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Study to Investigate the Relative Bioavailability of Ibuprofen in Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT02183012
Recruitment Status : Completed
First Posted : July 8, 2014
Last Update Posted : July 8, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
  • Study to demonstrate average bioequivalence between a 400 mg ibuprofen extrudate tablet (Test) and a 400 mg ibuprofen lysinate tablet (Dolormin extra ®; reference 1) under fasted conditions.
  • Study to determine the relative bioavailability of ibuprofen following single administration of a 400 mg ibuprofen extrudate tablet (Test) compared to a 400 mg ibuprofen tablet (Brufen® 400mg, Denmark; Reference 2) under fasted conditions.
  • Study to determine the relative bioavailability of ibuprofen following single administration of a 400 mg ibuprofen extrudate tablet (Test) compared to a 400 mg ibuprofen lysinate tablet (Dolormin extra ®; reference 1) or a 400 mg ibuprofen tablet (Brufen® 400mg, Denmark; Reference 2), respectively, under fed conditions.
  • Study to evaluate the effect of food on the pharmacokinetics of ibuprofen for all three formulations.

Condition or disease Intervention/treatment Phase
Healthy Drug: Ibuprofen extrudate Drug: Ibuprofen lysinate Drug: Ibuprofen Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open-label, Randomised, Single Dose, Four-way Crossover Study to Investigate the Relative Bioavailability of a 400 mg Ibuprofen Extrudate Tablet Compared to a 400 mg Ibuprofen Lysinate Tablet (Dolormin Extra®) and a 400 mg Ibuprofen Tablet (Brufen® 400 mg, Denmark) in Fasted Condition and After Ingestion of a Standardised Meal in Healthy Male and Female Volunteers.
Study Start Date : August 2002
Actual Primary Completion Date : October 2002

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: A: Ibuprofen extrudate, fed state Drug: Ibuprofen extrudate
Experimental: B: Ibuprofen extrudate, fasted state Drug: Ibuprofen extrudate
Active Comparator: C: Ibuprofen lysinate tablet, fed state Drug: Ibuprofen lysinate
Active Comparator: D: Ibuprofen lysinate tablet, fasted state Drug: Ibuprofen lysinate
Active Comparator: E: Ibuprofen tablet, fed state Drug: Ibuprofen
Active Comparator: F: Ibuprofen tablet, fasted state Drug: Ibuprofen



Primary Outcome Measures :
  1. AUC0-∞ (area under the concentration-time curve of the analyte in plasma from zero time to infinity) [ Time Frame: Pre-dose and 15, 30, 45 min, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24 hours after treatment on day 1 of visits 2-5 ]
  2. Cmax (maximum observed concentration of the analyte in plasma) [ Time Frame: Pre-dose and 15, 30, 45 min, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24 hours after treatment on day 1 of visits 2-5 ]
  3. AUC0-tz (area under the concentration-time curve of the analyte in plasma from zero time to the time of the last quantifiable drug concentration) [ Time Frame: Pre-dose and 15, 30, 45 min, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24 hours after treatment on day 1 of visits 2-5 ]

