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A clinical trial to evaluate the pharmacokinetics ans safety of NVP-1402 compared with Exelon capsule in healthy male subjects

Status Approved

  • First Submitted Date

    2018/07/02

  • Registered Date

    2018/09/21

  • Last Updated Date

    2018/07/10

CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

  • 1. Background

    Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
    CRIS
    Registration Number
    KCT0003213
    Unique Protocol ID NVP-1402-01
    Public/Brief Title A Study to Evaluate the Safety and Pharmacokinetics of NVP-1402
    Scientific Title A clinical trial to evaluate the pharmacokinetics ans safety of NVP-1402 compared with Exelon capsule in healthy male subjects
    Acronym NVP-1402-01
    MFDS Regulated Study Yes
    IND/IDE Protocol Yes
    Registered at Other Registry Yes
    Name of Registry / Registration Number ClinicalTrials.gov-NCT02897726
    Healthcare Benefit Approval Status Not applicable
  • 2. Institutional Review Board / Ethics Committee

    Institutional Review Board Information
    Board Approval Status Submitted approval
    Board Approval Number KNUH 2016-10-014-001
    Approval Date 2016-11-21
    Institutional Review Board Name Kyungpook national university hospital IRB
    Institutional Review Board Address 130, Dongdeok-ro, Jung-gu, Daegu
    Institutional Review Board Telephone 053-200-5430
    Data Monitoring Committee No
  • 3. Contact Details

    Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
    Contact Person for Principal Investigator / Scientific Queries
    Name Young Ran Yoon
    Title Ph.D
    Telephone +82-53-420-4950
    Affiliation Kyungpook National University
    Address 130 Dongdeok-ro, Jung-gu, Daegu 41944, Korea
    Contact Person for Public Queries
    Name Young Ran Yoon
    Title Ph.D
    Telephone +82-53-420-4950
    Affiliation Kyungpook National University
    Address 130 Dongdeok-ro, Jung-gu, Daegu 41944, Korea
    Contact Person for Updating Information
    Name Sol Ip Kang
    Title CRM
    Telephone +82-70-5118-2226
    Affiliation NVP Healthcare
    Address 5, Jangan-ro 448beon-gil, Jangan-gu, Suwon-si, Gyeonggi-do, 16209, Korea
  • 4. Status

    Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
    Study Site Single
    Overall Recruitment Status Completed
    Date of First Enrollment 2017-03-13 Actual
    Target Number of Participant 38
    Primary Completion Date 2017-04-02 , Actual
    Study Completion Date 2017-07-03 , Actual
    Recruitment Status by Participating Study Site 1
    Name of Study Kyungpook National University Hospital
    Recruitment Status Completed
    Date of First Enrollment 2017-03-13 ,
  • 5. Source of Monetary / Material Support

    Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
    1. Source of Monetary/Material Support
    Organization Name NVP Healthcare
    Organization Type Pharmaceutical Company
    Project ID
  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name NVP Healthcare
    Organization Type Pharmaceutical Company
  • 7. Study Summary

    Study Summary Information
    Lay Summary
    The purpose of this study is to evaluate and compare the safety and pharmacokinetics of NVP-1402 and exelon capsule in healthy male subjects.
    
    Randomized, open-label, single oral dose, active-controlled and crossover
  • 8. Study Design

    Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
    Study Type Interventional Study
    Study Purpose
    Treatment
    Phase Phase1
    Intervention Model Cross-over  
    Blinding/Masking Open
    Allocation RCT
    Intervention Type Drug  
    Intervention Description
    Arm1: Comparator Exelon capsule 3mg 1cap, BID / wash out 7days, Test drug NVP-1402 6mg 1Tablet, 1tab, once daily
    Arm2: Test drug NVP-1402 6mg 1Tablet, 1tab, once daily  / wash out 7days,  Comparator Exelon capsule 3mg 1cap, BID
    Number of Arms 2
    Arm 1

    Arm Label

    Comparator

    Target Number of Participant

    19

    Arm Type

    Others

    Arm Description

    Exelon capsule 3mg 1capsule, BID (single oral dose), wash out 7days, Test drug NVP-1402 6mg 1Tablet, 1tab, once daily single oral dose)
    Arm 2

