0 Avaliações

ID

39192

Descrição

Study ID: 103106 Clinical Study ID: WXL103106 Study Title:An open-label, 2-period, sequential treatment, 1-way drug interaction study to evaluate the effect of ritonavir on bupropion pharmacokinetics in healthy volunteers Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: bupropion Trade Name: Wellbutrin,QUOMEM,Elontril,Zyban,ZYNTABAC; Zyban,ZYNTABAC,Wellbutrin,Wellburin,QUOMEM,Prolev,Magerion,Geronplase,Elontril Study Indication: Depressive Disorder

Palavras-chave

  1. 08/12/2019 08/12/2019 -
Titular dos direitos

GlaxoSmithKline

Transferido a

8 de dezembro de 2019

DOI

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Licença

Creative Commons BY-NC 3.0

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    Effect of Ritonavir on Bupropion Pharmacokinetics; 103106

    Study Conclusion

    1. StudyEvent: ODM
      1. Study Conclusion
    Administrative Data
    Descrição

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722 (Administrative documentation)
    SNOMED
    405624007
    Subject Identifier
    Descrição

    Clinical Trial Subject Unique Identifier

    Tipo de dados

    integer

    Alias
    UMLS CUI [1]
    C2348585 (Clinical Trial Subject Unique Identifier)
    Study Conclusion
    Descrição

    Study Conclusion

    Alias
    UMLS CUI-1
    C0008976 (Clinical Trials)
    SNOMED
    110465008
    LOINC
    LP231796-6
    UMLS CUI-2
    C1707478 (Conclusion)
    Date of subject completion or withdrawal
    Descrição

    Clinical Trials, End Date

    Tipo de dados

    date

    Alias
    UMLS CUI [1,1]
    C0008976 (Clinical Trials)
    SNOMED
    110465008
    LOINC
    LP231796-6
    UMLS CUI [1,2]
    C0806020 (End date)
    SNOMED
    454551000124105
    LOINC
    MTHU008302
    Time of withdrawal
    Descrição

    Clinical Trials, Withdraw, Time

    Tipo de dados

    time

    Alias
    UMLS CUI [1,1]
    C0008976 (Clinical Trials)
    SNOMED
    110465008
    LOINC
    LP231796-6
    UMLS CUI [1,2]
    C2349954 (Withdraw (activity))
    UMLS CUI [1,3]
    C0040223 (Time)
    SNOMED
    410670007
    LOINC
    LP73517-2
    Was the subject withdrawn from the study?
    Descrição

    Clinical Trials, Withdraw

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0008976 (Clinical Trials)
    SNOMED
    110465008
    LOINC
    LP231796-6
    UMLS CUI [1,2]
    C2349954 (Withdraw (activity))
    If Yes, check the primary reason for withdrawal
    Descrição

    Clinical Trials, Withdraw, Reason and justification

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C0008976 (Clinical Trials)
    SNOMED
    110465008
    LOINC
    LP231796-6
    UMLS CUI [1,2]
    C2349954 (Withdraw (activity))
    UMLS CUI [1,3]
    C0566251 (Reason and justification)
    SNOMED
    288830005
    Other, specify
    Descrição

    Clinical Trials, Withdraw, Reason and justification

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C0008976 (Clinical Trials)
    SNOMED
    110465008
    LOINC
    LP231796-6
    UMLS CUI [1,2]
    C2349954 (Withdraw (activity))
    UMLS CUI [1,3]
    C0566251 (Reason and justification)
    SNOMED
    288830005

    Similar models

    Study Conclusion

    1. StudyEvent: ODM
      1. Study Conclusion
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de dados
    Alias
    Item Group
    Administrative Data
    C1320722 (UMLS CUI-1)
    Clinical Trial Subject Unique Identifier
    Item
    Subject Identifier
    integer
    C2348585 (UMLS CUI [1])
    Item Group
    Study Conclusion
    C0008976 (UMLS CUI-1)
    C1707478 (UMLS CUI-2)
    Clinical Trials, End Date
    Item
    Date of subject completion or withdrawal
    date
    C0008976 (UMLS CUI [1,1])
    C0806020 (UMLS CUI [1,2])
    Clinical Trials, Withdraw, Time
    Item
    Time of withdrawal
    time
    C0008976 (UMLS CUI [1,1])
    C2349954 (UMLS CUI [1,2])
    C0040223 (UMLS CUI [1,3])
    Clinical Trials, Withdraw
    Item
    Was the subject withdrawn from the study?
    boolean
    C0008976 (UMLS CUI [1,1])
    C2349954 (UMLS CUI [1,2])
    Item
    If Yes, check the primary reason for withdrawal
    text
    C0008976 (UMLS CUI [1,1])
    C2349954 (UMLS CUI [1,2])
    C0566251 (UMLS CUI [1,3])
    Code List
    If Yes, check the primary reason for withdrawal
    CL Item
    Adverse event  (1)
    CL Item
    Lost to follow-up (2)
    CL Item
    Protocol violation (3)
    CL Item
    Subject decided to withdraw from the study  (4)
    CL Item
    Lack of efficacy (5)
    CL Item
    Sponsor terminated study (6)
    CL Item
    Other, specify (7)
    Clinical Trials, Withdraw, Reason and justification
    Item
    Other, specify
    text
    C0008976 (UMLS CUI [1,1])
    C2349954 (UMLS CUI [1,2])
    C0566251 (UMLS CUI [1,3])

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