Clinical trial NCT02503085: Ibuprofen Suspension Bioequivalence Study
Official title: A Randomized, Single-dose, 4-way Crossover, Open-label, Pharmacokinetic (PK) Study Comparing a 2% (w/v) Suspension of Ibuprofen (400 mg/20 mL Nurofen for Children®) With a Swiss Reference 2% (w/v) Suspension of Ibuprofen (400 mg/20 mL Algifor Dolo Junior®) in the Fed and Fasted States
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer Study
Keywords: Ibuprofen
Lead sponsor: Reckitt Benckiser Healthcare (UK) Limited
Sponsor class: INDUSTRY
First posted: 2015-07-20
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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


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.

Primary outcomes:
measure: Maximum Plasma Concentration (Cmax)
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)
measure: Area Under the Plasma Concentration-time Curve From Administration to the Last Quantifiable Concentration at Time t (AUC0-t)
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)
Secondary outcomes:
measure: Elimination Rate Constant (Kel)
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)
measure: AUC From Administration to Infinity (AUC0-inf)
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)
measure: Ratio of AUC0-t/AUC0-inf (AUCR)
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)
measure: Time to Cmax (Tmax)
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)
measure: Plasma Concentration Half-life (T1/2)
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)
measure: Plasma Concentration at Each Planned Nominal Time-point (Cn)
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)
measure: Number of Subjects With Adverse Events (AEs).
timeFrame: Up to follow-up day 7
Other outcomes:
Locations:
city: Hull
country: United Kingdom
facility: Reckit Benckiser
Study officials:
References: