Ibuprofen Suspension Bioequivalence Study

Phase 1

Completed

Conditions: Healthy Volunteer Study

Interventions: Drug: Algifor Dolo Junior®
Drug: Nurofen for Children®

Registration Number: NCT02503085

Lead Sponsor: Reckitt Benckiser Healthcare (UK) Limited

Brief Summary: The purpose of this study was to determine the rate and extent of absorption of Ibuprofen suspension formulations.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 28

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Algifor Dolo Junior® (fed)	Algifor Dolo Junior®	Algifor Dolo Junior® suspension 400 mg/20 mL single-oral dose under fed condition
Nurofen for Children® (fed)	Nurofen for Children®	Nurofen for Children® suspension 400 mg/20 mL single-oral dose under fed condition
Algifor Dolo Junior® (fasted)	Algifor Dolo Junior®	Algifor Dolo Junior® suspension 400 mg/20 mL single-oral dose under fasted condition
Nurofen for Children® (fasted)	Nurofen for Children®	Nurofen for Children® suspension 400 mg/20 mL single-oral dose under fasted condition

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)
Time to Cmax (Tmax)	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)
Plasma Concentration at Each Planned Nominal Time-point (Cn)	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)	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.
Number of Subjects With Adverse Events (AEs).	Up to follow-up day 7	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.
AUC From Administration to Infinity (AUC0-inf)	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)	AUC0-inf = AUC0-t + (Ct/Kel), where Ct was the last quantifiable concentration at time t.
Ratio of AUC0-t/AUC0-inf (AUCR)	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)
Plasma Concentration Half-life (T1/2)	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)	Terminal elimination half-life (T1/2) = ln(2)/Kel