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    Summary
    EudraCT Number:2012-004065-41
    Sponsor's Protocol Code Number:AML01
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2012-11-19
    Trial 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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2012-004065-41
    A.3Full title of the trial
    Comparative study of pharmacokinetics of amlodipine besilate oral liquid and tablets in healthy Dutch volunteers
    Vergelijkend onderzoek naar de farmacokinetiek van amlodipine besilaat orale drank en tabletten in gezonde Nederlandse vrijwilligers
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Comparison of the pharmacokinetics of amlodipine besilate oral liquid and tablets
    jking van de farmacokinetiek van amlodipine besilaat drank en tabletten
    A.3.2Name or abbreviated title of the trial where available
    Comparison of the pharmacokinetics of amlodipine besilate oral liquid and tablets
    jking van de farmacokinetiek van amlodipine besilaat drank en tabletten
    A.4.1Sponsor's protocol code numberAML01
    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 SponsorErasmus Medical Centre
    B.1.3.4CountryNetherlands
    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 supportZonMW
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationErasmus Medical Centre
    B.5.2Functional name of contact pointL. Hanff
    B.5.3 Address:
    B.5.3.1Street Address's Gravendijkwal 230
    B.5.3.2Town/ cityRotterdam
    B.5.3.3Post code3015 CE
    B.5.3.4CountryNetherlands
    B.5.6E-mailL.Hanff@erasmusmc.nl
    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 No
    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 nameAmlodipine oral liquid 0,5 mg/ml (as besilate)
    D.3.4Pharmaceutical form Oral solution
    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 INNAmlodipine besilate
    D.3.9.1CAS number 111470-99-6
    D.3.9.3Other descriptive nameAMLODIPINE BESILATE
    D.3.9.4EV Substance CodeSUB12864MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.5
    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 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 Norvasc 5
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer BV
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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.3.4Pharmaceutical 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 INNAmlodipine besilate
    D.3.9.1CAS number 111470-99-6
    D.3.9.3Other descriptive nameAMLODIPINE BESILATE
    D.3.9.4EV Substance CodeSUB12864MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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
    Hypertension
    Hypertensie
    E.1.1.1Medical condition in easily understood language
    High blood pressure
    Hoge bloeddruk
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    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 aim of this study is to assess and compare the pharmacokinetic parameters of the newly developed amlodipine besilate oral liquid 0,5 mg/ml with commercial Norvasc 5 mg tablets.
    Het doel van dit onderzoek is om de farmacokinetische parameters van de nieuw ontwikkelde amlodipine besilaat orale drank 0,5 mg/ml en commerciele Norvasc 5 mg tabletten te bepalen en te vergelijken.
    E.2.2Secondary objectives of the trial
    The secondary objective is to assess the taste of the oral liquid.
    Het secundaire doel is om de smaak van de orale drank te bepalen.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •Subject is healthy
    •Subject is Caucasian
    •Age is between 18-55 years
    •Body Mass Index (BMI) is between 19-25
    •Written informed consent
    •Proefpersoon is gezond
    •Proefpersoon is Kaukasisch
    •Leeftijd is tussen 18-55 jaar
    •Body Mass Index (BMI) ligt tussen 19-25
    •Toestemmingsverklaring is getekend
    E.4Principal exclusion criteria
    Sitting blood pressure lower than 120 mmHg systolic and/or 80 mmHg diastolic in resting conditions
    •Use of medication, both medicines on prescription and over-the-counter medicines, excluding contraceptives
    •Subject is familiar with one of the contra-indications of amlodipine: hypersensitivity to dihydropyridine derivatives, severe hypotension, shock (including cardiogenic shock), obstruction of the outflow tract of the left ventricle (e.g. aortic stenosis), hemodynamically unstable heart failure after acute myocardial infarction (16-17)
    •Allergy for one of the substances of both formulations
    •Pregnancy
    •Smoking
    •Subject has history of alcohol or drug abuse
    •Bloeddruk lager dan 120 mmHg systolische en/of 80 mmHg diastolische bloeddruk in rust gemeten als de proefpersoon zit
    •Gebruik van geneesmiddelen, zowel op recept als vrij verkrijgbare middelen, met uitzondering van anticonceptie.
    •Proefpersoon is bekend met een van de contra-indicaties van amlodipine: overgevoeligheid voor dihydropyridine derivaten, ernstige hypotensie, shock (inclusief cardiale shock), verstopping van het uitgaande bloedvat van de linker ventrikel (oftewel stenose van de aorta), hemodynamisch instabiel hartfalen na een acuut myocard infarct
    •Allergie voor een van de bestanddelen van een van de onderzoeksgeneesmiddelen
    •Zwangerschap
    •Roken
    •Proefpersoon heeft een verleden met alcohol- of drugsmisbruik
    E.5 End points
    E.5.1Primary end point(s)
    The pharmacokinetic parameters Cmax, tmax, AUC0-72, AUC∞ of amlodipine besilate oral liquid 0,5 mg/ml and Norvasc tablets 5 mg will be assessed.
    De farmacokinetische parameters Cmax, tmax, AUC0-72 en AUC∞ van amlodipine besilaat orale drank 0,5 mg/ml en Norvasc tabletten 5 mg zullen worden bepaald.
    E.5.1.1Timepoint(s) of evaluation of this end point
    All pharmacokinetic parameters will be evaluated after completion of the study.
    Alle farmacokinetische parameters zullen geevalueerd worden nadat het onderzoek voltooid is.
    E.5.2Secondary end point(s)
    Secondary, the taste of the amlodipine besilate oral liquid 0,5 mg/ml will to be determined using a questionnaire.
    aast de farmacokinetiek zal ook de smaak van de amlodipine besilaat orale drank 0,5 mg/ml beoordeeld worden aan de hand van een vragenlijst.
    E.5.2.1Timepoint(s) of evaluation of this end point
    The taste of amlodipine besilate oral liquid 0,5 mg/ml will be evaluated by the subjects directly after intake using a questionnaire. The questionnaires will be evaluated by the investigators after completion of the study.
    De smaak van amlodipine besilaat orale drank 0,5 mg/ml zal door de proefpersonen direct na inname beoordeeld worden aan de hand van een vragenlijst. De vragelijsten zullen geevalueerd worden door de onderzoekers nadat het onderzoek voltooid is.
    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 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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Andere formulering (amlodipine (Norvasc) tablet 5 mg)
    Other formulation (amlodipine (Norvasc) tablet 5 mg)
    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
    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 months3
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months3
    E.8.9.2In all countries concerned by the trial 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: 12
    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 state12
    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
    Geen
    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 Decision2012-11-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-02-04
    P. End of Trial
    P.End of Trial StatusOngoing
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