Ibuprofen Suspension Bioequivalence Study

NCT ID: NCT02503085

Last Updated: 2018-04-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-02
• Study Completion Date: 2015-08-25

Brief Summary

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

Conditions

Healthy Volunteer Study

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Nurofen for Children® (fasted)

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

Group Type: EXPERIMENTAL

Nurofen for Children®

Intervention Type: DRUG

Nurofen for Children® (fed)

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

Group Type: EXPERIMENTAL

Nurofen for Children®

Intervention Type: DRUG

Algifor Dolo Junior® (fasted)

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

Group Type: ACTIVE_COMPARATOR

Algifor Dolo Junior®

Intervention Type: DRUG

Algifor Dolo Junior® (fed)

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

Group Type: ACTIVE_COMPARATOR

Algifor Dolo Junior®

Intervention Type: DRUG

Interventions

Nurofen for Children®

Intervention Type: DRUG

Algifor Dolo Junior®

Intervention Type: DRUG

Other Intervention Names

Ibuprofen orange oral suspension; Ibuprofen oral suspension

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Reckitt Benckiser Healthcare (UK) Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Reckit Benckiser

Hull, , United Kingdom

Countries

United Kingdom

Other Identifiers

2013-003366-14

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

NL1304

Identifier Type: -

Identifier Source: org_study_id