
n=15 Participants
A single 1000 mg dose of Ferriprox immediate release tablet formulation administered following a high-fat breakfast
Deferiprone immediate release: Ferriprox (deferiprone) 500 mg immediate release tablet formulation
|
|---|---|---|---|---|---|
|
AUC0-∞for Serum Deferiprone
|
31.42 ug*h/mL
Standard Deviation 6.68
|
40.52 ug*h/mL
Standard Deviation 0.77
|
31.72 ug*h/mL
Standard Deviation 8.21
|
34.81 ug*h/mL
Standard Deviation 6.81
|
33.02 ug*h/mL
Standard Deviation 7.19
|
SECONDARY outcome
Timeframe: Throughout the trial, from the time of the first dose until the last study visit (Day 36 or early termination)Population: The safety population included all subjects who received at least one of the investigational products under study
Number of subjects with AEs. AEs will include clinically significant changes from baseline in vital signs, 12-lead ECG, physical examinations, and laboratory tests.
Outcome measures
| Measure |
Extended Release, Fasting Conditions
n=18 Participants
A single 1000 mg dose of deferiprone extended release tablet formulation administered following a 10-hour fast
Deferiprone extended release: Deferiprone 1000 mg extended release tablet formulation
|
Extended Release, Fed Conditions
n=16 Participants
A single 1000 mg dose of deferiprone extended release tablet formulation administered following a high-fat breakfast
Deferiprone extended release: Deferiprone 1000 mg extended release tablet formulation
|
Extended Release Half-tablets, Fed Conditions
n=16 Participants
A single 1000 mg dose of deferiprone extended release tablet formulation (one 1000 mg tablet divided in two) administered following a high-fat breakfast
Deferiprone extended release: Deferiprone 1000 mg extended release tablet formulation
|
Immediate Release, Fasting Conditions
n=16 Participants
A single 1000 mg dose of Ferriprox immediate release tablet formulation administered following a 10-hour fast
Deferiprone immediate release: Ferriprox (deferiprone) 500 mg immediate release tablet formulation
|
Immediate Release, Fed Conditions
n=16 Participants
A single 1000 mg dose of Ferriprox immediate release tablet formulation administered following a high-fat breakfast
Deferiprone immediate release: Ferriprox (deferiprone) 500 mg immediate release tablet formulation
|
|---|---|---|---|---|---|
|
Number of Subjects With Adverse Events (AEs)
|
5 participants
|
2 participants
|
3 participants
|
1 participants
|
3 participants
|
Adverse Events
Extended Release, Fasting Conditions
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Extended Release, Fed Conditions
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Extended Release Half-tablets, Fed Conditions
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Immediate Release, Fasting Conditions
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Immediate Release, Fed Conditions
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Extended Release, Fasting Conditions
n=18 participants at risk
A single 1000 mg dose of deferiprone extended release tablet formulation administered following a 10-hour fast
Deferiprone extended release: Deferiprone 1000 mg extended release tablet formulation
|
Extended Release, Fed Conditions
n=16 participants at risk
A single 1000 mg dose of deferiprone extended release tablet formulation administered following a high-fat breakfast
Deferiprone extended release: Deferiprone 1000 mg extended release tablet formulation
|
Extended Release Half-tablets, Fed Conditions
n=16 participants at risk
A single 1000 mg dose of deferiprone extended release tablet formulation (one 1000 mg tablet divided in two) administered following a high-fat breakfast
Deferiprone extended release: Deferiprone 1000 mg extended release tablet formulation
|
Immediate Release, Fasting Conditions
n=16 participants at risk
A single 1000 mg dose of Ferriprox immediate release tablet formulation administered following a 10-hour fast
Deferiprone immediate release: Ferriprox (deferiprone) 500 mg immediate release tablet formulation
|
Immediate Release, Fed Conditions
n=16 participants at risk
A single 1000 mg dose of Ferriprox immediate release tablet formulation administered following a high-fat breakfast
Deferiprone immediate release: Ferriprox (deferiprone) 500 mg immediate release tablet formulation
|
|---|---|---|---|---|---|
|
Investigations
Amylase Increased
|
0.00%
0/18 • Adverse events were collected from the administration of the first dose in period 1 until the end-of-study visit
|
0.00%
0/16 • Adverse events were collected from the administration of the first dose in period 1 until the end-of-study visit
|
6.2%
1/16 • Number of events 1 • Adverse events were collected from the administration of the first dose in period 1 until the end-of-study visit
|
0.00%
0/16 • Adverse events were collected from the administration of the first dose in period 1 until the end-of-study visit
|
0.00%
0/16 • Adverse events were collected from the administration of the first dose in period 1 until the end-of-study visit
|
|
Investigations
Blood Calcium Decreased
|
5.6%
