Trial Outcomes & Findings for Ibuprofen 4% (w/v) Pivotal Bioequivalence Study (NCT NCT03496324)
NCT ID: NCT03496324
Last Updated: 2019-06-05
Results Overview
One Subject in Period 3 Reference (fasted) was not included in PK Parameter Summary Set as per statistical analysis plan (SAP) Population definitions.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
24 participants
Primary outcome timeframe
Pre-dose (Day -1), 10, 15, 20, 30, 40, 50, 60, 70, 80, 90, 105, 120, 180, 240, 360, 480 and 720 minutes (Day 0) post-dose
Results posted on
2019-06-05
Participant Flow
Study was conducted in single-site in the United Kingdom.
Total 71 subjects were screened. Of these, 38 subjects were screen failures, 2 were withdrew consent, 7 were reserve subjects. Subjects randomized were 24.
Participant milestones
| Measure |
Sequence 1-BACD: Test (Fed) - Nurofen for Children
B = Nurofen for Children® 400 mg/10 ml (Test fasted)
A = Nurofen for Children® 400 mg/10 ml (Test fed)
C = Algifor® Junior 400 mg/20 ml (Reference fed)
D = Algifor® Junior 400 mg/20 ml (Reference fasted)
|
Sequence 2-DCAB: Test (Fasted) - Nurofen for Children
D = Algifor® Junior 400 mg/20 ml (Reference fasted)
C = Algifor® Junior 400 mg/20 ml (Reference fed)
A = Nurofen for Children® 400 mg/10 ml (Test fed)
B = Nurofen for Children® 400 mg/10 ml (Test fasted)
|
Sequence 3-ADBC: Reference (Fed) - Algifor Junior
A = Nurofen for Children® 400 mg/10 ml (Test fed)
D = Algifor® Junior 400 mg/20 ml (Reference fasted)
B = Nurofen for Children® 400 mg/10 ml (Test fasted)
C = Algifor® Junior 400 mg/20 ml (Reference fed)
|
Sequence 4-CBDA: Reference (Fasted) - Algifor Junior
C = Algifor® Junior 400 mg/20 ml (Reference fed)
B = Nurofen for Children® 400 mg/10 ml (Test fasted)
D = Algifor® Junior 400 mg/20 ml (Reference fasted)
A = Nurofen for Children® 400 mg/10 ml (Test fed)
|
|---|---|---|---|---|
|
Period 1
STARTED
|
6
|
6
|
6
|
6
|
|
Period 1
COMPLETED
|
6
|
6
|
6
|
6
|
|
Period 1
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Period 1: Washout (3 to 7 Days)
STARTED
|
6
|
6
|
6
|
6
|
|
Period 1: Washout (3 to 7 Days)
COMPLETED
|
6
|
6
|
6
|
6
|
|
Period 1: Washout (3 to 7 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Period 2
STARTED
|
6
|
6
|
6
|
6
|
|
Period 2
COMPLETED
|
6
|
6
|
6
|
6
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Period 2: Washout (3 to 7 Days)
STARTED
|
6
|
6
|
6
|
6
|
|
Period 2: Washout (3 to 7 Days)
COMPLETED
|
6
|
6
|
6
|
6
|
|
Period 2: Washout (3 to 7 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Period 3
STARTED
|
6
|
6
|
6
|
6
|
|
Period 3
COMPLETED
|
6
|
6
|
6
|
6
|
|
Period 3
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Period 3: Washout (3 to 7 Days)
STARTED
|
6
|
6
|
6
|
6
|
|
Period 3: Washout (3 to 7 Days)
COMPLETED
|
6
|
6
|
6
|
6
|
|
Period 3: Washout (3 to 7 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Period 7: Period 4
STARTED
|
6
|
6
|
6
|
6
|
|
Period 7: Period 4
COMPLETED
|
6
|
6
|
6
|
6
|
|
Period 7: Period 4
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Ibuprofen 4% (w/v) Pivotal Bioequivalence Study
Baseline characteristics by cohort
| Measure |
Overall Study
n=24 Participants
Nurofen for Children® 400 mg/10 mL single-oral dose under fasted and fed conditions.
