Ibuprofen Suspension Bioequivalence Study | NCT02503085

NCT02503085

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

ID	Type	Description	Link
2013-003366-14	EudraCT Number

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Nurofen for Children® (fasted)	Experimental	Nurofen for Children® suspension 400 mg/20 mL single-oral dose under fasted condition	Drug: Nurofen for Children®
Nurofen for Children® (fed)	Experimental	Nurofen for Children® suspension 400 mg/20 mL single-oral dose under fed condition	Drug: Nurofen for Children®
Algifor Dolo Junior® (fasted)	Active Comparator	Algifor Dolo Junior® suspension 400 mg/20 mL single-oral dose under fasted condition	Drug: Algifor Dolo Junior®
Algifor Dolo Junior® (fed)	Active Comparator	Algifor Dolo Junior® suspension 400 mg/20 mL single-oral dose under fed condition	Drug: Algifor Dolo Junior®

Name	Type	Description	Arm Group Labels	Other Names
Nurofen for Children®	Drug		Nurofen for Children® (fasted) Nurofen for Children® (fed)	Ibuprofen orange oral suspension

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Maximum Plasma Concentration (Cmax)		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)
Area Under the Plasma Concentration-time Curve From Administration to the Last Quantifiable Concentration at Time t (AUC0-t)		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)

Secondary Outcomes

Measure	Description	Time Frame
Elimination Rate Constant (Kel)		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)
AUC From Administration to Infinity (AUC0-inf)	AUC0-inf = AUC0-t + (Ct/Kel), where Ct was the last quantifiable concentration at time t.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects who have given written informed consent.
Age: ≥18 years ≤50 years.
Sex: Male or female subjects are eligible for entry.
Female subject of child bearing potential with a negative pregnancy test at the screening visit and willing to use an effective method of contraception,
Female subject of non-child bearing potential with negative pregnancy test at the screening visit
Male subject willing to use an effective method of contraception, unless anatomically sterile
Status: Healthy subjects as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening.
Healthy Subjects with a Body Mass Index (BMI) of ≥20 and ≤27 kg/m2

Exclusion Criteria:

Pregnancy or lactating female subjects.
A history of significant disease of any body system.
Any condition that may currently interfere with the absorption, distribution, metabolism or excretion of drugs.
A history of allergy or intolerance related to treatment with ibuprofen, aspirin or other Non-Steroidal Anti-inflammatory Drug,or the excipients of the formulations.
A history of or active peptic or duodenal ulcers or gastro-intestinal bleed or upper gastro-intestinal bleed, or other significant gastro-intestinal disorders.
A history of frequent dyspepsia, e.g. heartburn or indigestion.
A history of migraine.
Current smokers and ex-smokers who have smoked within 6 months.
A history of drug abuse (including alcohol).
High consumption of stimulating drinks (caffeine intake per day above 300 mg).
Those with positive drugs of abuse screen including alcohol on any occasion throughout the study.
Ingestion of a prescribed drug at any time in the 14 days before dosing with study medication (excluding hormonal contraceptives and hormone replacement therapy), or consumption of enzyme inhibitors or inducers during the previous month (such as barbiturates, carbamazepine, erythromycin, phenytoin, etc.).
Ingestion of an over-the-counter preparation within 7 days before dosing with study medication.
Donation of blood in quantity in the previous 12 weeks before enrolment into the study.
Known human immune deficiency virus (HIV) positive status, or a positive viral serology screen.
Topical use of ibuprofen within 7 days before dosing with study medication.
Those previously randomised into this study.
Employee at study site.
Partner or first degree relative of the Investigator.
Those who have participated in a clinical trial in the previous 12 weeks.
Those unable in the opinion of the Investigator to comply fully with the study requirements.

Arm/Group Information

ID	Title	Description
FG000	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.
FG001	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.
FG002	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.
FG003	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.

Periods

Title

Milestones

Reasons Not Completed

Period 1

Type	Comment	Milestone Data
STARTED		FG0007 subjects FG0017 subjects FG0027 subjects FG0037 subjects
COMPLETED		FG0007 subjects FG0017 subjects FG0027 subjects FG0037 subjects
NOT COMPLETED		FG0000 subjects FG0010 subjects FG0020 subjects FG0030 subjects

Period 1: Washout (3 to 7 Days)

Type	Comment	Milestone Data
STARTED		FG0007 subjects FG0017 subjects FG0027 subjects FG003

Period 2

Type	Comment	Milestone Data
STARTED		FG0007 subjects FG0017 subjects FG0027 subjects FG003

Period 2: Washout (3 to 7 Days)

Type	Comment	Milestone Data
STARTED		FG0007 subjects FG0017 subjects FG0027 subjects FG003

Period 3

Type	Comment	Milestone Data
STARTED		FG0006 subjects FG0017 subjects FG0026 subjects FG003

Period 3: Washout (3 to 7 Days)

Type	Comment	Milestone Data
STARTED		FG0006 subjects FG0017 subjects FG0026 subjects FG003

Period 4

Type	Comment	Milestone Data
STARTED		FG0006 subjects FG0017 subjects FG0026 subjects FG003

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	Overall Study	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.

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous			Mean

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Maximum Plasma Concentration (Cmax)

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.

Posted

Mean

Standard Deviation

ng/mL

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)

ID	Title	Description
OG000	Treatment B: Nurofen for Children® 400 mg/20 mL (Fasted)	Nurofen for Children® suspension 400 mg/20 mL single-oral dose under fasted condition.
OG001	Treatment A: Nurofen for Children® 400 mg/20 mL (Fed)	Nurofen for Children® suspension 400 mg/20 mL single-oral dose under fed condition.

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Overall Study	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.