1/18 • Number of events 1 • Adverse events were collected from the administration of the first dose in period 1 until the end-of-study visit
|
0.00%
0/16 • Adverse events were collected from the administration of the first dose in period 1 until the end-of-study visit
|
0.00%
0/16 • Adverse events were collected from the administration of the first dose in period 1 until the end-of-study visit
|
0.00%
0/16 • Adverse events were collected from the administration of the first dose in period 1 until the end-of-study visit
|
0.00%
0/16 • Adverse events were collected from the administration of the first dose in period 1 until the end-of-study visit
|
|
Metabolism and nutrition disorders
Blood Creatinine Increased
|
0.00%
0/18 • Adverse events were collected from the administration of the first dose in period 1 until the end-of-study visit
|
0.00%
0/16 • Adverse events were collected from the administration of the first dose in period 1 until the end-of-study visit
|
6.2%
1/16 • Number of events 1 • Adverse events were collected from the administration of the first dose in period 1 until the end-of-study visit
|
0.00%
0/16 • Adverse events were collected from the administration of the first dose in period 1 until the end-of-study visit
|
0.00%
0/16 • Adverse events were collected from the administration of the first dose in period 1 until the end-of-study visit
|
|
Investigations
Blood Urine Present
|
0.00%
0/18 • Adverse events were collected from the administration of the first dose in period 1 until the end-of-study visit
|
0.00%
0/16 • Adverse events were collected from the administration of the first dose in period 1 until the end-of-study visit
|
0.00%
0/16 • Adverse events were collected from the administration of the first dose in period 1 until the end-of-study visit
|
0.00%
0/16 • Adverse events were collected from the administration of the first dose in period 1 until the end-of-study visit
|
6.2%
1/16 • Number of events 1 • Adverse events were collected from the administration of the first dose in period 1 until the end-of-study visit
|
|
Investigations
C-Reactive Protein Increased
|
5.6%
1/18 • Number of events 1 • Adverse events were collected from the administration of the first dose in period 1 until the end-of-study visit
|
0.00%
0/16 • Adverse events were collected from the administration of the first dose in period 1 until the end-of-study visit
|
0.00%
0/16 • Adverse events were collected from the administration of the first dose in period 1 until the end-of-study visit
|
0.00%
0/16 • Adverse events were collected from the administration of the first dose in period 1 until the end-of-study visit
|
0.00%
0/16 • Adverse events were collected from the administration of the first dose in period 1 until the end-of-study visit
|
|
Investigations
Hepatic Enzyme Increased
|
0.00%
0/18 • Adverse events were collected from the administration of the first dose in period 1 until the end-of-study visit
|
6.2%
1/16 • Number of events 1 • Adverse events were collected from the administration of the first dose in period 1 until the end-of-study visit
|
0.00%
0/16 • Adverse events were collected from the administration of the first dose in period 1 until the end-of-study visit
|
0.00%
0/16 • Adverse events were collected from the administration of the first dose in period 1 until the end-of-study visit
|
0.00%
0/16 • Adverse events were collected from the administration of the first dose in period 1 until the end-of-study visit
|
|
Investigations
Neutrophil Count Decreased
|
5.6%
1/18 • Number of events 1 • Adverse events were collected from the administration of the first dose in period 1 until the end-of-study visit
|
0.00%
0/16 • Adverse events were collected from the administration of the first dose in period 1 until the end-of-study visit
|
0.00%
0/16 • Adverse events were collected from the administration of the first dose in period 1 until the end-of-study visit
|
0.00%
0/16 • Adverse events were collected from the administration of the first dose in period 1 until the end-of-study visit
|
0.00%
0/16 • Adverse events were collected from the administration of the first dose in period 1 until the end-of-study visit
|
|
Gastrointestinal disorders
Abdominal Discomfort
|
0.00%
0/18 • Adverse events were collected from the administration of the first dose in period 1 until the end-of-study visit
|
0.00%
0/16 • Adverse events were collected from the administration of the first dose in period 1 until the end-of-study visit
|
0.00%
0/16 • Adverse events were collected from the administration of the first dose in period 1 until the end-of-study visit
|
0.00%
0/16 • Adverse events were collected from the administration of the first dose in period 1 until the end-of-study visit
|
6.2%
1/16 • Number of events 1 • Adverse events were collected from the administration of the first dose in period 1 until the end-of-study visit
|
|
Gastrointestinal disorders
Abdominal Distension
|
5.6%
1/18 • Number of events 1 • Adverse events were collected from the administration of the first dose in period 1 until the end-of-study visit
|
0.00%
