Ibuprofen Suspension Bioequivalence Study

Reckitt Benckiser

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteer Study

Treatments: Drug: Nurofen for Children®; Drug: Algifor Dolo Junior®

Study type: Interventional

Funder types: Industry

Identifiers

NCT02503085

NL1304

2013-003366-14 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 28 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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28 participants in 4 patient groups

Nurofen for Children® (fasted)

Experimental group

Description:

Nurofen for Children® suspension 400 mg/20 mL single-oral dose under fasted condition

Treatment:

Drug: Nurofen for Children®

Nurofen for Children® (fed)

Experimental group

Description:

Nurofen for Children® suspension 400 mg/20 mL single-oral dose under fed condition

Treatment:

Drug: Nurofen for Children®

Algifor Dolo Junior® (fasted)

Active Comparator group

Description:

Algifor Dolo Junior® suspension 400 mg/20 mL single-oral dose under fasted condition

Treatment:

Drug: Algifor Dolo Junior®

Algifor Dolo Junior® (fed)

Active Comparator group

Description:

Algifor Dolo Junior® suspension 400 mg/20 mL single-oral dose under fed condition

Treatment:

Drug: Algifor Dolo Junior®