ID

37637

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 (3)
  1. 8/11/19 8/11/19 -
  2. 8/11/19 8/11/19 -
  3. 8/12/19 8/12/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

August 12, 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

English

Screen - Administrative; Demography; Vital Signs (Study ID: 105377)

1 forms  
Inform Screening
Description

Inform Screening

Alias
UMLS CUI-1
C1552002
UMLS CUI-2
C1710032
Subject initials
Description

Subject initials

Data type

text

Alias
UMLS CUI [1,1]
C1997894
UMLS CUI [1,2]
C2986440
Date of Birth
Description

Date of Birth

Data type

date

Alias
UMLS CUI [1]
C0421451
Subject Number
Description

Subject Number

Alias
UMLS CUI-1
C2348585
Subject Number
Description

Subject Number

Data type

text

Alias
UMLS CUI [1]
C2348585
Date of Visit/ Assessment
Description

Date of Visit/ Assessment

Alias
UMLS CUI-1
C1320303
UMLS CUI-2
C2985720
Date of Visit/ Assessment
Description

Date of Visit/ Assessment

Data type

date

Alias
UMLS CUI [1,1]
C1320303
UMLS CUI [1,2]
C2985720
Demography
Description

Demography

Alias
UMLS CUI-1
C0011298
Date of Birth
Description

Date of Birth

Data type

date

Alias
UMLS CUI [1]
C0421451
Sex
Description

Sex

Data type

text

Alias
UMLS CUI [1]
C0079399
Ethnicity
Description

Ethnicity

Data type

integer

Race
Description

Check all that apply.

Data type

integer

Vital Signs
Description

Vital Signs

Alias
UMLS CUI-1
C0518766
Actual date/time
Description

Actual date/time

Data type

datetime

Alias
UMLS CUI [1]
C1264639
Height
Description

Height

Data type

integer

Measurement units
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Weight
Description

Weight

Data type

float

Measurement units
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Body mass index
Description

Body mass index

Data type

integer

Alias
UMLS CUI [1]
C1305855
Systolic Blood pressure
Description

Systolic Blood pressure

Data type

integer

Measurement units
  • mm[Hg]
Alias
UMLS CUI [1]
C0871470
mm[Hg]
Diastolic Blood pressure
Description

Diastolic Blood pressure

Data type

integer

Measurement units
  • mm[Hg]
Alias
UMLS CUI [1]
C0428883
mm[Hg]
Heart rate
Description

Heart rate

Data type

integer

Measurement units
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
Subject Number
Description

Subject Number

Alias
UMLS CUI-1
C1709561
Subject Number
Description

Subject Number

Data type

text

Alias
UMLS CUI [1]
C1709561
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Similar models

Screen - Administrative; Demography; Vital Signs (Study ID: 105377)

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inform Screening
C1552002 (UMLS CUI-1)
C1710032 (UMLS CUI-2)
Subject initials
Item
Subject initials
text
C1997894 (UMLS CUI [1,1])
C2986440 (UMLS CUI [1,2])
Date of Birth
Item
Date of Birth
date
C0421451 (UMLS CUI [1])
Item Group
Subject Number
C2348585 (UMLS CUI-1)
Subject Number
Item
Subject Number
text
C2348585 (UMLS CUI [1])
Item Group
Date of Visit/ Assessment
C1320303 (UMLS CUI-1)
C2985720 (UMLS CUI-2)
Date of Visit/ Assessment
Item
Date of Visit/ Assessment
date
C1320303 (UMLS CUI [1,1])
C2985720 (UMLS CUI [1,2])
Item Group
Demography
C0011298 (UMLS CUI-1)
Date of Birth
Item
Date of Birth
date
C0421451 (UMLS CUI [1])
Item
Sex
text
C0079399 (UMLS CUI [1])
Sex
Code List
Sex
CL Item
Male (M)
CL Item
Female : Record child-bearing porential (F)
CL Item
Pre-menarcheal (1)
CL Item
Post-menopausal (2)
CL Item
Sterile (of child-bearing age) (3)
CL Item
Potentially able to bear children (4)
Item
Ethnicity
integer
Ethnicity
Code List
Ethnicity
CL Item
Hispanic or Latino (1)
CL Item
Not Hispanic or Latino (2)
Item
Race
integer
Race
Code List
Race
CL Item
African American/African Heritage (11)
CL Item
American Indian or Alaskan Native (12)
CL Item
Asian - Central/South Asian Heritage (13)
CL Item
Asian - East Asian Heritage (14)
CL Item
Asian - Japanese Heritage (15)
CL Item
Asian - South East Asian Heritage (16)
CL Item
Native Hawaiian or Other Pacific blander (17)
CL Item
White - Arabic/North African Heritage (18)
CL Item
White - White/Caucasian/European Heritage (19)
Item Group
Vital Signs
C0518766 (UMLS CUI-1)
Actual date/time
Item
Actual date/time
datetime
C1264639 (UMLS CUI [1])
Height
Item
Height
integer
C0005890 (UMLS CUI [1])
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Body mass index
Item
Body mass index
integer
C1305855 (UMLS CUI [1])
Systolic Blood pressure
Item
Systolic Blood pressure
integer
C0871470 (UMLS CUI [1])
Diastolic Blood pressure
Item
Diastolic Blood pressure
integer
C0428883 (UMLS CUI [1])
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Item Group
Subject Number
C1709561 (UMLS CUI-1)
Subject Number
Item
Subject Number
text
C1709561 (UMLS CUI [1])
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