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Ibuprofen Suspension Bioequivalence Study

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ClinicalTrials.gov Identifier: NCT02503085
Recruitment Status : Completed
First Posted : July 20, 2015
Results First Posted : April 13, 2018
Last Update Posted : April 13, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Healthy Volunteer Study Drug: Nurofen for Children® Drug: Algifor Dolo Junior® Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
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
Actual Study Start Date : June 2, 2015
Actual Primary Completion Date : August 25, 2015
Actual Study Completion Date : August 25, 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Nurofen for Children® (fasted)
Nurofen for Children® suspension 400 mg/20 mL single-oral dose under fasted condition
Drug: Nurofen for Children®
Other Name: Ibuprofen orange oral suspension

Experimental: Nurofen for Children® (fed)
Nurofen for Children® suspension 400 mg/20 mL single-oral dose under fed condition
Drug: Nurofen for Children®
Other Name: Ibuprofen orange oral suspension

Active Comparator: Algifor Dolo Junior® (fasted)
Algifor Dolo Junior® suspension 400 mg/20 mL single-oral dose under fasted condition
Drug: Algifor Dolo Junior®
Other Name: Ibuprofen oral suspension

Active Comparator: Algifor Dolo Junior® (fed)
Algifor Dolo Junior® suspension 400 mg/20 mL single-oral dose under fed condition
Drug: Algifor Dolo Junior®
Other Name: Ibuprofen oral suspension




Primary Outcome Measures :
  1. Maximum Plasma Concentration (Cmax) [ Time Frame: 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) ]
  2. Area Under the Plasma Concentration-time Curve From Administration to the Last Quantifiable Concentration at Time t (AUC0-t) [ Time Frame: 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 :
  1. Elimination Rate Constant (Kel) [ Time Frame: 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) ]
  2. AUC From Administration to Infinity (AUC0-inf) [ Time Frame: 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.

  3. Ratio of AUC0-t/AUC0-inf (AUCR) [ Time Frame: 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) ]
  4. Time to Cmax (Tmax) [ Time Frame: 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) ]
  5. Plasma Concentration Half-life (T1/2) [ Time Frame: 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

  6. Plasma Concentration at Each Planned Nominal Time-point (Cn) [ Time Frame: 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.

  7. Number of Subjects With Adverse Events (AEs). [ Time Frame: 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.




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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02503085


Locations
United Kingdom
Reckit Benckiser
Hull, United Kingdom
Sponsors and Collaborators
Reckitt Benckiser Healthcare (UK) Limited

Responsible Party: Reckitt Benckiser Healthcare (UK) Limited
ClinicalTrials.gov Identifier: NCT02503085     History of Changes
Other Study ID Numbers: NL1304
2013-003366-14 ( EudraCT Number )
First Posted: July 20, 2015    Key Record Dates
Results First Posted: April 13, 2018
Last Update Posted: April 13, 2018
Last Verified: April 2018

Keywords provided by Reckitt Benckiser Healthcare (UK) Limited:
Ibuprofen

Additional relevant MeSH terms:
Ibuprofen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action