Algifor® Junior 400 mg/20 mL single-oral dose under fasted and fed conditions.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
24 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
|
Age, Continuous
|
29.5 years
STANDARD_DEVIATION 8.21 • n=93 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
22 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=93 Participants
|
|
Weight
|
68.68 kg
STANDARD_DEVIATION 11.506 • n=93 Participants
|
|
Height
|
1.692 meter
STANDARD_DEVIATION 0.0935 • n=93 Participants
|
|
Body Mass Index
|
23.82 kg/m²
STANDARD_DEVIATION 2.037 • n=93 Participants
|
PRIMARY outcome
Timeframe: Pre-dose (Day -1), 10, 15, 20, 30, 40, 50, 60, 70, 80, 90, 105, 120, 180, 240, 360, 480 and 720 minutes (Day 0) post-dosePopulation: Pharmacokinetics (PK) Parameter Summary Set population: All subjects from the PK dataset with evaluable PK parameters for each treatment period. (PK Dataset: All subjects from the safety population with evaluable plasma concentrations).
One Subject in Period 3 Reference (fasted) was not included in PK Parameter Summary Set as per statistical analysis plan (SAP) Population definitions.
Outcome measures
| Measure |
Reference (Fasted): Algifor Junior
n=23 Participants
Algifor® Junior 400 mg/20 ml by mouth under fasted condition.
Subjects participated in Treatment Sequence: BACD, DCAB, ADBC and CBDA.
Algifor® Junior: Algifor® Junior 400 mg/20 ml
|
Reference (Fed): Algifor Junior
n=24 Participants
Algifor® Junior 400 mg/20 ml by mouth under fed condition.
Subjects participated in Treatment Sequence: BACD, DCAB, ADBC and CBDA.
Algifor® Junior: Algifor® Junior 400 mg/20 ml
|
Test (Fasted): Nurofen for Children
n=24 Participants
Nurofen for Children® 400 mg/10 ml by mouth under fasted condition.
Subjects participated in Treatment Sequence: BACD, DCAB, ADBC and CBDA.
Nurofen for Children®: Nurofen for Children® 400 mg/10 ml
|
Test (Fed): Nurofen for Children
n=24 Participants
Nurofen for Children® 400 mg/10 ml by mouth under fed condition
Subjects participated in Treatment Sequence: BACD, DCAB, ADBC and CBDA.
Nurofen for Children®: Nurofen for Children® 400 mg/10 ml
|
|---|---|---|---|---|
|
Maximum Plasma Concentration (Cmax) of Ibuprofen
|
33.843 μg/ml
Standard Deviation 3.7858
|
26.432 μg/ml
Standard Deviation 6.129
|
38.503 μg/ml
Standard Deviation 7.5696
|
25.162 μg/ml
Standard Deviation 6.9668
|
PRIMARY outcome
Timeframe: Pre-dose (Day -1), 10, 15, 20, 30, 40, 50, 60, 70, 80, 90, 105, 120, 180, 240, 360, 480 and 720 minutes (Day 0) post-dosePopulation: PK Parameter Summary set population. One Subject in Period 3 Reference (fasted) was not included in PK Parameter Summary Set as per statistical analysis plan (SAP) Population definitions.
Outcome measures
| Measure |
Reference (Fasted): Algifor Junior
n=23 Participants
Algifor® Junior 400 mg/20 ml by mouth under fasted condition.
Subjects participated in Treatment Sequence: BACD, DCAB, ADBC and CBDA.
Algifor® Junior: Algifor® Junior 400 mg/20 ml
|
Reference (Fed): Algifor Junior
n=24 Participants
Algifor® Junior 400 mg/20 ml by mouth under fed condition.
Subjects participated in Treatment Sequence: BACD, DCAB, ADBC and CBDA.
Algifor® Junior: Algifor® Junior 400 mg/20 ml
|
Test (Fasted): Nurofen for Children
n=24 Participants
Nurofen for Children® 400 mg/10 ml by mouth under fasted condition.
Subjects participated in Treatment Sequence: BACD, DCAB, ADBC and CBDA.
Nurofen for Children®: Nurofen for Children® 400 mg/10 ml
|
Test (Fed): Nurofen for Children
n=24 Participants
Nurofen for Children® 400 mg/10 ml by mouth under fed condition
Subjects participated in Treatment Sequence: BACD, DCAB, ADBC and CBDA.