0/16 • Adverse events were collected from the administration of the first dose in period 1 until the end-of-study visit
|
0.00%
0/16 • Adverse events were collected from the administration of the first dose in period 1 until the end-of-study visit
|
0.00%
0/16 • Adverse events were collected from the administration of the first dose in period 1 until the end-of-study visit
|
0.00%
0/16 • Adverse events were collected from the administration of the first dose in period 1 until the end-of-study visit
|
|
Gastrointestinal disorders
Abdominal Pain Lower
|
0.00%
0/18 • Adverse events were collected from the administration of the first dose in period 1 until the end-of-study visit
|
6.2%
1/16 • Number of events 1 • Adverse events were collected from the administration of the first dose in period 1 until the end-of-study visit
|
0.00%
0/16 • Adverse events were collected from the administration of the first dose in period 1 until the end-of-study visit
|
0.00%
0/16 • Adverse events were collected from the administration of the first dose in period 1 until the end-of-study visit
|
0.00%
0/16 • Adverse events were collected from the administration of the first dose in period 1 until the end-of-study visit
|
|
Nervous system disorders
Headache
|
5.6%
1/18 • Number of events 1 • Adverse events were collected from the administration of the first dose in period 1 until the end-of-study visit
|
6.2%
1/16 • Number of events 1 • Adverse events were collected from the administration of the first dose in period 1 until the end-of-study visit
|
0.00%
0/16 • Adverse events were collected from the administration of the first dose in period 1 until the end-of-study visit
|
0.00%
0/16 • Adverse events were collected from the administration of the first dose in period 1 until the end-of-study visit
|
6.2%
1/16 • Number of events 1 • Adverse events were collected from the administration of the first dose in period 1 until the end-of-study visit
|
|
General disorders
Asthenia
|
0.00%
0/18 • Adverse events were collected from the administration of the first dose in period 1 until the end-of-study visit
|
0.00%
0/16 • Adverse events were collected from the administration of the first dose in period 1 until the end-of-study visit
|
0.00%
0/16 • Adverse events were collected from the administration of the first dose in period 1 until the end-of-study visit
|
0.00%
0/16 • Adverse events were collected from the administration of the first dose in period 1 until the end-of-study visit
|
6.2%
1/16 • Number of events 1 • Adverse events were collected from the administration of the first dose in period 1 until the end-of-study visit
|
|
General disorders
Fatigue
|
5.6%
1/18 • Number of events 1 • Adverse events were collected from the administration of the first dose in period 1 until the end-of-study visit
|
0.00%
0/16 • Adverse events were collected from the administration of the first dose in period 1 until the end-of-study visit
|
0.00%
0/16 • Adverse events were collected from the administration of the first dose in period 1 until the end-of-study visit
|
0.00%
0/16 • Adverse events were collected from the administration of the first dose in period 1 until the end-of-study visit
|
0.00%
0/16 • Adverse events were collected from the administration of the first dose in period 1 until the end-of-study visit
|
|
General disorders
Pyrexia
|
0.00%
0/18 • Adverse events were collected from the administration of the first dose in period 1 until the end-of-study visit
|
0.00%
0/16 • Adverse events were collected from the administration of the first dose in period 1 until the end-of-study visit
|
0.00%
0/16 • Adverse events were collected from the administration of the first dose in period 1 until the end-of-study visit
|
0.00%
0/16 • Adverse events were collected from the administration of the first dose in period 1 until the end-of-study visit
|
6.2%
1/16 • Number of events 1 • Adverse events were collected from the administration of the first dose in period 1 until the end-of-study visit
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/18 • Adverse events were collected from the administration of the first dose in period 1 until the end-of-study visit
|
0.00%
0/16 • Adverse events were collected from the administration of the first dose in period 1 until the end-of-study visit
|
0.00%
0/16 • Adverse events were collected from the administration of the first dose in period 1 until the end-of-study visit
|
0.00%
0/16 • Adverse events were collected from the administration of the first dose in period 1 until the end-of-study visit
|
6.2%
1/16 • Number of events 1 • Adverse events were collected from the administration of the first dose in period 1 until the end-of-study visit
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
5.6%
1/18 • Number of events 1 • Adverse events were collected from the administration of the first dose in period 1 until the end-of-study visit
|
0.00%
0/16 • Adverse events were collected from the administration of the first dose in period 1 until the end-of-study visit
|
0.00%
0/16 • Adverse events were collected from the administration of the first dose in period 1 until the end-of-study visit
|
0.00%
