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Trial Outcomes & Findings for Ibuprofen Suspension Bioequivalence Study (NCT NCT02503085)

NCT ID: NCT02503085

Last Updated: 2018-04-13

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

28 participants

Primary outcome timeframe

Pre-dose, 10, 15, 20, 30, 40, 50, 60, 70, 80, 90, 105, 120, 180, 240, 360, 480, 720 and 1440 mins (Day 1, Post-dose)

Results posted on

2018-04-13

Participant Flow

Total 60 subjects were screened and among them 16 subjects were screen failure, 2 subjects withdrew consent and 14 subjects were reserve.

Participant milestones

Participant milestones
Measure
Sequence 1-BACD: Nurofen for Children® - Algifor Dolo Junior®
B = Nurofen for Children® suspension 400 mg/20 mL single-oral dose under fasted condition. A = Nurofen for Children® suspension 400 mg/20 mL single-oral dose under fed condition. C = Algifor Dolo Junior® suspension 400 mg/20 mL single-oral dose under fed condition. D = Algifor Dolo Junior® suspension 400 mg/20 mL single-oral dose under fasted condition.
Sequence 2-DCAB: Nurofen for Children® - Algifor Dolo Junior®
D = Algifor Dolo Junior® suspension 400 mg/20 mL single-oral dose under fasted condition. C = Algifor Dolo Junior® suspension 400 mg/20 mL single-oral dose under fed condition. A = Nurofen for Children® suspension 400 mg/20 mL single-oral dose under fed condition. B = Nurofen for Children® suspension 400 mg/20 mL single-oral dose under fasted condition.
Sequence 3-CBDA: Nurofen for Children® - Algifor Dolo Junior®
C = Algifor Dolo Junior® suspension 400 mg/20 mL single-oral dose under fed condition. B = Nurofen for Children® suspension 400 mg/20 mL single-oral dose under fasted condition. D = Algifor Dolo Junior® suspension 400 mg/20 mL single-oral dose under fasted condition. A = Nurofen for Children® suspension 400 mg/20 mL single-oral dose under fed condition.
Sequence 4-ADBC: Nurofen for Children® - Algifor Dolo Junior®
A = Nurofen for Children® suspension 400 mg/20 mL single-oral dose under fed condition. D = Algifor Dolo Junior® suspension 400 mg/20 mL single-oral dose under fasted condition. B = Nurofen for Children® suspension 400 mg/20 mL single-oral dose under fasted condition. C = Algifor Dolo Junior® suspension 400 mg/20 mL single-oral dose under fed condition.
Period 1
STARTED
7
7
7
7
Period 1
COMPLETED
7
7
7
7
Period 1
NOT COMPLETED
0
0
0
0
Period 1: Washout (3 to 7 Days)
STARTED
7
7
7
7
Period 1: Washout (3 to 7 Days)
COMPLETED
7
7
7
7
Period 1: Washout (3 to 7 Days)
NOT COMPLETED
0
0
0
0
Period 2
STARTED
7
7
7
7
Period 2
COMPLETED
7
7
7
7
Period 2
NOT COMPLETED
0
0
0
0
Period 2: Washout (3 to 7 Days)
STARTED
7
7
7
7
Period 2: Washout (3 to 7 Days)
COMPLETED
6
7
6
7
Period 2: Washout (3 to 7 Days)
NOT COMPLETED
1
0
1
0
Period 3
STARTED
6
7
6
7
Period 3
COMPLETED
6
7
6
7
Period 3
NOT COMPLETED
0
0
0
0
Period 3: Washout (3 to 7 Days)
STARTED
6
7
6
7
Period 3: Washout (3 to 7 Days)
COMPLETED
6
7
6
7
Period 3: Washout (3 to 7 Days)
NOT COMPLETED
0
0
0
0
Period 4
STARTED
6
7
6
7
Period 4
COMPLETED
6
7
6
7
Period 4
NOT COMPLETED
0
0
0
0

