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    Summary
    EudraCT Number:2021-001768-95
    Sponsor's Protocol Code Number:0420-20
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2021-03-31
    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
    H.4 THIRD COUNTRY IN WHICH THE TRIAL WAS FIRST AUTHORISED
    Expand All   Collapse All
    A. Protocol Information
    A.2EudraCT number2021-001768-95
    A.3Full title of the trial
    AN OPEN LABEL, BALANCED, RANDOMIZED, TWO-TREATMENT, TWO-PERIOD, TWOSEQUENCE, SINGLE ORAL DOSE, CROSSOVER, COMPARATIVE BIOAVAILABILITY STUDY OF IMATINIB ORAL SOLUTION 800 MG/10 ML (AT A DOSE OF 05 ML) OF INTAS
    PHARMACEUTICALS LTD., INDIA WITH GLIVEC® 400 MG FILM-COATED TABLETS OF
    NOVARTIS PHARMA GMBH, ROONSTRASSE 25, D-90429 NUREMBERG, GERMANY IN
    NORMAL, HEALTHY, ADULT, HUMAN SUBJECTS UNDER FASTING CONDITION
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study of Imatinib oral solution in human subjects
    A.4.1Sponsor's protocol code number0420-20
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/171/2020
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorIntas Pharmaceuticals Ltd.
    B.1.3.4CountryIndia
    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 supportIntas Pharmaceuticals Ltd.
    B.4.2CountryIndia
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIntas Pharmaceuticals Ltd.
    B.5.2Functional name of contact pointMr. Kavan Pandya
    B.5.3 Address:
    B.5.3.1Street AddressCorporate House, Nr. Sola Bridge, S.G. Highway, Thaltej
    B.5.3.2Town/ cityAhmedabad
    B.5.3.3Post code380054
    B.5.3.4CountryIndia
    B.5.4Telephone number917939837000
    B.5.5Fax number917926578862
    B.5.6E-mailkavan_pandya@intaspharma.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 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 nameImatinib Powder for oral solution 800 mg/10 ml
    D.3.4Pharmaceutical form Powder for oral suspension
    D.3.4.1Specific paediatric formulation Yes
    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 INNIMATINIB MESILATE
    D.3.9.1CAS number 220127-57-1
    D.3.9.4EV Substance CodeSUB12517MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number80
    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 Glivec® 400 mg film coated tablets (imatinib)
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Europharm Limited
    D.2.1.2Country which granted the Marketing AuthorisationIreland
    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 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 INNIMATINIB MESILATE
    D.3.9.1CAS number 220127-57-1
    D.3.9.4EV Substance CodeSUB12517MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number400
    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 volunteers (Chronic Myeloid Leukaemia, Acute Lymphoblastic Leukaemia, Myelodysplastic/myeloproliferative diseases, advanced hypereosinophilic syndrome and/or chronic eosinophilic leukaemia)
    E.1.1.1Medical condition in easily understood language
    Not any
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level SOC
    E.1.2Classification code 10005329
    E.1.2Term Blood and lymphatic system disorders
    E.1.2System Organ Class 10005329 - Blood and lymphatic system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare the bioavailability and characterize the pharmacokinetic profile of the sponsors test product with reference product in normal, healthy, adult, human subjects under fasting condition
    E.2.2Secondary objectives of the trial
    To monitor the adverse events and to ensure the safety of the subjects. To evaluate taste/palatability of the sponsor’s test product in order to assess overall subjects compliance
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    a. Non-smoker, normal, healthy adult human volunteers between 18 to 45 years of age (both inclusive).
    b. Having a Body Mass Index (BMI) between 18.5 to 30.0 (both inclusive), calculated as weight in kg / height in m2.
    c. Not having any significant diseases or clinically significant abnormal findings during screening, medical history, clinical examination, laboratory evaluations, 12-lead ECG and X-ray chest (postero-anterior view) recordings.
    d. Able to understand and comply with the study procedures, in the opinion of the investigator.
    e. Able to give voluntary written informed consent for participation in the trial.
    f. In case of female subjects:
    i. Surgically sterilized at least 6 months prior to study participation.
    Or
    If of child bearing potential is willing to use a suitable and effective double barrier contraceptive method or intra uterine device during the study.
    And
    ii. Serum pregnancy test must be negative.