Nurofen for Children®: Nurofen for Children® 400 mg/10 ml
|
|---|---|---|---|---|
|
Area Under Plasma Concentration-time Curve From Administration to the Last Quantifiable Concentration at Time t (AUC0-t) of Ibuprofen
|
5960.054 min*μg/mL
Standard Deviation 832.1342
|
5482.340 min*μg/mL
Standard Deviation 827.2913
|
6169.662 min*μg/mL
Standard Deviation 1199.1785
|
5754.831 min*μg/mL
Standard Deviation 1056.5014
|
SECONDARY outcome
Timeframe: Pre-dose (Day -1), 10, 15, 20, 30, 40, 50, 60, 70, 80, 90, 105, 120, 180, 240, 360, 480 and 720 minutes (Day 0) post-dosePopulation: PK Parameter Summary set population. One Subject in Period 3 Reference (fasted) was not included in PK Parameter Summary Set as per statistical analysis plan (SAP) Population definitions.
Kel was calculated as the absolute value of the log-linear regression slope of the elimination phase (logged) over time (linear) using the post Cmax concentrations \[at least 3 non-below the limit of quantification (BLQ)\] that maximized the adjusted R2.
Outcome measures
| Measure |
Reference (Fasted): Algifor Junior
n=23 Participants
Algifor® Junior 400 mg/20 ml by mouth under fasted condition.
Subjects participated in Treatment Sequence: BACD, DCAB, ADBC and CBDA.
Algifor® Junior: Algifor® Junior 400 mg/20 ml
|
Reference (Fed): Algifor Junior
n=24 Participants
Algifor® Junior 400 mg/20 ml by mouth under fed condition.
Subjects participated in Treatment Sequence: BACD, DCAB, ADBC and CBDA.
Algifor® Junior: Algifor® Junior 400 mg/20 ml
|
Test (Fasted): Nurofen for Children
n=24 Participants
Nurofen for Children® 400 mg/10 ml by mouth under fasted condition.
Subjects participated in Treatment Sequence: BACD, DCAB, ADBC and CBDA.
Nurofen for Children®: Nurofen for Children® 400 mg/10 ml
|
Test (Fed): Nurofen for Children
n=24 Participants
Nurofen for Children® 400 mg/10 ml by mouth under fed condition
Subjects participated in Treatment Sequence: BACD, DCAB, ADBC and CBDA.
Nurofen for Children®: Nurofen for Children® 400 mg/10 ml
|
|---|---|---|---|---|
|
Elimination Rate Constant (Kel) of Ibuprofen
|
0.00668 1/min
Standard Deviation 0.000763
|
0.00577 1/min
Standard Deviation 0.000865
|
0.00646 1/min
Standard Deviation 0.000763
|
0.00532 1/min
Standard Deviation 0.00119
|
SECONDARY outcome
Timeframe: Pre-dose (Day -1), 10, 15, 20, 30, 40, 50, 60, 70, 80, 90, 105, 120, 180, 240, 360, 480 and 720 minutes (Day 0) post-dosePopulation: PK Parameter Summary set population. One Subject in Period 3 Reference (fasted) was not included in PK Parameter Summary Set as per statistical analysis plan (SAP) Population definitions.
AUC0-inf was calculated as AUC0-t + (Ct/Kel) where Ct was the last quantifiable concentration at time t.
Outcome measures
| Measure |
Reference (Fasted): Algifor Junior
n=23 Participants
Algifor® Junior 400 mg/20 ml by mouth under fasted condition.
Subjects participated in Treatment Sequence: BACD, DCAB, ADBC and CBDA.
Algifor® Junior: Algifor® Junior 400 mg/20 ml
|
Reference (Fed): Algifor Junior
n=24 Participants
Algifor® Junior 400 mg/20 ml by mouth under fed condition.
Subjects participated in Treatment Sequence: BACD, DCAB, ADBC and CBDA.
Algifor® Junior: Algifor® Junior 400 mg/20 ml
|
Test (Fasted): Nurofen for Children
n=24 Participants
Nurofen for Children® 400 mg/10 ml by mouth under fasted condition.
Subjects participated in Treatment Sequence: BACD, DCAB, ADBC and CBDA.