0/16 • Adverse events were collected from the administration of the first dose in period 1 until the end-of-study visit
|
0.00%
0/16 • Adverse events were collected from the administration of the first dose in period 1 until the end-of-study visit
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
5.6%
1/18 • Number of events 1 • Adverse events were collected from the administration of the first dose in period 1 until the end-of-study visit
|
0.00%
0/16 • Adverse events were collected from the administration of the first dose in period 1 until the end-of-study visit
|
0.00%
0/16 • Adverse events were collected from the administration of the first dose in period 1 until the end-of-study visit
|
0.00%
0/16 • Adverse events were collected from the administration of the first dose in period 1 until the end-of-study visit
|
0.00%
0/16 • Adverse events were collected from the administration of the first dose in period 1 until the end-of-study visit
|
|
Eye disorders
Ocular Hyperaemia
|
0.00%
0/18 • Adverse events were collected from the administration of the first dose in period 1 until the end-of-study visit
|
0.00%
0/16 • Adverse events were collected from the administration of the first dose in period 1 until the end-of-study visit
|
6.2%
1/16 • Number of events 1 • Adverse events were collected from the administration of the first dose in period 1 until the end-of-study visit
|
0.00%
0/16 • Adverse events were collected from the administration of the first dose in period 1 until the end-of-study visit
|
0.00%
0/16 • Adverse events were collected from the administration of the first dose in period 1 until the end-of-study visit
|
|
Injury, poisoning and procedural complications
Procedural Dizziness
|
5.6%
1/18 • Number of events 1 • Adverse events were collected from the administration of the first dose in period 1 until the end-of-study visit
|
0.00%
0/16 • Adverse events were collected from the administration of the first dose in period 1 until the end-of-study visit
|
0.00%
0/16 • Adverse events were collected from the administration of the first dose in period 1 until the end-of-study visit
|
0.00%
0/16 • Adverse events were collected from the administration of the first dose in period 1 until the end-of-study visit
|
0.00%
0/16 • Adverse events were collected from the administration of the first dose in period 1 until the end-of-study visit
|
|
Renal and urinary disorders
Urine Odour Abnormal
|
0.00%
0/18 • Adverse events were collected from the administration of the first dose in period 1 until the end-of-study visit
|
0.00%
0/16 • Adverse events were collected from the administration of the first dose in period 1 until the end-of-study visit
|
0.00%
0/16 • Adverse events were collected from the administration of the first dose in period 1 until the end-of-study visit
|
6.2%
1/16 • Number of events 1 • Adverse events were collected from the administration of the first dose in period 1 until the end-of-study visit
|
0.00%
0/16 • Adverse events were collected from the administration of the first dose in period 1 until the end-of-study visit
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
0.00%
0/18 • Adverse events were collected from the administration of the first dose in period 1 until the end-of-study visit
|
0.00%
0/16 • Adverse events were collected from the administration of the first dose in period 1 until the end-of-study visit
|
6.2%
1/16 • Number of events 1 • Adverse events were collected from the administration of the first dose in period 1 until the end-of-study visit
|
0.00%
0/16 • Adverse events were collected from the administration of the first dose in period 1 until the end-of-study visit
|
0.00%
0/16 • Adverse events were collected from the administration of the first dose in period 1 until the end-of-study visit
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
0.00%
0/18 • Adverse events were collected from the administration of the first dose in period 1 until the end-of-study visit
|
0.00%
0/16 • Adverse events were collected from the administration of the first dose in period 1 until the end-of-study visit
|
6.2%
1/16 • Number of events 1 • Adverse events were collected from the administration of the first dose in period 1 until the end-of-study visit
|
0.00%
0/16 • Adverse events were collected from the administration of the first dose in period 1 until the end-of-study visit
|
0.00%
0/16 • Adverse events were collected from the administration of the first dose in period 1 until the end-of-study visit
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor retained title to and the right to publish all documentation, records, raw data, specimens or other work product generated in connection with the trial. Such publications shall not be made without the prior written consent of Sponsor. Neither Party will use the other Party's name in connection with any publication or promotion without the other Party's prior written consent. However, Sponsor has the right to publish appropriate information in order to satisfy regulatory requirements.
- Publication restrictions are in place
Restriction type: OTHER