Secondary Outcome Measures :
  1. Individual time courses of the ibuprofen plasma concentrations [ Time Frame: Pre-dose and 15, 30, 45 min, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24 hours after treatment on day 1 of visits 2-5 ]
  2. AUCtrunc (Area under the concentration-time curve of the analyte in plasma from zero time to median tmax values of the reference formulation) [ Time Frame: Pre-dose and 15, 30, 45 min, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24 hours after treatment on day 1 of visits 2-5 ]
  3. tmax (time to reach Cmax) [ Time Frame: Pre-dose and 15, 30, 45 min, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24 hours after treatment on day 1 of visits 2-5 ]
  4. t1/2 (terminal half-life of the analyte in plasma) [ Time Frame: Pre-dose and 15, 30, 45 min, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24 hours after treatment on day 1 of visits 2-5 ]
  5. λz (terminal rate constant of the analyte in plasma) [ Time Frame: Pre-dose and 15, 30, 45 min, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24 hours after treatment on day 1 of visits 2-5 ]
  6. MRTtot (total mean residence time of the analyte molecules in the body) [ Time Frame: Pre-dose and 15, 30, 45 min, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24 hours after treatment on day 1 of visits 2-5 ]
  7. CL/F (total clearance of the analyte in plasma following extravascular administration) [ Time Frame: Pre-dose and 15, 30, 45 min, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24 hours after treatment on day 1 of visits 2-5 ]
  8. Vz/F (apparent volume of distribution during the terminal phase λz following extravascular administration) [ Time Frame: Pre-dose and 15, 30, 45 min, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24 hours after treatment on day 1 of visits 2-5 ]
  9. Number of patients with adverse events [ Time Frame: up to 24 days ]
  10. Number of patients with abnormal changes in laboratory parameters [ Time Frame: up to 8 days following last drug administration ]
  11. Number of patients with clinically significant changes in vital signs (blood pressure (BP), pulse rate (PR)) [ Time Frame: up to 8 days following last drug administration ]
  12. Number of patients with abnormal changes in 12-lead electrocardiogram (ECG) [ Time Frame: up to 8 days following last drug administration ]
  13. Number of patients with abnormal findings in physical examination [ Time Frame: up to 8 days following last drug administration ]
  14. Assessment of tolerability on a 4-point scale [ Time Frame: up to 8 days following last drug administration ]


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Ages Eligible for Study:   21 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy males and females according to the following criteria:

    • Based upon a complete medical history, including the physical examination, vital signs (BP, PR), 12-lead ECG, clinical laboratory tests:

      • No finding deviating from normal and of clinical relevance
      • No evidence of a clinically relevant concomitant disease.
  • Age ≥ 21 and Age ≤ 50 years
  • BMI ≥ 18.5 and BMI ≤ 29.9 kg/m2 (Body Mass Index)
  • Signed and dated written informed consent prior to admission to the study in accordance with GCP (Good Clinical Practice) and the local legislation

Exclusion Criteria:

  • Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
  • Surgery of gastrointestinal tract (except appendectomy)
  • History of recent surgery including dental surgery
  • History of gastrointestinal ulcer or gastrointestinal inflammation (gastritis, ulcerative colitis, Crohn's disease)
  • Blood dyscrasias of unknown origin
  • Subjects with porphyries diseases
  • Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
  • History of relevant orthostatic hypotension, fainting spells or blackouts
  • Chronic or relevant acute infections
  • History of allergy/hypersensitivity/allergic rhinitis (including drug allergy) which is deemed relevant to he trial as judged by the investigator
  • Intake of drugs with a long half-life (> 24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial except substitution therapy (thyroid, ovaries) and hormonal contraception
  • Use of any drugs, which might influence the results of the trial (within 10 days prior to administration or during the trial)
  • Participation in another trial with an investigational drug (within two months prior to administration or during the trial)
  • Smoker (more than 10 cigarettes or 3 cigars or 3 pipes/day)
  • Inability to refrain from smoking on trial days
  • Alcohol abuse (more than 60 g/day)
  • Drug abuse
  • Blood donation (more than 100 mL within four weeks prior to administration or during the trial)
  • Excessive physical activities (within one week prior to administration or during the trial)
  • Any laboratory value outside the reference range of clinical relevance
  • Inability to comply with dietary regimen of study centre
  • For female subjects:

    • Pregnancy
    • Positive pregnancy test
    • No adequate contraception e.g. oral contraceptives, sterilisation, IUP (intrauterine pessary: in case a IUP was used for contraception, volunteers must be advised to employ additional contraceptive measures (e.g. condom by partner) because prostaglandin inhibition may alter IUP contraceptive efficacy)
    • Inability to maintain this adequate contraception during the whole study period
    • Lactation period

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02183012     History of Changes
Other Study ID Numbers: 1024.5
First Posted: July 8, 2014    Key Record Dates
Last Update Posted: July 8, 2014
Last Verified: July 2014

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