ID

37683

Descrição

Study ID: 105377 Clinical Study ID: 105377 Study Title: A randomised, open-label, parallel-group design study to evaluate the pharmacokinetic characteristics, safety and tolerability of single oral doses of three prototype 300mg enteric coated - modified release formulations of Lamotrigine in healthy subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Lamotrigine Study Indication: Epilepsy

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Versões (1)
  1. 16/08/2019 16/08/2019 -
Titular dos direitos

GlaxoSmithKline

Transferido a

16 de agosto de 2019

DOI

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Licença

Creative Commons BY-NC 3.0
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Pharmacokinetic characteristics, safety and tolerability of single oral doses of three prototype 300mg enteric coated - modified release formulations of Lamotrigine (Study ID: 105377)

Inglês

Pharmacogenetics - Research Consent; Research Withdrawal of Consent

1 Formulários  
Pharmacogenetic Research Consent
Descrição

Pharmacogenetic Research Consent

Alias
UMLS CUI-1
C0021430
UMLS CUI-2
C2347500
Has informed consent been obtained for PGx-Pharmacogenetic research?
Descrição

Has informed consent been obtained for PGx-Pharmacogenetic research?

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C2347500
If informed consent has been obtained for PGx-Pharmacogenetic research, record Date informed consent obtained for PGx-Pharmacogenetic research.
Descrição

Date informed consent obtained for PGx-Pharmacogenetic research

Tipo de dados

date

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C2347500
UMLS CUI [1,3]
C0011008
Has a blood sample been collected for PGx-pharmacogenetic (DNA) research?
Descrição

Has a blood sample been collected for PGx-pharmacogenetic (DNA) research?

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C2347500
UMLS CUI [1,2]
C0005834
If a blood sample has been collected for PGx-pharmacogenetic (DNA) research, record Date sample taken.
Descrição

Date blood sample has been collected for PGx-pharmacogenetic (DNA) research

Tipo de dados

date

Alias
UMLS CUI [1,1]
C2347500
UMLS CUI [1,2]
C0005834
UMLS CUI [1,3]
C0011008
UMLS CUI [2,1]
C2347500
UMLS CUI [2,2]
C0005834
UMLS CUI [2,3]
C0040223
If informed consent has not been obtained for PGx-Pharmacogenetic research, check reason.
Descrição

Reason for informed consent has not been obtained for PGx-Pharmacogenetic research

Tipo de dados

integer

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C2347500
UMLS CUI [1,3]
C2826287
If other reason for informed consent has not been obtained for PGx-Pharmacogenetic research, specify.
Descrição

Other reason for informed consent has not been obtained for PGx-Pharmacogenetic research

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C2347500
UMLS CUI [1,3]
C2826287
UMLS CUI [1,4]
C0205394
UMLS CUI [1,5]
C2348235
Pharmacogenetic Research Withdrawal of Consent
Descrição

Pharmacogenetic Research Withdrawal of Consent

Alias
UMLS CUI-1
C1707492
UMLS CUI-2
C0031325
Has subject withdrawn consent for PGx research?
Descrição

Has subject withdrawn consent for PGx research?

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1707492
UMLS CUI [1,2]
C2347500
Has a request been made for sample destruction?
Descrição

Has a request been made for sample destruction?

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1948029
UMLS CUI [1,2]
C0178913
UMLS CUI [1,3]
C1272683
If a request has been made for sample destruction, check reason.
Descrição

Reason for request for sample destruction

Tipo de dados

integer

Alias
UMLS CUI [1,1]
C1948029
UMLS CUI [1,2]
C0178913
UMLS CUI [1,3]
C1272683
UMLS CUI [1,4]
C0392360
If other reason for request for sample destruction, specify.
Descrição

If other reason for request for sample destruction, specify.

Tipo de dados

text

Alias
UMLS CUI [1,1]
C1948029
UMLS CUI [1,2]
C0178913
UMLS CUI [1,3]
C1272683
UMLS CUI [1,4]
C0392360
UMLS CUI [1,5]
C0205394
UMLS CUI [1,6]
C2348235
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Similar models

Pharmacogenetics - Research Consent; Research Withdrawal of Consent

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
Pharmacogenetic Research Consent
C0021430 (UMLS CUI-1)
C2347500 (UMLS CUI-2)
Has informed consent been obtained for PGx-Pharmacogenetic research?
Item
Has informed consent been obtained for PGx-Pharmacogenetic research?
boolean
C0021430 (UMLS CUI [1,1])
C2347500 (UMLS CUI [1,2])
Date informed consent obtained for PGx-Pharmacogenetic research
Item
If informed consent has been obtained for PGx-Pharmacogenetic research, record Date informed consent obtained for PGx-Pharmacogenetic research.
date
C0021430 (UMLS CUI [1,1])
C2347500 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Has a blood sample been collected for PGx-pharmacogenetic (DNA) research?
Item
Has a blood sample been collected for PGx-pharmacogenetic (DNA) research?
boolean
C2347500 (UMLS CUI [1,1])
C0005834 (UMLS CUI [1,2])
Date blood sample has been collected for PGx-pharmacogenetic (DNA) research
Item
If a blood sample has been collected for PGx-pharmacogenetic (DNA) research, record Date sample taken.
date
C2347500 (UMLS CUI [1,1])
C0005834 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C2347500 (UMLS CUI [2,1])
C0005834 (UMLS CUI [2,2])
C0040223 (UMLS CUI [2,3])
Item
If informed consent has not been obtained for PGx-Pharmacogenetic research, check reason.
integer
C0021430 (UMLS CUI [1,1])
C2347500 (UMLS CUI [1,2])
C2826287 (UMLS CUI [1,3])
Reason for informed consent has not been obtained for PGx-Pharmacogenetic research
Code List
If informed consent has not been obtained for PGx-Pharmacogenetic research, check reason.
CL Item
Subject declined (1)
CL Item
Subject not asked by Investigator (2)
CL Item
Other, specify (3)
Other reason for informed consent has not been obtained for PGx-Pharmacogenetic research
Item
If other reason for informed consent has not been obtained for PGx-Pharmacogenetic research, specify.
text
C0021430 (UMLS CUI [1,1])
C2347500 (UMLS CUI [1,2])
C2826287 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
C2348235 (UMLS CUI [1,5])
Item Group
Pharmacogenetic Research Withdrawal of Consent
C1707492 (UMLS CUI-1)
C0031325 (UMLS CUI-2)
Has subject withdrawn consent for PGx research?
Item
Has subject withdrawn consent for PGx research?
boolean
C1707492 (UMLS CUI [1,1])
C2347500 (UMLS CUI [1,2])
Has a request been made for sample destruction?
Item
Has a request been made for sample destruction?
boolean
C1948029 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
C1272683 (UMLS CUI [1,3])
Item
If a request has been made for sample destruction, check reason.
integer
C1948029 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
C1272683 (UMLS CUI [1,3])
C0392360 (UMLS CUI [1,4])
Reason for request for sample destruction
Code List
If a request has been made for sample destruction, check reason.
CL Item
Subject withdrew consent for PGx (1)
CL Item
Screen failure (2)
CL Item
Other, specify (3)
If other reason for request for sample destruction, specify.
Item
If other reason for request for sample destruction, specify.
text
C1948029 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
C1272683 (UMLS CUI [1,3])
C0392360 (UMLS CUI [1,4])
C0205394 (UMLS CUI [1,5])
C2348235 (UMLS CUI [1,6])
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