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    Summary
    EudraCT Number:2013-001442-34
    Sponsor's Protocol Code Number:IBUPAI0002
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-06-07
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSweden - MPA
    A.2EudraCT number2013-001442-34
    A.3Full title of the trial
    A SINGLE-DOSE, RANDOMIZED, TWO-PERIOD, CROSSOVER STUDY TO ASSESS BIOEQUIVALENCE BETWEEN TWO IBUPROFEN 200 MG TABLET FORMULATIONS, IN HEALTHY ADULTS.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A SINGLE-DOSE, RANDOMIZED, TWO-PERIOD, CROSSOVER STUDY TO ASSESS BIOEQUIVALENCE BETWEEN TWO IBUPROFEN 200 MG TABLET FORMULATIONS, IN HEALTHY ADULTS.
    A.4.1Sponsor's protocol code numberIBUPAI0002
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorMcNeil AB
    B.1.3.4CountrySweden
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportMcNeil AB
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMcNeil AB
    B.5.2Functional name of contact pointIngrid Ademar
    B.5.3 Address:
    B.5.3.1Street AddressNorrbroplatse 2 / PO Box 941
    B.5.3.2Town/ cityHelsingborg
    B.5.3.3Post code25109
    B.5.3.4CountrySweden
    B.5.4Telephone number4642288734
    B.5.5Fax number4642288130
    B.5.6E-mailiademar@its.jnj.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Ipren, 200 mg film-coated tablet
    D.2.1.1.2Name of the Marketing Authorisation holderMcNeil Sweden AB
    D.2.1.2Country which granted the Marketing AuthorisationSweden
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameIpren
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNIBUPROFEN
    D.3.9.1CAS number 15687-27-1
    D.3.9.4EV Substance CodeSUB08098MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Brufen, 200 mg film-coated tablet
    D.2.1.1.2Name of the Marketing Authorisation holderAbott Scandinavia AB
    D.2.1.2Country which granted the Marketing AuthorisationSweden
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameBrufen
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNIBUPROFEN
    D.3.9.1CAS number 15687-27-1
    D.3.9.4EV Substance CodeSUB08098MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Pain
    E.1.1.1Medical condition in easily understood language
    Pain
    E.1.1.2Therapeutic area Diseases [C] - Symptoms and general pathology [C23]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to show bioequivalence between Ipren film coated tablet 200 mg and Brufen film coated tablet 200 mg, with respect to the single-dose pharmacokinetics of S-(+) ibuprofen. The maximum observed plasma concentrations (Cmax), and the areas under the concentration-vs.-time curve until last measurable concentration (AUCt), will be compared to assess bioequivalence.
    E.2.2Secondary objectives of the trial
    • to compare the area under the concentration-vs.-time curve extrapolated to infinity (AUC∞) of S-(+) ibuprofen, between treatments,
    • to compare Cmax, AUCt and AUC∞ of R-(-) and total ibuprofen, respectively, between treatments,
    • to further describe the pharmacokinetics of R-(-), S-(+) and total ibuprofen, respectively, of the investigational products with respect to:
    o the time at which the maximum concentration is observed (tmax),
    o the terminal elimination rate constant (λz),
    o the terminal half-life (t1/2),
    o the mean residence time (MRT),
    o the extrapolated part of AUC∞ (AUCExtra)
    • to evaluate the tolerability of the investigational products based on reported and observed Adverse Events (AEs).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Healthy male or female volunteers subjects between the ages of 18 and 50 years, inclusive. Health is defined as the absence of clinically relevant abnormalities as judged by the investigator, based on a detailed medical history, a physical examination, including blood pressure and pulse rate measurements, 12-lead electrocardiogram, as well as clinical laboratory tests. The responsible investigator may request additional investigations or analyses if necessary.
    2. Non- or ex-tobacco user, being defined as someone who completely stopped smoking or using any form of tobacco or nicotine for at least 12 months before screening visit of this study.
    3. For females: Postmenopausal state (absence of menstrual discharge for at least two years and a follicle stimulating hormone (FSH) serum level exceeding 30 IU/L) or premenopausal/perimenopausal state with an effective means of contraception (oral, injected, implanted, transdermal, hormonal contraceptives, vaginal contraceptive ring, intrauterine device, or status after operative sterilization), single male partner who has had a vasectomy, or declared absence of sexual contact, with a male partner, during the study.
    Males: No pregnant spouse or partner at screening and willingness to protect potential spouse or partner from becoming pregnant during the study.
    4. Body Mass Index (BMI) ≥ 18.5 and ≤ 30.0 kg/m2.
    5. A personally signed and dated informed consent document, indicating that the subject has been informed of all pertinent aspects of the study.
    6. Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures specified in the protocol.
    E.4Principal exclusion criteria
    1. Use of medications other than contraceptives or occasional use of paracetamol or NSAIDs.
    2. Use of NSAIDs (or any other product containing NSAIDs) within 7 days before the first treatment visit and throughout the study.
    3. History of significant allergy or hypersensivity (e.g. asthma, angioedema) to ibuprofen, ASA, other NSAIDs or any related products (including excipients of the formulations).
    4. Females: Pregnancy and/or breast-feeding.
    5. History of peptic ulcer or gastrointestinal bleeding.
    6. Treatment with an investigational drug within 3 months preceding the first dose of study treatment.
    7. Preplanned surgical procedures during the study period, if this may interfere with the conduct of the study.
    8. History of regular alcohol consumption in the 6 months before screening, exceeding weekly limits of 2 L of wine or 5 L of beer or 0.6 L of spirits for females, and 3 L of wine or 7.5 L of beer or 0.9 L of spirits for males. The investigator may lower these limits if a subject consumes different types of alcoholic beverages.
    9. Donation or loss of blood within 3 months prior to the first treatment visit if the estimated lost blood volume equaled or exceeded 450 mL.
    10. Relationship to persons involved directly in the conduct of the study (i.e., principal investigator, sub-investigators, study coordinators, other study personnel, employees or contractors of the sponsor or Johnson & Johnson subsidiaries, and the family of each).
    E.5 End points
    E.5.1Primary end point(s)
    The primary study endpoints are the Cmax and AUCt of S-(+) ibuprofen.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Pre-dose and at 15, 30, 40, 50, 60, 70, 80, 90, and 105 minutes as well as at 2, 2.5, 3, 4, 5, 6, 7, 9, and 12 hours after study drug administration.
    E.5.2Secondary end point(s)
    Secondary study endpoints are:
    • Cmax and AUCt of R-(-) and total ibuprofen, respectively,
    • AUC∞, tmax, λz, t1/2, AUCExtra and MRT of R-(-), S-(+) and total ibuprofen, respectively,
    • the occurrence of Adverse Events (AEs).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Pre-dose and at 15, 30, 40, 50, 60, 70, 80, 90, and 105 minutes as well as at 2, 2.5, 3, 4, 5, 6, 7, 9, and 12 hours after study drug administration.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy No
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence Yes
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over Yes
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 30
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients No
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state30
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2013-07-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-08-06
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-09-24
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