ID

37681

Description

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

Keywords

Versions (1)
  1. 8/16/19 8/16/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

August 16, 2019

DOI

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License

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)

English

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

1 forms  
Electronically Transferred Lab Data
Description

Electronically Transferred Lab Data

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

Laboratory Test Type

Data type

text

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

Date and time sample taken

Data type

datetime

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

Vital signs

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

Vital Signs - Subject position

Data type

text

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

Vital Signs - Actual date/time

Data type

datetime

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

Vital Signs - Blood pressure

Data type

integer

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

Vital Signs - Systolic blood pressure

Data type

integer

Measurement units
  • mm[Hg]
Alias
UMLS CUI [1,1]
C0439565
UMLS CUI [1,2]
C0871470
mm[Hg]
Vital Signs - Diastolic blood pressure
Description

Vital Signs - Diastolic blood pressure

Data type

integer

Measurement units
  • mm[Hg]
Alias
UMLS CUI [1,1]
C0439565
UMLS CUI [1,2]
C0428883
mm[Hg]
Vital Signs - Heart rate
Description

Vital Signs - Heart rate

Data type

integer

Measurement units
  • beats/min
Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0018810
beats/min
Pharmacokinetics Blood (Lamotrigine)
Description

Pharmacokinetics Blood (Lamotrigine)

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

Pharmacokinetics Blood (Lamotrigine) - Doing Date and Time

Data type

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
Description

Pharmacokinetics Blood (Lamotrigine) - Actual date/ time

Data type

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 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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