Reasons for withdrawal

Reasons for withdrawal
Measure
Sequence 1-BACD: Nurofen for Children® - Algifor Dolo Junior®
B = Nurofen for Children® suspension 400 mg/20 mL single-oral dose under fasted condition. A = Nurofen for Children® suspension 400 mg/20 mL single-oral dose under fed condition. C = Algifor Dolo Junior® suspension 400 mg/20 mL single-oral dose under fed condition. D = Algifor Dolo Junior® suspension 400 mg/20 mL single-oral dose under fasted condition.
Sequence 2-DCAB: Nurofen for Children® - Algifor Dolo Junior®
D = Algifor Dolo Junior® suspension 400 mg/20 mL single-oral dose under fasted condition. C = Algifor Dolo Junior® suspension 400 mg/20 mL single-oral dose under fed condition. A = Nurofen for Children® suspension 400 mg/20 mL single-oral dose under fed condition. B = Nurofen for Children® suspension 400 mg/20 mL single-oral dose under fasted condition.
Sequence 3-CBDA: Nurofen for Children® - Algifor Dolo Junior®
C = Algifor Dolo Junior® suspension 400 mg/20 mL single-oral dose under fed condition. B = Nurofen for Children® suspension 400 mg/20 mL single-oral dose under fasted condition. D = Algifor Dolo Junior® suspension 400 mg/20 mL single-oral dose under fasted condition. A = Nurofen for Children® suspension 400 mg/20 mL single-oral dose under fed condition.
Sequence 4-ADBC: Nurofen for Children® - Algifor Dolo Junior®
A = Nurofen for Children® suspension 400 mg/20 mL single-oral dose under fed condition. D = Algifor Dolo Junior® suspension 400 mg/20 mL single-oral dose under fasted condition. B = Nurofen for Children® suspension 400 mg/20 mL single-oral dose under fasted condition. C = Algifor Dolo Junior® suspension 400 mg/20 mL single-oral dose under fed condition.
Period 2: Washout (3 to 7 Days)
Adverse Event
1
0
1
0

Baseline Characteristics

Ibuprofen Suspension Bioequivalence Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Overall Study
n=28 Participants
Nurofen for Children® suspension 400 mg/20 mL single-oral dose under fasted and fed conditions. Algifor Dolo Junior® suspension 400 mg/20 mL single-oral dose under fasted and fed conditions.
Age, Continuous
31.46 years
STANDARD_DEVIATION 8.660 • n=99 Participants
Sex: Female, Male
Female
13 Participants
n=99 Participants
Sex: Female, Male
Male
15 Participants
n=99 Participants
Race/Ethnicity, Customized
Caucasian
28 Participants
n=99 Participants
Region of Enrollment
United Kingdom
28 Participants
n=99 Participants
Weight
70.88 kg
STANDARD_DEVIATION 10.909 • n=99 Participants
Height
1.711 m
STANDARD_DEVIATION 0.1000 • n=99 Participants
Body Mass Index (BMI)
24.07 kg/m²
STANDARD_DEVIATION 1.884 • n=99 Participants

PRIMARY outcome

Timeframe: Pre-dose, 10, 15, 20, 30, 40, 50, 60, 70, 80, 90, 105, 120, 180, 240, 360, 480, 720 and 1440 mins (Day 1, Post-dose)

Population: Analysis population included only subjects with evaluable plasma concentrations per treatment and who had taken at least one dose of medication in each treatment groups.

Outcome measures

Outcome measures
Measure
Treatment B: Nurofen for Children® 400 mg/20 mL (Fasted)
n=27 Participants
Nurofen for Children® suspension 400 mg/20 mL single-oral dose under fasted condition.
Treatment A: Nurofen for Children® 400 mg/20 mL (Fed)
n=28 Participants
Nurofen for Children® suspension 400 mg/20 mL single-oral dose under fed condition.
Treatment D: Algifor Dolo Junior® 400 mg/20 mL (Fasted)
n=27 Participants
Algifor Dolo Junior® suspension 400 mg/20 mL single-oral dose under fasted condition.
Treatment C: Algifor Dolo Junior® 400 mg/20 mL (Fed)
n=26 Participants
Algifor Dolo Junior® suspension 400 mg/20 mL single-oral dose under fed condition.
Maximum Plasma Concentration (Cmax)
37499.938 ng/mL
Standard Deviation 8983.3020
26207.273 ng/mL
Standard Deviation 5788.1116
34752.646 ng/mL
Standard Deviation 5205.5859
26377.382 ng/mL
Standard Deviation 7496.1966

PRIMARY outcome

Timeframe: Pre-dose, 10, 15, 20, 30, 40, 50, 60, 70, 80, 90, 105, 120, 180, 240, 360, 480, 720 and 1440 mins (Day 1, Post-dose)

Population: Analysis population included only subjects with evaluable plasma concentrations per treatment and who had taken at least one dose of medication in each treatment groups.

