ID

37681

Descripción

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

Palabras clave

Versiones (1)
  1. 16/8/19 16/8/19 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

16 de agosto de 2019

DOI

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Licencia

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)

Inglés

Logs/ Repeats - Electronically Transferred Lab Data; Vital Signs; Pharmacokinetics Blood

1 formularios  
Electronically Transferred Lab Data
Descripción

Electronically Transferred Lab Data

Alias
UMLS CUI-1
C0200345
UMLS CUI-2
C0022885
UMLS CUI-3
C1320722
Laboratory Test Type
Descripción

Laboratory Test Type

Tipo de datos

text

Alias
UMLS CUI [1]
C0022885
Date and time sample taken
Descripción

Date and time sample taken

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C0200345
UMLS CUI [1,2]
C0011008
UMLS CUI [2,1]
C0200345
UMLS CUI [2,2]
C0040223
Vital signs
Descripción

Vital signs

Alias
UMLS CUI-1
C0518766
Vital Signs - Subject position
Descripción

Vital Signs - Subject position

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C1262869
Vital Signs - Actual date/time
Descripción

Vital Signs - Actual date/time

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C1264639
Vital Signs - Blood pressure
Descripción

Vital Signs - Blood pressure

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0005823
Vital Signs - Systolic blood pressure
Descripción

Vital Signs - Systolic blood pressure

Tipo de datos

integer

Unidades de medida
  • mm[Hg]
Alias
UMLS CUI [1,1]
C0439565
UMLS CUI [1,2]
C0871470
mm[Hg]
Vital Signs - Diastolic blood pressure
Descripción

Vital Signs - Diastolic blood pressure

Tipo de datos

integer

Unidades de medida
  • mm[Hg]
Alias
UMLS CUI [1,1]
C0439565
UMLS CUI [1,2]
C0428883
mm[Hg]
Vital Signs - Heart rate
Descripción

Vital Signs - Heart rate

Tipo de datos

integer

Unidades de medida
  • beats/min
Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0018810
beats/min
Pharmacokinetics Blood (Lamotrigine)
Descripción

Pharmacokinetics Blood (Lamotrigine)

Alias
UMLS CUI-1
C0031328
UMLS CUI-2
C0005767
UMLS CUI-3
C0064636
Pharmacokinetics Blood (Lamotrigine) - Doing Date and Time
Descripción

Pharmacokinetics Blood (Lamotrigine) - Doing Date and Time

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0005767
UMLS CUI [1,3]
C0064636
UMLS CUI [1,4]
C0178602
UMLS CUI [1,5]
C0011008
UMLS CUI [2,1]
C0031328
UMLS CUI [2,2]
C0005767
UMLS CUI [2,3]
C0064636
UMLS CUI [2,4]
C0178602
UMLS CUI [2,5]
C0040223
Pharmacokinetics Blood (Lamotrigine) - Actual date/ time
Descripción

Pharmacokinetics Blood (Lamotrigine) - Actual date/ time

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0005767
UMLS CUI [1,3]
C0064636
UMLS CUI [1,4]
C1264639
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Similar models

Logs/ Repeats - Electronically Transferred Lab Data; Vital Signs; Pharmacokinetics Blood

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Electronically Transferred Lab Data
C0200345 (UMLS CUI-1)
C0022885 (UMLS CUI-2)
C1320722 (UMLS CUI-3)
Item
Laboratory Test Type
text
C0022885 (UMLS CUI [1])
Laboratory Test Type
Code List
Laboratory Test Type
CL Item
Haematology (H)
CL Item
Clinical Chemistry (C)
CL Item
Urinalysis (U)
Date and time sample taken
Item
Date and time sample taken
datetime
C0200345 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0200345 (UMLS CUI [2,1])
C0040223 (UMLS CUI [2,2])
Item Group
Vital signs
C0518766 (UMLS CUI-1)
Item
Vital Signs - Subject position
text
C0518766 (UMLS CUI [1,1])
C1262869 (UMLS CUI [1,2])
Vital Signs - Subject position
Code List
Vital Signs - Subject position
CL Item
Supine (S)
CL Item
Semi Supine (SS)
CL Item
Sitting (SI)
CL Item
Standing (ST)
Vital Signs - Actual date/time
Item
Vital Signs - Actual date/time
datetime
C0518766 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
Item
Vital Signs - Blood pressure
integer
C0518766 (UMLS CUI [1,1])
C0005823 (UMLS CUI [1,2])
Blood pressure
Code List
Vital Signs - Blood pressure
CL Item
Not done (1)
Vital Signs - Systolic blood pressure
Item
Vital Signs - Systolic blood pressure
integer
C0439565 (UMLS CUI [1,1])
C0871470 (UMLS CUI [1,2])
Vital Signs - Diastolic blood pressure
Item
Vital Signs - Diastolic blood pressure
integer
C0439565 (UMLS CUI [1,1])
C0428883 (UMLS CUI [1,2])
Vital Signs - Heart rate
Item
Vital Signs - Heart rate
integer
C0518766 (UMLS CUI [1,1])
C0018810 (UMLS CUI [1,2])
Item Group
Pharmacokinetics Blood (Lamotrigine)
C0031328 (UMLS CUI-1)
C0005767 (UMLS CUI-2)
C0064636 (UMLS CUI-3)
Pharmacokinetics Blood (Lamotrigine) - Doing Date and Time
Item
Pharmacokinetics Blood (Lamotrigine) - Doing Date and Time
datetime
C0031328 (UMLS CUI [1,1])
C0005767 (UMLS CUI [1,2])
C0064636 (UMLS CUI [1,3])
C0178602 (UMLS CUI [1,4])
C0011008 (UMLS CUI [1,5])
C0031328 (UMLS CUI [2,1])
C0005767 (UMLS CUI [2,2])
C0064636 (UMLS CUI [2,3])
C0178602 (UMLS CUI [2,4])
C0040223 (UMLS CUI [2,5])
Pharmacokinetics Blood (Lamotrigine) - Actual date/ time
Item
datetime
C0031328 (UMLS CUI [1,1])
C0005767 (UMLS CUI [1,2])
C0064636 (UMLS CUI [1,3])
C1264639 (UMLS CUI [1,4])
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