Nurofen for Children®: Nurofen for Children® 400 mg/10 ml
|
Test (Fed): Nurofen for Children
n=24 Participants
Nurofen for Children® 400 mg/10 ml by mouth under fed condition
Subjects participated in Treatment Sequence: BACD, DCAB, ADBC and CBDA.
Nurofen for Children®: Nurofen for Children® 400 mg/10 ml
|
|---|---|---|---|---|
|
Area Under Plasma Concentration-time Curve From Administration to Infinity (AUC0-inf) of Ibuprofen
|
6032.841 min*μg/mL
Standard Deviation 843.8379
|
5609.733 min*μg/mL
Standard Deviation 862.2304
|
6255.821 min*μg/mL
Standard Deviation 1229.6414
|
5982.084 min*μg/mL
Standard Deviation 1118.9361
|
SECONDARY outcome
Timeframe: Pre-dose (Day -1), 10, 15, 20, 30, 40, 50, 60, 70, 80, 90, 105, 120, 180, 240, 360, 480 and 720 minutes (Day 0) post-dosePopulation: PK Parameter Summary set population. One Subject in Period 3 Reference (fasted) was not included in PK Parameter Summary Set as per statistical analysis plan (SAP) Population definitions.
Outcome measures
| Measure |
Reference (Fasted): Algifor Junior
n=23 Participants
Algifor® Junior 400 mg/20 ml by mouth under fasted condition.
Subjects participated in Treatment Sequence: BACD, DCAB, ADBC and CBDA.
Algifor® Junior: Algifor® Junior 400 mg/20 ml
|
Reference (Fed): Algifor Junior
n=24 Participants
Algifor® Junior 400 mg/20 ml by mouth under fed condition.
Subjects participated in Treatment Sequence: BACD, DCAB, ADBC and CBDA.
Algifor® Junior: Algifor® Junior 400 mg/20 ml
|
Test (Fasted): Nurofen for Children
n=24 Participants
Nurofen for Children® 400 mg/10 ml by mouth under fasted condition.
Subjects participated in Treatment Sequence: BACD, DCAB, ADBC and CBDA.
Nurofen for Children®: Nurofen for Children® 400 mg/10 ml
|
Test (Fed): Nurofen for Children
n=24 Participants
Nurofen for Children® 400 mg/10 ml by mouth under fed condition
Subjects participated in Treatment Sequence: BACD, DCAB, ADBC and CBDA.
Nurofen for Children®: Nurofen for Children® 400 mg/10 ml
|
|---|---|---|---|---|
|
Ratio of AUC0-t/AUC0-inf (AUCR)
|
0.988 Ratio
Standard Deviation 0.0052
|
0.978 Ratio
Standard Deviation 0.0142
|
0.987 Ratio
Standard Deviation 0.0066
|
0.963 Ratio
Standard Deviation 0.0384
|
SECONDARY outcome
Timeframe: Pre-dose (Day -1), 10, 15, 20, 30, 40, 50, 60, 70, 80, 90, 105, 120, 180, 240, 360, 480 and 720 minutes (Day 0) post-dosePopulation: PK Parameter Summary set population. One Subject in Period 3 Reference (fasted) was not included in PK Parameter Summary Set as per statistical analysis plan (SAP) Population definitions.
Outcome measures
| Measure |
Reference (Fasted): Algifor Junior
n=23 Participants
Algifor® Junior 400 mg/20 ml by mouth under fasted condition.
Subjects participated in Treatment Sequence: BACD, DCAB, ADBC and CBDA.
Algifor® Junior: Algifor® Junior 400 mg/20 ml
|
Reference (Fed): Algifor Junior
n=24 Participants
Algifor® Junior 400 mg/20 ml by mouth under fed condition.
Subjects participated in Treatment Sequence: BACD, DCAB, ADBC and CBDA.
Algifor® Junior: Algifor® Junior 400 mg/20 ml
|
Test (Fasted): Nurofen for Children
n=24 Participants
Nurofen for Children® 400 mg/10 ml by mouth under fasted condition.
Subjects participated in Treatment Sequence: BACD, DCAB, ADBC and CBDA.