Outcome measures

Outcome measures
Measure
Treatment B: Nurofen for Children® 400 mg/20 mL (Fasted)
n=27 Participants
Nurofen for Children® suspension 400 mg/20 mL single-oral dose under fasted condition.
Treatment A: Nurofen for Children® 400 mg/20 mL (Fed)
n=28 Participants
Nurofen for Children® suspension 400 mg/20 mL single-oral dose under fed condition.
Treatment D: Algifor Dolo Junior® 400 mg/20 mL (Fasted)
n=27 Participants
Algifor Dolo Junior® suspension 400 mg/20 mL single-oral dose under fasted condition.
Treatment C: Algifor Dolo Junior® 400 mg/20 mL (Fed)
n=26 Participants
Algifor Dolo Junior® suspension 400 mg/20 mL single-oral dose under fed condition.
Area Under the Plasma Concentration-time Curve From Administration to the Last Quantifiable Concentration at Time t (AUC0-t)
6139350.787 min*ng/mL
Standard Deviation 1315534.5598
5783712.850 min*ng/mL
Standard Deviation 1251017.0271
5912050.421 min*ng/mL
Standard Deviation 1353655.3076
5639716.354 min*ng/mL
Standard Deviation 1533625.9496

SECONDARY outcome

Timeframe: Pre-dose, 10, 15, 20, 30, 40, 50, 60, 70, 80, 90, 105, 120, 180, 240, 360, 480, 720 and 1440 mins (Day 1, Post-dose)

Population: Analysis population included only subjects with evaluable plasma concentrations per treatment and who had taken at least one dose of medication in each treatment groups.

Outcome measures

Outcome measures
Measure
Treatment B: Nurofen for Children® 400 mg/20 mL (Fasted)
n=27 Participants
Nurofen for Children® suspension 400 mg/20 mL single-oral dose under fasted condition.
Treatment A: Nurofen for Children® 400 mg/20 mL (Fed)
n=28 Participants
Nurofen for Children® suspension 400 mg/20 mL single-oral dose under fed condition.
Treatment D: Algifor Dolo Junior® 400 mg/20 mL (Fasted)
n=27 Participants
Algifor Dolo Junior® suspension 400 mg/20 mL single-oral dose under fasted condition.
Treatment C: Algifor Dolo Junior® 400 mg/20 mL (Fed)
n=26 Participants
Algifor Dolo Junior® suspension 400 mg/20 mL single-oral dose under fed condition.
Elimination Rate Constant (Kel)
0.00599 1/min
Standard Deviation 0.001238
0.00533 1/min
Standard Deviation 0.001142
0.00602 1/min
Standard Deviation 0.001221
0.00557 1/min
Standard Deviation 0.001156

SECONDARY outcome

Timeframe: Pre-dose, 10, 15, 20, 30, 40, 50, 60, 70, 80, 90, 105, 120, 180, 240, 360, 480, 720 and 1440 mins (Day 1, Post-dose)

Population: Analysis population included only subjects with evaluable plasma concentrations per treatment and who had taken at least one dose of medication in each treatment groups.

AUC0-inf = AUC0-t + (Ct/Kel), where Ct was the last quantifiable concentration at time t.

Outcome measures

Outcome measures
Measure
Treatment B: Nurofen for Children® 400 mg/20 mL (Fasted)
n=27 Participants
Nurofen for Children® suspension 400 mg/20 mL single-oral dose under fasted condition.
Treatment A: Nurofen for Children® 400 mg/20 mL (Fed)
n=28 Participants
Nurofen for Children® suspension 400 mg/20 mL single-oral dose under fed condition.
Treatment D: Algifor Dolo Junior® 400 mg/20 mL (Fasted)
n=27 Participants
Algifor Dolo Junior® suspension 400 mg/20 mL single-oral dose under fasted condition.
Treatment C: Algifor Dolo Junior® 400 mg/20 mL (Fed)
n=26 Participants
Algifor Dolo Junior® suspension 400 mg/20 mL single-oral dose under fed condition.
AUC From Administration to Infinity (AUC0-inf)
6215205.302 min*ng/mL
Standard Deviation 1324821.9469
5927787.749 min*ng/mL
Standard Deviation 1283566.5280
5986690.115 min*ng/mL
Standard Deviation 1379614.0039
5733877.552 min*ng/mL
Standard Deviation 1536788.1908

SECONDARY outcome

Timeframe: Pre-dose, 10, 15, 20, 30, 40, 50, 60, 70, 80, 90, 105, 120, 180, 240, 360, 480, 720 and 1440 mins (Day 1, Post-dose)

Population: Analysis population included only subjects with evaluable plasma concentrations per treatment and who had taken at least one dose of medication in each treatment groups.

