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Ibuprofen and Paracetamol Pharmacokinetic Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02452450
Recruitment Status : Completed
First Posted : May 22, 2015
Last Update Posted : May 27, 2015
Simbec Research
Information provided by (Responsible Party):
Reckitt Benckiser Healthcare (UK) Limited

Brief Summary:
The purpose of this study was to determine rates of absorption of Ibuprofen and Paracetamol formulations.

Condition or disease Intervention/treatment Phase
Healthy Volunteer Study Drug: Ibuprofen Acid Drug: Ibuprofen Lysine Drug: Ibuprofen Sodium Drug: Ibuprofen Liquid Capsules Drug: Paracetamol Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Study Start Date : January 2014
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Ibuprofen lysine Drug: Ibuprofen Lysine
Experimental: Ibuprofen sodium Drug: Ibuprofen Sodium
Experimental: Ibuprofen liquid capsules Drug: Ibuprofen Liquid Capsules
Active Comparator: Ibuprofen acid Drug: Ibuprofen Acid
Active Comparator: Paracetamol Drug: Paracetamol

Primary Outcome Measures :
  1. Time to the maximum concentration (Cmax) of the reference Ibuprofen [ Time Frame: 0-4hr ]
  2. Time to the first extrapolated non-zero concentration (Tlag) [ Time Frame: 0-4hr ]
  3. Time to the maximum concentration (Tmax) [ Time Frame: 0-4hr ]

Secondary Outcome Measures :
  1. Time to the lower therapeutic level reaching at least 5 µg/ml (T5.0) for ibuprofen and paracetamol [ Time Frame: 0-4hr ]
  2. Time to the mid therapeutic level reaching at least 8.4 µg/ml (T8.4) for ibuprofen and 10 µg/ml (T10.0) for paracetamol [ Time Frame: 0-4hr ]
  3. Time to the higher therapeutic level reaching at least 10.0 µg/ml (T10.0) for ibuprofen and 20 µg/ml (T20.0) for paracetamol [ Time Frame: 0-4hr ]
  4. Partial area under the curve (AUCs) at each nominal blood sampling time-point [ Time Frame: 0-4hr ]
  5. The area under the curve up to the median Tmax for the ibuprofen reference product (AUCTmaxRef) [ Time Frame: 0-4hr ]
  6. The plasma concentration at each planned nominal time-point (Cn) [ Time Frame: 0-4hr ]
  7. The maximum plasma concentration (Cmax) [ Time Frame: 0-4hr ]

Information from the National Library of Medicine

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

Inclusion Criteria:

  1. Age: > 18 to < 50 years.
  2. Sex: Male and female subjects are eligible for entry.
  3. Female subject of child bearing potential with a negative pregnancy test at the screening visit and willing to use an effective method of contraception, if applicable
  4. Female subject of non-child bearing potential with negative pregnancy test at the screening visit.
  5. Male subject willing to use an effective method of contraception.
  6. Status: Healthy volunteers with a body mass index of >18 and <30 kg/m2.
  7. Absence of relevant abnormalities in the clinical examination, ECG, drug and safety analysis.
  8. Subjects who have given written informed consent

Exclusion Criteria:

  1. Pregnant or lactating female subjects.
  2. A history of significant disease of any body-system.
  3. Any condition that may currently interfere with the absorption, distribution, metabolism or excretion of drugs.
  4. A history of allergy or intolerance (including angio-oedema, urticaria, bronchospasm and rhinitis) related to treatment with ibuprofen, aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs), paracetamol, or the excipients of the formulations.
  5. A history of peptic or duodenal ulcers or gastro-intestinal bleed or upper gastro-intestinal bleed, or other significant gastro-intestinal disorders.
  6. A history of frequent dyspepsia, e.g., heartburn or indigestion.
  7. A history of migraine.
  8. A history of psychotic illness, attempted suicide or parasuicide.
  9. Current smokers and ex-smokers who have smoked within 6 months.
  10. A history of drug abuse (including alcohol).
  11. High consumption of stimulating drinks
  12. Those with positive drugs of abuse screen including alcohol on any occasion throughout the study.
  13. 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).
  14. Ingestion of an over-the-counter preparation within 7 days before dosing with study medication, including herbal medications, vitamin/fish oil supplements, ibuprofen and other NSAIDs and paracetamol.
  15. Donation of blood in quantity in the previous 12 weeks before enrolment into the study
  16. Known human immune deficiency virus (HIV) positive status, or a positive viral serology screen.
  17. Topical use of ibuprofen within 7 days before dosing with study medication
  18. Those previously randomised into this study.
  19. Employee at study site.
  20. Partner or first degree relative of the investigator.
  21. Those with an ibuprofen level > 10 ng/ml as determined at pre-study screening visit 2 (Part 2 (Pivotal Phase) of the study only).
  22. Those who are unwilling to consume gelatin of animal origin (Part 2 (Pivotal Phase) of the study only).
  23. Those who have participated in a clinical trial in the previous 12 weeks
  24. Those unable in the opinion of the Investigator to comply fully with the study requirements.

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Reckitt Benckiser Healthcare (UK) Limited Identifier: NCT02452450    
Other Study ID Numbers: NL1307
First Posted: May 22, 2015    Key Record Dates
Last Update Posted: May 27, 2015
Last Verified: May 2015
Additional relevant MeSH terms:
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Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
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