Nurofen for Children®: Nurofen for Children® 400 mg/10 ml
|
Test (Fed): Nurofen for Children
n=24 Participants
Nurofen for Children® 400 mg/10 ml by mouth under fed condition
Subjects participated in Treatment Sequence: BACD, DCAB, ADBC and CBDA.
Nurofen for Children®: Nurofen for Children® 400 mg/10 ml
|
|---|---|---|---|---|
|
Time to Maximum Plasma Concentration (Tmax) of Ibuprofen
|
65 min
Standard Deviation 33.81
|
74.9 min
Standard Deviation 42.66
|
60.4 min
Standard Deviation 43.59
|
65.8 min
Standard Deviation 24.79
|
SECONDARY outcome
Timeframe: Pre-dose (Day -1), 10, 15, 20, 30, 40, 50, 60, 70, 80, 90, 105, 120, 180, 240, 360, 480 and 720 minutes (Day 0) post-dosePopulation: PK Parameter Summary set population. One Subject in Period 3 Reference (fasted) was not included in PK Parameter Summary Set as per statistical analysis plan (SAP) Population definitions.
Outcome measures
| Measure |
Reference (Fasted): Algifor Junior
n=23 Participants
Algifor® Junior 400 mg/20 ml by mouth under fasted condition.
Subjects participated in Treatment Sequence: BACD, DCAB, ADBC and CBDA.
Algifor® Junior: Algifor® Junior 400 mg/20 ml
|
Reference (Fed): Algifor Junior
n=24 Participants
Algifor® Junior 400 mg/20 ml by mouth under fed condition.
Subjects participated in Treatment Sequence: BACD, DCAB, ADBC and CBDA.
Algifor® Junior: Algifor® Junior 400 mg/20 ml
|
Test (Fasted): Nurofen for Children
n=24 Participants
Nurofen for Children® 400 mg/10 ml by mouth under fasted condition.
Subjects participated in Treatment Sequence: BACD, DCAB, ADBC and CBDA.
Nurofen for Children®: Nurofen for Children® 400 mg/10 ml
|
Test (Fed): Nurofen for Children
n=24 Participants
Nurofen for Children® 400 mg/10 ml by mouth under fed condition
Subjects participated in Treatment Sequence: BACD, DCAB, ADBC and CBDA.
Nurofen for Children®: Nurofen for Children® 400 mg/10 ml
|
|---|---|---|---|---|
|
Plasma Concentration Half-life (T1/2) of Ibuprofen
|
104.975 min
Standard Deviation 11.6362
|
122.752 min
Standard Deviation 19.338
|
108.854 min
Standard Deviation 13.1303
|
138.894 min
Standard Deviation 41.0392
|
SECONDARY outcome
Timeframe: Up to Day 7 (follow-up)Population: Safety population: All subjects who received at least 1 dose of IMP.
Mild = Adverse event (AE) did not limit usual activities; subject may have experienced slight discomfort. Moderate = AE resulted in some limitation of usual activities; subject may have experienced significant discomfort. Severe = AE resulted in an inability to carry out usual activities; subject may have experienced intolerable discomfort/pain. Unassessable/Unclassified = Insufficient information to be able to make an assessment Conditional/ Unclassified = Insufficient information to make an assessment at present Unrelated = No possibility that the AE was caused by the IMP Unlikely = Slight, but remote, chance that the AE was caused by the IMP, but the balance of judgment was that it was most likely not due to the investigational medicinal product (IMP). Possible = Reasonable suspicion that the AE was caused by the IMP Probable = Most likely that the AE was caused by the IMP Certain = AE was definitely caused by the IMP
Outcome measures
| Measure |
Reference (Fasted): Algifor Junior
n=24 Participants
Algifor® Junior 400 mg/20 ml by mouth under fasted condition.
Subjects participated in Treatment Sequence: BACD, DCAB, ADBC and CBDA.
Algifor® Junior: Algifor® Junior 400 mg/20 ml
|
Reference (Fed): Algifor Junior
n=24 Participants
Algifor® Junior 400 mg/20 ml by mouth under fed condition.
Subjects participated in Treatment Sequence: BACD, DCAB, ADBC and CBDA.
Algifor® Junior: Algifor® Junior 400 mg/20 ml
|
Test (Fasted): Nurofen for Children
n=24 Participants
Nurofen for Children® 400 mg/10 ml by mouth under fasted condition.