Outcome measures

Outcome measures
Measure
Treatment B: Nurofen for Children® 400 mg/20 mL (Fasted)
n=27 Participants
Nurofen for Children® suspension 400 mg/20 mL single-oral dose under fasted condition.
Treatment A: Nurofen for Children® 400 mg/20 mL (Fed)
n=28 Participants
Nurofen for Children® suspension 400 mg/20 mL single-oral dose under fed condition.
Treatment D: Algifor Dolo Junior® 400 mg/20 mL (Fasted)
n=27 Participants
Algifor Dolo Junior® suspension 400 mg/20 mL single-oral dose under fasted condition.
Treatment C: Algifor Dolo Junior® 400 mg/20 mL (Fed)
n=26 Participants
Algifor Dolo Junior® suspension 400 mg/20 mL single-oral dose under fed condition.
Ratio of AUC0-t/AUC0-inf (AUCR)
0.988 Ratio
Standard Deviation 0.0059
0.976 Ratio
Standard Deviation 0.0184
0.988 Ratio
Standard Deviation 0.0074
0.983 Ratio
Standard Deviation 0.0118

SECONDARY outcome

Timeframe: Pre-dose, 10, 15, 20, 30, 40, 50, 60, 70, 80, 90, 105, 120, 180, 240, 360, 480, 720 and 1440 mins (Day 1, Post-dose)

Population: Analysis population included only subjects with evaluable plasma concentrations per treatment and who had taken at least one dose of medication in each treatment groups.

Outcome measures

Outcome measures
Measure
Treatment B: Nurofen for Children® 400 mg/20 mL (Fasted)
n=27 Participants
Nurofen for Children® suspension 400 mg/20 mL single-oral dose under fasted condition.
Treatment A: Nurofen for Children® 400 mg/20 mL (Fed)
n=28 Participants
Nurofen for Children® suspension 400 mg/20 mL single-oral dose under fed condition.
Treatment D: Algifor Dolo Junior® 400 mg/20 mL (Fasted)
n=27 Participants
Algifor Dolo Junior® suspension 400 mg/20 mL single-oral dose under fasted condition.
Treatment C: Algifor Dolo Junior® 400 mg/20 mL (Fed)
n=26 Participants
Algifor Dolo Junior® suspension 400 mg/20 mL single-oral dose under fed condition.
Time to Cmax (Tmax)
46.4 min
Standard Deviation 17.33
72.0 min
Standard Deviation 33.70
52.3 min
Standard Deviation 40.91
71.7 min
Standard Deviation 48.72

SECONDARY outcome

Timeframe: Pre-dose, 10, 15, 20, 30, 40, 50, 60, 70, 80, 90, 105, 120, 180, 240, 360, 480, 720 and 1440 mins (Day 1, Post-dose)

Population: Analysis population included only subjects with evaluable plasma concentrations per treatment and who had taken at least one dose of medication in each treatment groups.

Terminal elimination half-life (T1/2) = ln(2)/Kel

Outcome measures

Outcome measures
Measure
Treatment B: Nurofen for Children® 400 mg/20 mL (Fasted)
n=27 Participants
Nurofen for Children® suspension 400 mg/20 mL single-oral dose under fasted condition.
Treatment A: Nurofen for Children® 400 mg/20 mL (Fed)
n=28 Participants
Nurofen for Children® suspension 400 mg/20 mL single-oral dose under fed condition.
Treatment D: Algifor Dolo Junior® 400 mg/20 mL (Fasted)
n=27 Participants
Algifor Dolo Junior® suspension 400 mg/20 mL single-oral dose under fasted condition.
Treatment C: Algifor Dolo Junior® 400 mg/20 mL (Fed)
n=26 Participants
Algifor Dolo Junior® suspension 400 mg/20 mL single-oral dose under fed condition.
Plasma Concentration Half-life (T1/2)
121.122 min
Standard Deviation 28.6677
137.555 min
Standard Deviation 37.6325
120.879 min
Standard Deviation 30.5194
130.460 min
Standard Deviation 30.7138

SECONDARY outcome

Timeframe: Pre-dose, 10, 15, 20, 30, 40, 50, 60, 70, 80, 90, 105, 120, 180, 240, 360, 480, 720 and 1440 mins (Day 1, Post-dose)

Population: Analysis population included only subjects with evaluable plasma concentrations per treatment and who had taken at least one dose of medication in each treatment groups.