    E.4Principal exclusion criteria
    i. Known hypersensitivity or idiosyncratic reaction to Imatinib or to any of its excipients or any drug or any substance.
    ii. History or presence of any disease or condition which might compromise the haemopoietic, renal, hepatic, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal disorder including bleeding or any other body system disorders.
    iii. Ingestion or use of any medication (including herbal remedies, inhibitors and/or inducers of CYP3A4 family) at any time in 14 days prior to dosing of period I. In any such case subject selection will be at the discretion of the Principal Investigator.
    iv. Any history or presence of asthma (including aspirin induced asthma) or nasal polyp or NSAID induced urticaria.
    v. A recent history of harmful use of alcohol (less than 2 years), i.e. alcohol consumption of more than 14 standard drinks per week for men and more than 7 standard drinks per week for women (A standard drink is defined as 360 ml of beer or 150 ml of wine or 45 ml of 40 % distilled spirits, such as rum, whisky, brandy etc) or consumption of alcohol or alcoholic products within 48 hours prior to receiving study medicine in period I.
    vi. Smokers, or who have smoked within last six months prior to start of the study.
    vii. The presence of clinically significant abnormal laboratory values during screening.
    viii. Use of any recreational drugs or history of drug addiction or testing positive in pre-study drug scans.
    ix. History or presence of seizure or psychiatric disorders.
    x. A history of difficulty with donating blood.
    xi. Donation of blood (1 unit or 350 mL) within a period of 90 days prior to the first dose of study medication.
    xii. Receipt of an investigational medicinal product or participation in a drug research study within a period of 90 days prior to the first dose of study medication**.
    ** If investigational medicinal product is received within 90 days where there is no blood loss except safety lab testing, subject can be included considering 10 half-lives duration of investigational medicinal product received.
    xiii. A positive hepatitis screen including hepatitis B surface antigen and/or HCV antibodies.
    xiv. A positive test result for HIV (1 &/or 2) antibody.
    xv. Consumption of Grapefruits or its products within a period of 72 hours prior to receiving the study drug in period I.
    xvi. Difficulty in swallowing solids dosage forms like tablets or capsules
    xvii. An unusual diet, for whatever reason (e.g. low-sodium), for four weeks prior to receiving the study drug in period I. In any such case subject selection will be at the discretion of the Principal Investigator.
    xviii. Nursing mothers (females)
    E.5 End points
    E.5.1Primary end point(s)
    To compare the bioavailability and characterize the pharmacokinetic profile of the sponsors test product with reference product in normal, healthy, adult, human subjects under fasting condition
    E.5.1.1Timepoint(s) of evaluation of this end point
    A total of 25 blood samples, each of 04 mL will be collected from each
    subject in each period.
    The venous blood samples will be withdrawn at pre dose (0.000 hour) and at
    0.250, 0.500, 0.750, 1.000, 1.333, 1.667, 2.000, 2.333, 2.667, 3.000, 3.333,
    3.667, 4.000, 4.500, 5.000, 6.000, 8.000, 10.000, 12.000, 16.000, 24.000,
    36.000, 48.000 and 72.000 hours post dose following drug administration in
    each period.
    E.5.2Secondary end point(s)
    To monitor the adverse events and to ensure the safety of the subjects. To evaluate taste/palatability of the sponsor’s test product in order to assess overall subjects compliance
    E.5.2.1Timepoint(s) of evaluation of this end point
    Clinical examination- screening, after check-in, before checkout and at the end of the study.
    Laboratory assessment- at the time of screening and hematology & biochemistry- prior to period-II.
    Subjects will be questioned for wellbeing at the time of clinical examinations, during ambulatory sample and during recording of vital signs in each study period.
    Vitals Sitting blood pressure and radial pulse - prior to dosing and at 1, 3, 6, 11, 24 and 36 hrs after dosing in each period.
    Chest X-ray (during the last 6 months) and 12-Lead ECG - during screening.
    Subjects will be informed to refrain from driving or operating machinery during the study
    Subject will be instructed not to participate in other clinical trial or donate blood anywhere else during the study.
    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) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study Yes
    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) No
    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
    Glivec® 400 mg film coated tablets (imatinib)
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 Will this trial be conducted at a single site globally? Yes
    E.8.4 Will this trial be conducted at multiple sites globally? No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.2Trial being conducted completely outside of the EEA Yes
    E.8.6.3Specify the countries outside of the EEA in which trial sites are planned
    India
    E.8.7Trial has a data monitoring committee Yes
    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 the last subject
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months2
    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: 38
    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.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 38
    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
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Lambda Therapeutic Research Ltd.,
    G.4.3.4Network Country India
    H.4 Third Country in which the Trial was first authorised
    H.4.1Third Country in which the trial was first authorised: India
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