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    Summary
    EudraCT Number:2015-003005-41
    Sponsor's Protocol Code Number:CS0866-A-U101
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2015-07-24
    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
    H.4 THIRD COUNTRY IN WHICH THE TRIAL WAS FIRST AUTHORISED
    Expand All   Collapse All
    A. Protocol Information
    A.2EudraCT number2015-003005-41
    A.3Full title of the trial
    A Comparative, Randomized, Single-Dose, 2-Way Crossover Bioavailability Study of a Compounded 4 mg/mL Olmesartan Medoxomil Suspension (Total Dose 40 mg) and 40 mg Olmesartan Medoxomil Tablets (Benicar®) in Healthy Adult Volunteers Under Fasting Conditions
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Olmesartan paediatric formulation bioavailability study
    A.4.1Sponsor's protocol code numberCS0866-A-U101
    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 SponsorSankyo Pharma Development
    B.1.3.4CountryUnited States
    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 supportSankyo Pharma Development
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDaiichi Sankyo Development Ltd.
    B.5.2Functional name of contact pointClinical Trial Information
    B.5.3 Address:
    B.5.3.1Street AddressChiltern Place, Chalfont Park
    B.5.3.2Town/ cityGerrards Cross
    B.5.3.3Post codeSL9 0BG
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number4401753482800
    B.5.6E-mailinfo@dsd-eu.com
    D. IMP Identification
    D.IMP: 1
    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 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 nameBenicar
    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 INNOlmesartan Medoxomil
    D.3.9.1CAS number 144689-63-4
    D.3.9.3Other descriptive nameOLMESARTAN MEDOXOMIL
    D.3.9.4EV Substance CodeSUB03508MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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 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 nameOlmesartan medoxomil
    D.3.4Pharmaceutical form Suspension for use in drinking water
    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 INNOlmesartan Medoxomil
    D.3.9.1CAS number 144689-63-4
    D.3.9.3Other descriptive nameOLMESARTAN MEDOXOMIL
    D.3.9.4EV Substance CodeSUB03508MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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
    Not applicable - Healthy Volunteer study
    E.1.1.1Medical condition in easily understood language
    Not applicable - Healthy Volunteer study
    E.1.1.2Therapeutic area Not possible to specify
    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 objective of the study was to determine if the compounded suspension formulation of olmesartan medoxomil (4 mg/mL × 10 mL, for a total dose of 40 mg) is bioequivalent to the marketed tablet formulation of Benicar® (1 × 40 mg tablet).
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    a) Healthy adult male or female subjects, 18-45 years of age;
    b) Body Mass Index (BMI) between 19-32 kg/m2;
    c) All women must have a negative pregnancy test at Screening, at each check-in (Day -1) and at the end of study (Day 3).
    d) Women with:
    o all three of the following additional criteria:
    - Not pregnant. (Women of childbearing potential must have a negative serum pregnancy test at screening and check in).
    - Not breast-feeding.
    - Do not plan to become pregnant during the study.
    o AND women with one of the following three additional criteria:
    - Surgically sterile (bilateral tubal ligation, hysterectomy, bilateral oophorectomy) 6 months minimum;
    - Have been postmenopausal for at least 2 years (or 1 year with a FSH level 40 mIU/mL).
    - Are of childbearing potential and were practicing one of the following methods of birth control at least 1 month prior to study start and will continue to practice throughout the study:
    • intrauterine device,
    • diaphragm plus spermicide;
    • female condom plus spermicide or partner condom plus spermicide.
    NOTE: Abstinence, partner's use of condoms without spermicide and partner's vasectomy were NOT acceptable methods of contraception.
    e) Negative drug and alcohol screening;
    f) Negative test for HIV antibody, hepatitis B surface antigen, or hepatitis C antibody;
    g) No clinically relevant abnormal finding at screening (physical exam, vital signs, ECGs and laboratory values) as deemed by the Principal Investigator;
    h) Gave voluntary written informed consent to participate in the study.
    E.4Principal exclusion criteria
    a) Used any prescription drug within 7 days of study initiation or any non-prescription drug (including herbal supplements) within 7 days of study initiation;
    b) History or presence of significant cardiovascular disease;
    c) Sitting blood pressure less than 100/50 mmHg at screening or prior to dosing;
    d) Pulse lower than 40 b.p.m. at screening or prior to dosing;
    e) Treatment with any known drug metabolizing enzyme-altering drugs (inducers or inhibitors) within the 30 days prior to dosing;
    f) History of serum sickness or allergic reaction to any drug;
    g) History of drug abuse or alcohol addiction within the last 2 years;
    h) Donation of a unit of blood within the past 56 days prior to study initiation or plasma donation within 7 days of study initiation;
    i) Female subjects who are pregnant or lactating;
    j) Positive test for HIV antibody or hepatitis B (surface antigen) or C (antibody);
    k) Participated in another clinical trial within 28 days prior to the first dose;
    l) Consumed any alcoholic beverages and/or caffeine- or xanthine containing beverages within 48 hours prior to the first dose of each period;
    m) Consumed any food or beverages containing grapefruit from 10 days prior to the first dose of study medication through completion of the study;
    n) Employment by the research center;
    o) First degree familial relationship with another study participant, the Sponsor's associates, or clinical research center personnel;
    p) History of tobacco use for the past 12 months;
    q) Positive urine drug/alcohol screen at screening or check-in;
    r) PR interval is >260 msec at screening and prior to dosing;
    s) QTc interval >450 msec;
    t) Any clinical significant abnormality on electrocardiogram (ECG), as deemed by the Principal Investigator;
    u) Any screening laboratory values outside the range of normal values and deemed clinically significant by the Investigator. Values for specific analytes noted below may not exceed the following limits:
    Hematology
    o Hemoglobin < 12 g/dL
    o Platelet count <100,000
    o Serum Chemistry
    o AST (SGOT) > 1.25 x ULN
    o ALT (SGPT) > 1.25 x ULN
    o Alkaline Phosphatase > 1.25 x ULN
    o Total Bilirubin > 1.25 x ULN
    o BUN > 1.50 x ULN
    o Creatinine Kinase (CK) > 1.50 x ULN
    o Creatinine > 1.20 x ULN



    t) A clinically significant history or evidence of cardiac, hepatic, renal, pulmonary, endocrine, neurologic, infectious, gastrointestinal, hematologic, oncologic, psychiatric disease or other medical condition as determined by screening history, physical examination, and ECG. Clinically significant is defined as that which may pose significant risk to the subject due to participation, or may confound the outcome/results of the study.
    E.5 End points
    E.5.1Primary end point(s)
    Standard pharmacokinetic parameters
    E.5.1.1Timepoint(s) of evaluation of this end point
    60 hours
    E.5.2Secondary end point(s)
    Safety
    E.5.2.1Timepoint(s) of evaluation of this end point
    14d
    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 No
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 trial1
    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
    United States
    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.8.9.2In all countries concerned by the trial months1
    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: 26
    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 26
    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
    H.4 Third Country in which the Trial was first authorised
    H.4.1Third Country in which the trial was first authorised: United States
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