Cn was derived using linear interpolation from the 2 samples taken either side of the nominal time where there was a sampling time deviation. For concentrations that were missing due to blood samples not being taken Cn was not derived.

Outcome measures

Outcome measures
Measure
Treatment B: Nurofen for Children® 400 mg/20 mL (Fasted)
n=27 Participants
Nurofen for Children® suspension 400 mg/20 mL single-oral dose under fasted condition.
Treatment A: Nurofen for Children® 400 mg/20 mL (Fed)
n=28 Participants
Nurofen for Children® suspension 400 mg/20 mL single-oral dose under fed condition.
Treatment D: Algifor Dolo Junior® 400 mg/20 mL (Fasted)
n=27 Participants
Algifor Dolo Junior® suspension 400 mg/20 mL single-oral dose under fasted condition.
Treatment C: Algifor Dolo Junior® 400 mg/20 mL (Fed)
n=26 Participants
Algifor Dolo Junior® suspension 400 mg/20 mL single-oral dose under fed condition.
Plasma Concentration at Each Planned Nominal Time-point (Cn)
Time Post-Dose - 15 min
12315.358 ng/mL
Standard Deviation 10819.4956
8486.946 ng/mL
Standard Deviation 9318.9385
12251.837 ng/mL
Standard Deviation 9535.7628
8566.950 ng/mL
Standard Deviation 8227.2989
Plasma Concentration at Each Planned Nominal Time-point (Cn)
Time Post-Dose - 1440 min
127.547 ng/mL
Standard Deviation 34.2600
149.707 ng/mL
Standard Deviation 36.4129
189.103 ng/mL
Standard Deviation 85.3662
145.298 ng/mL
Standard Deviation 15.3467
Plasma Concentration at Each Planned Nominal Time-point (Cn)
Time Post-Dose - 10 min
5934.077 ng/mL
Standard Deviation 6885.8643
5473.173 ng/mL
Standard Deviation 7955.4756
5579.436 ng/mL
Standard Deviation 5074.7709
4647.090 ng/mL
Standard Deviation 6289.5788
Plasma Concentration at Each Planned Nominal Time-point (Cn)
Time Post-Dose - 20 min
18776.528 ng/mL
Standard Deviation 13893.1674
11491.148 ng/mL
Standard Deviation 10579.5320
18346.910 ng/mL
Standard Deviation 12216.1356
11489.917 ng/mL
Standard Deviation 8402.4627
Plasma Concentration at Each Planned Nominal Time-point (Cn)
Time Post-Dose - 30 min
27860.671 ng/mL
Standard Deviation 12228.9507
16171.896 ng/mL
Standard Deviation 10459.1021
27557.463 ng/mL
Standard Deviation 10049.7928
17619.547 ng/mL
Standard Deviation 10451.6496
Plasma Concentration at Each Planned Nominal Time-point (Cn)
Time Post-Dose - 40 min
31484.356 ng/mL
Standard Deviation 7963.3886
20109.864 ng/mL
Standard Deviation 9451.0500
31258.579 ng/mL
Standard Deviation 7630.5525
21794.588 ng/mL
Standard Deviation 10810.9958
Plasma Concentration at Each Planned Nominal Time-point (Cn)
Time Post-Dose - 50 min
32538.663 ng/mL
Standard Deviation 9976.7494
22216.449 ng/mL
Standard Deviation 8667.4972
31026.608 ng/mL
Standard Deviation 6935.4647
23041.910 ng/mL
Standard Deviation 10063.5154
Plasma Concentration at Each Planned Nominal Time-point (Cn)