    Arm Label

    Test drug

    Target Number of Participant

    19

    Arm Type

    Others

    Arm Description

    Test drug NVP-1402 6mg 1Tablet, 1tab, once daily  / wash out 7days,  Comparator Exelon capsule 3mg 1cap, BID (single oral dose)
  • 9. Subject Eligibility

    Subject Eligibility Information
    Condition(s)/Problem(s) * (F00-F99)Mental and behavioural disorders 
       (F03)Unspecified dementia 
    Rare Disease No
    Inclusion Criteria

    Gender

    Male

    Age

    19Year~No Limit

    Description

    1)Healthy adult male volunteers aged 19years old at screening
    2)Body weight  50 kg within the range of ± 20% of the calculated ideal body weight (IBW)
     IBW(kg) = {height (cm) – 100} x 0.9
    3)Without any congenital or chronic diseases requiring treatment, any pathological symptoms, or any abnormal findings on medical examination
    4)Subjects evaluated eligible for the study based on the screening test results such as laboratory tests including serology, hematology, blood chemistry, and urinalysis, etc. and electrocardiogram(ECG).
    5)Subjects who signed on the written informed consent form and comply with study requirements after listening and fully understanding the details of this study.
    Exclusion Criteria
    1) Subjects with hypersensitivity to the active ingredients or other components of the investigational product(s) or medical history of significant hypersensitivity to other drugs or any additive(s). 
    2) Subjects with medical history to affect absorption, distribution, metabolism and elimination of drug(s) (disease(s) of hepatic/biliary, renal, cardiovascular, endocrine (hypothyroidism etc.), respiratory, digestive, hematologic, central nervous, psychiatric, musculoskeletal systems, etc.)
    3) Subjects with active liver disease or alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels >1.5 times the upper limit of the normal range
    4) Subjects with creatinine clearance <80 mL/min (Creatinine clearance calculated by Cockcroft-Gault’s formula using serum creatinine).
    5) Subjects with gastrointestinal disease (Crohn's disease, active peptic ulcer disease, etc.) that would affect absorption of investigational products or history of gastrointestinal surgery (except for simple appendectomy or hernia surgery) 
    6) Subjects with serious harms, surgical procedures or suspected symptoms of acute disease(s) (severe infection, severe injury, etc.) within 4 weeks prior to the first administration.
    7) Subjects who continued excessive drinking alcohol (>21 units/week, 1unit=10g=12.5 mL of pure alcohol) or could not abstain from alcohol since 3 days before the day to conduct the study or excessive smokers (> 10 cigarettes /day).
    8) History of Substance abuse
    9) Ingesting any prescription drug(s) or herbal medicine(s) within 2 weeks prior to the first administration or any over-the-counter (OTC) drug(s) judged by the investigator to affect this study or the safety of the study subjects. 
    10) Subjects who participated in any other study within 3 months prior to the first administration (the end of the previous study is determined as the last day of administration).
    11) Subjects who donated whole blood or partial blood within 2 or 1 month, respectively, prior to the first administration.
    12) Subjects on abnormal diets which might affect absorption, distribution, metabolism and elimination of drug(s) or taking foods which might affect drug metabolism.(eg, grapefruit juice (1L or more per day) taken within 7 days prior to administration of the Investigational Product)
    13) Someone who can't take a meal derived from this trial
    14) Subjects with positive result of serologic test (HBsAg, HCV Ab, HIV Ab)
    15) Subjects judged not eligible for this study by principal investigator or subinvestigator (physician in charge).
    Healthy Volunteers Yes
  • 10. Outcome Measure(s)

    Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
    Type of Primary Outcome /Safety/Efficacy
    Primary Outcome(s) 1
    Outcome
    Rivastigmine of  Cmax, AUClast
    Timepoint
    -	Test drug: For each period  pre-dose(0h), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12,14, 16, 24h / -	Comparator: For each period, pre-dose(0h), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 12.5, 13, 13.5, 14, 14.5, 15, 16, 17, 18, 24h
    Secondary Outcome(s) 1
    Outcome
    Rivastigmine of AUCinf, Tmax, t1/2
    Timepoint
    -	Test drug: For each period  pre-dose(0h), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12,14, 16, 24h / -	Comparator: For each period, pre-dose(0h), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 12.5, 13, 13.5, 14, 14.5, 15, 16, 17, 18, 24h
  • 11. Study Results and Publication

    Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
    Result Registered No
  • 12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

    Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
    Sharing Statement No
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