Subjects participated in Treatment Sequence: BACD, DCAB, ADBC and CBDA.
Nurofen for Children®: Nurofen for Children® 400 mg/10 ml
|
Test (Fed): Nurofen for Children
n=24 Participants
Nurofen for Children® 400 mg/10 ml by mouth under fed condition
Subjects participated in Treatment Sequence: BACD, DCAB, ADBC and CBDA.
Nurofen for Children®: Nurofen for Children® 400 mg/10 ml
|
|---|---|---|---|---|
|
Number of Subjects With Treatment Emergent Adverse Events (TEAEs)
Treatment Emergent Adverse Event (TEAE)
|
1 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
|
Number of Subjects With Treatment Emergent Adverse Events (TEAEs)
Serious TEAE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Treatment Emergent Adverse Events (TEAEs)
TEAE Leading to Withdrawal
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Treatment Emergent Adverse Events (TEAEs)
TEAE by severity: Mild
|
1 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
|
Number of Subjects With Treatment Emergent Adverse Events (TEAEs)
TEAE by severity: Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Treatment Emergent Adverse Events (TEAEs)
TEAE by severity: Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Treatment Emergent Adverse Events (TEAEs)
Relationship to IMP - Certain
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Treatment Emergent Adverse Events (TEAEs)
Relationship to IMP - Probable
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Treatment Emergent Adverse Events (TEAEs)
Relationship to IMP - Possible
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Treatment Emergent Adverse Events (TEAEs)
Relationship to IMP - Unlikely
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Treatment Emergent Adverse Events (TEAEs)
Relationship to IMP - Unrelated
|
1 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
|
Number of Subjects With Treatment Emergent Adverse Events (TEAEs)
Relationship to IMP - Conditional/Unclassified
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Treatment Emergent Adverse Events (TEAEs)
Relationship to IMP - Unassessable/Unclassifiable
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Test (Fasted): Nurofen for Children
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Test (Fed): Nurofen for Children
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Reference (Fasted): Algifor Junior
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Reference (Fed): Algifor Junior
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Test (Fasted): Nurofen for Children
n=24 participants at risk
Nurofen for Children® 400 mg/10 ml by mouth under fasted condition.
Subjects participated in Treatment Sequence: BACD, DCAB, ADBC and CBDA.
Nurofen for Children®: Nurofen for Children® 400 mg/10 ml
|
Test (Fed): Nurofen for Children
n=24 participants at risk
Nurofen for Children® 400 mg/10 ml by mouth under fed condition
Subjects participated in Treatment Sequence: BACD, DCAB, ADBC and CBDA.
Nurofen for Children®: Nurofen for Children® 400 mg/10 ml
|
Reference (Fasted): Algifor Junior
n=24 participants at risk
Algifor® Junior 400 mg/20 ml by mouth under fasted condition.
Subjects participated in Treatment Sequence: BACD, DCAB, ADBC and CBDA.
Algifor® Junior: Algifor® Junior 400 mg/20 ml
|
Reference (Fed): Algifor Junior
n=24 participants at risk
Algifor® Junior 400 mg/20 ml by mouth under fed condition.
Subjects participated in Treatment Sequence: BACD, DCAB, ADBC and CBDA.
Algifor® Junior: Algifor® Junior 400 mg/20 ml
|
|---|---|---|---|---|
|
Nervous system disorders
Headache
|
4.2%
1/24 • Number of events 2 • Up to Day 7 (Follow-up)
|
4.2%
1/24 • Number of events 1 • Up to Day 7 (Follow-up)
|
4.2%
1/24 • Number of events 1 • Up to Day 7 (Follow-up)
|
0.00%
0/24 • Up to Day 7 (Follow-up)
|
|
Infections and infestations
Nasopharyngitis
|
4.2%
1/24 • Number of events 1 • Up to Day 7 (Follow-up)
|
0.00%
0/24 • Up to Day 7 (Follow-up)
|
0.00%
0/24 • Up to Day 7 (Follow-up)
|
0.00%
0/24 • Up to Day 7 (Follow-up)
|
Additional Information
Clinical Research Director, Clinical Research
Reckitt Benckiser Healthcare (UK) Ltd
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place