Time Post-Dose - 60 min
30424.660 ng/mL
Standard Deviation 5407.6867
22645.898 ng/mL
Standard Deviation 7482.6836
28751.529 ng/mL
Standard Deviation 6440.3355
22226.638 ng/mL
Standard Deviation 7893.6789
Plasma Concentration at Each Planned Nominal Time-point (Cn)
Time Post-Dose - 70 min
28817.725 ng/mL
Standard Deviation 4189.7125
22585.564 ng/mL
Standard Deviation 6387.2660
26979.890 ng/mL
Standard Deviation 6495.2967
21619.517 ng/mL
Standard Deviation 6805.8715
Plasma Concentration at Each Planned Nominal Time-point (Cn)
Time Post-Dose - 80 min
27236.542 ng/mL
Standard Deviation 4944.7693
21532.327 ng/mL
Standard Deviation 5367.9576
25528.950 ng/mL
Standard Deviation 6286.8439
21132.032 ng/mL
Standard Deviation 6103.8828
Plasma Concentration at Each Planned Nominal Time-point (Cn)
Time Post-Dose - 90 min
26045.659 ng/mL
Standard Deviation 4445.1832
20697.612 ng/mL
Standard Deviation 4961.1992
24080.631 ng/mL
Standard Deviation 6464.0707
20182.637 ng/mL
Standard Deviation 5379.6131
Plasma Concentration at Each Planned Nominal Time-point (Cn)
Time Post-Dose - 105 min
23391.182 ng/mL
Standard Deviation 4298.8943
19525.222 ng/mL
Standard Deviation 3347.9779
22336.377 ng/mL
Standard Deviation 5049.6930
18500.837 ng/mL
Standard Deviation 4736.1272
Plasma Concentration at Each Planned Nominal Time-point (Cn)
Time Post-Dose - 120 min
20702.122 ng/mL
Standard Deviation 4461.6587
18414.660 ng/mL
Standard Deviation 3038.3137
20053.854 ng/mL
Standard Deviation 4561.3611
17112.477 ng/mL
Standard Deviation 4579.0063
Plasma Concentration at Each Planned Nominal Time-point (Cn)
Time Post-Dose - 180 min
14091.791 ng/mL
Standard Deviation 3856.4139
13597.701 ng/mL
Standard Deviation 3653.1273
13062.561 ng/mL
Standard Deviation 3345.8475
12893.527 ng/mL
Standard Deviation 3436.8623
Plasma Concentration at Each Planned Nominal Time-point (Cn)
Time Post-Dose - 240 min
9649.611 ng/mL
Standard Deviation 2767.9584
10997.109 ng/mL
Standard Deviation 3518.9434
9483.481 ng/mL
Standard Deviation 3427.9947
9895.761 ng/mL
Standard Deviation 3586.4589
Plasma Concentration at Each Planned Nominal Time-point (Cn)
Time Post-Dose - 360 min
3992.230 ng/mL
Standard Deviation 1611.5462
5390.090 ng/mL
Standard Deviation 2071.2073
3830.211 ng/mL
Standard Deviation 1667.1184
5612.610 ng/mL
Standard Deviation 4105.1920
Plasma Concentration at Each Planned Nominal Time-point (Cn)
Time Post-Dose - 480 min
1942.286 ng/mL
Standard Deviation 948.4031
2839.215 ng/mL
Standard Deviation 1352.4747
1930.929 ng/mL
Standard Deviation 1069.7491
2650.093 ng/mL
Standard Deviation 1697.3457
Plasma Concentration at Each Planned Nominal Time-point (Cn)
Time Post-Dose - 720 min
560.199 ng/mL
Standard Deviation 343.2360
829.589 ng/mL
Standard Deviation 460.9511
544.660 ng/mL
Standard Deviation 417.5077
788.223 ng/mL
Standard Deviation 646.7288

