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    Summary
    EudraCT Number:2016-001439-11
    Sponsor's Protocol Code Number:DDD16BICARBONATE
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-05-23
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2016-001439-11
    A.3Full title of the trial
    Influence of bicarbonate on drug gastrointestinal behaviour and disposition
    Invloed van bicarbonaat op het gastrointestinaal gedrag en de dispositie van een geneesmiddel
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The infuence of bicarbonate on the behaviour of a drug in the stomach and small intestine and its implications for drug exposure.
    De invloed van bicarbonaat op het gedrag van een geneesmiddel in de maag en darm en blootstelling aan dit geneesmiddel.
    A.4.1Sponsor's protocol code numberDDD16BICARBONATE
    A.5.4Other Identifiers
    Name:Clinical Trial Center UZ Leuven identifierNumber:S59214
    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 SponsorKU Leuven - Drug Delivery and Disposition
    B.1.3.4CountryBelgium
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportKU Leuven
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationKU Leuven
    B.5.2Functional name of contact pointDrug Delivery and Disposition
    B.5.3 Address:
    B.5.3.1Street AddressGasthuisberg O&N 2 - Herestraat 49 bus 921
    B.5.3.2Town/ cityLeuven
    B.5.3.3Post code3000
    B.5.3.4CountryBelgium
    B.5.4Telephone number+3216379105
    B.5.6E-mailjens.vandenabeele@kuleuven.be
    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 DAFALGAN 500 mg tabletten
    D.2.1.1.2Name of the Marketing Authorisation holderBristol-Myers Squibb Belgium N.V.
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    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 nameDafalgan
    D.3.4Pharmaceutical form 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 INNAcetaminophen
    D.3.9.1CAS number 103-90-2
    D.3.9.3Other descriptive namePARACETAMOL
    D.3.9.4EV Substance CodeSUB09611MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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
    Healthy human volunteers
    (administration of an antipyretic, analgetic drug)
    Gezonde vrijwillgers
    (toediening van een analgetisch, antipyretisch geneesmiddel
    E.1.1.1Medical condition in easily understood language
    Healthy human volunteers
    Gezonde vrijwilligers
    E.1.1.2Therapeutic area Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]
    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
    To evaluate the influence of bicarbonate on gastric motility by administering bicarbonate-containing beverages or plain water.
    Deze studie heeft tot doel de invloed van bicarbonaat op maagmotiliteit te bestuderen door middel van het toedienen van bicarbonaatbevattende dranken of gewoon water.
    E.2.2Secondary objectives of the trial
    To evaluate the influence of possible changes to gastric motility, induced by bicarbonate administration, on gastrointestinal behaviour of an orally administered drug (Dafalgan).

    To evaluate the influence of possible changes to gastric motility, induced by bicarbonate administration, on systemic exposure (pharmacokinetics) to an orally administered drug (Dafalgan).
    - Bestuderen van de invloed van mogelijke veranderingen in maagmotiliteit geïnduceerd door bicarbonaat op het gastrointestinale gedrag van een oraal toegediend geneesmiddel.

    - Bestuderen van de invloed van mogelijke veranderingen in maagmotiliteit geïnduceerd door bicarbonaat op de systemische blootstelling aan een oraal toegediend geneesmiddel.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - healthy volunteers
    - age: 18 - 35 years old
    • gezonde vrijwilligers
    • leeftijd: 18-35 jaar
    E.4Principal exclusion criteria
    - disease
    - acute/chronic GI condition
    - use of medication
    - pregnancy
    - frequent exposure to X-rays during the past year
    - HIV / HBV / HCV infection
    - ziekte
    - acute/chronische maagdarmstoornis
    - geneesmiddelengebruik
    - (mogelijke) zwangerschap
    - frequente blootstelling aan röntgenstralen gedurende het voorbije
    jaar
    - HIV, HBV of HCV besmetting
    E.5 End points
    E.5.1Primary end point(s)
    not applicable
    niet van toepassing
    E.5.1.1Timepoint(s) of evaluation of this end point
    not applicable
    niet van toepassing
    E.5.2Secondary end point(s)
    not applicable
    niet van toepassing
    E.5.2.1Timepoint(s) of evaluation of this end point
    not applicable
    niet van toepassing
    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 No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    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 No
    E.8.1.2Open No
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Compare the influence of bicarbonate-containing drinks and contractility phase on drug disposition
    E.8.2.4Number of treatment arms in the trial8
    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
    last visit of last subject
    laatste bezoek van laatste vrijwilliger
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    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: 10
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state10
    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 Decision2016-06-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-06-17
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-12-22
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