SECONDARY outcome

Timeframe: Up to follow-up day 7

Population: Safety population

Intensity was determined by the Investigator. For symptomatic AEs the following definitions were applied. Mild = 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. Relationship to Investigational Medicinal Products (IMP) 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 AE was caused by IMP. Unlikely = Slight, but remote, chance that AE was caused by IMP. Possible = Reasonable suspicion that the AE was caused by IMP. Probable = Most likely that AE was caused by IMP. Certain = AE was definitely caused by IMP.

Outcome measures

Outcome measures
Measure
Treatment B: Nurofen for Children® 400 mg/20 mL (Fasted)
n=27 Participants
Nurofen for Children® suspension 400 mg/20 mL single-oral dose under fasted condition.
Treatment A: Nurofen for Children® 400 mg/20 mL (Fed)
n=28 Participants
Nurofen for Children® suspension 400 mg/20 mL single-oral dose under fed condition.
Treatment D: Algifor Dolo Junior® 400 mg/20 mL (Fasted)
n=27 Participants
Algifor Dolo Junior® suspension 400 mg/20 mL single-oral dose under fasted condition.
Treatment C: Algifor Dolo Junior® 400 mg/20 mL (Fed)
n=26 Participants
Algifor Dolo Junior® suspension 400 mg/20 mL single-oral dose under fed condition.
Number of Subjects With Adverse Events (AEs).
Relationship to IMP - Certain
0 Participants
0 Participants
0 Participants
0 Participants
Number of Subjects With Adverse Events (AEs).
Treatment Emergent Adverse Event (TEAE)
3 Participants
4 Participants
7 Participants
3 Participants
Number of Subjects With Adverse Events (AEs).
Serious TEAE
0 Participants
0 Participants
0 Participants
0 Participants
Number of Subjects With Adverse Events (AEs).
TEAE Leading to Withdrawal
0 Participants
1 Participants
1 Participants
0 Participants
Number of Subjects With Adverse Events (AEs).
Intensity - Mild
3 Participants
2 Participants
6 Participants
2 Participants
Number of Subjects With Adverse Events (AEs).
Intensity - Moderate
0 Participants
2 Participants
0 Participants
1 Participants
Number of Subjects With Adverse Events (AEs).
Intensity - Severe
0 Participants
0 Participants
1 Participants
0 Participants
Number of Subjects With Adverse Events (AEs).
Relationship to IMP - Probable
0 Participants
0 Participants
0 Participants
0 Participants
Number of Subjects With Adverse Events (AEs).
Relationship to IMP - Possible
0 Participants
1 Participants
0 Participants
1 Participants
Number of Subjects With Adverse Events (AEs).
Relationship to IMP - Unlikely
1 Participants
2 Participants
2 Participants
1 Participants
Number of Subjects With Adverse Events (AEs).
Relationship to IMP - Unrelated
2 Participants
1 Participants
5 Participants
1 Participants
Number of Subjects With Adverse Events (AEs).
Relationship to IMP - Conditional/Unclassified
0 Participants
0 Participants
0 Participants
0 Participants
Number of Subjects With Adverse Events (AEs).
Relationship to IMP - Unassessable /Unclassifiable
0 Participants
0 Participants
0 Participants
0 Participants

Adverse Events

Overall Study

Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
Overall Study
n=28 participants at risk
Nurofen for Children® suspension 400 mg/20 mL single-oral dose under fasted and fed conditions. Algifor Dolo Junior® suspension 400 mg/20 mL single-oral dose under fasted and fed conditions.
Gastrointestinal disorders
Abdominal pain
3.6%
1/28 • Number of events 1 • Up to follow-up day 7
Gastrointestinal disorders
Diarrhoea
3.6%
1/28 • Number of events 1 • Up to follow-up day 7
General disorders
Fatigue
10.7%
3/28 • Number of events 3 • Up to follow-up day 7
General disorders
Feeling cold
3.6%
1/28 • Number of events 1 • Up to follow-up day 7
Gastrointestinal disorders
Peripheral swelling
7.1%
2/28 • Number of events 2 • Up to follow-up day 7
Immune system disorders
Seasonal allergy
3.6%
1/28 • Number of events 1 • Up to follow-up day 7
Infections and infestations
Gastroenteritis
3.6%
1/28 • Number of events 1 • Up to follow-up day 7
Injury, poisoning and procedural complications
Foot fracture
3.6%
1/28 • Number of events 1 • Up to follow-up day 7
Musculoskeletal and connective tissue disorders
Back pain
3.6%
1/28 • Number of events 2 • Up to follow-up day 7
Nervous system disorders
Dizziness
3.6%
1/28 • Number of events 1 • Up to follow-up day 7
Nervous system disorders
Headache
21.4%
6/28 • Number of events 6 • Up to follow-up day 7
Nervous system disorders
Presyncope
3.6%
1/28 • Number of events 1 • Up to follow-up day 7
Nervous system disorders
Somnolence
3.6%
1/28 • Number of events 1 • Up to follow-up day 7
Skin and subcutaneous tissue disorders
Erythema
3.6%
1/28 • Number of events 2 • Up to follow-up day 7

Additional Information

Clinical Research Director

Reckitt Benckiser Healthcare (UK) Ltd.

Phone: +441482 326151

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place