ID
37609
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 Trade Name: N/A Study Indication: Epilepsy
Keywords
Versions (3)
- 8/11/19 8/11/19 -
- 8/11/19 8/11/19 -
- 8/12/19 8/12/19 -
Copyright Holder
GlaxoSmithKline
Uploaded on
August 11, 2019
DOI
To request one please log in.
License
Creative Commons BY-NC 3.0
Model comments :
You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.
Itemgroup comments for :
Item comments for :
In order to download data models you must be logged in. Please log in or register for free.
Pharmacokinetic characteristics, safety and tolerability of single oral doses of three prototype 300mg enteric coated - modified release formulations of Lamotrigine
Screen - Administrative; Demography; Vital Signs
- StudyEvent: ODM
Description
Subject Number
Alias
- UMLS CUI-1
- C2348585
Description
Date of Visit/ Assessment
Alias
- UMLS CUI-1
- C1320303
- UMLS CUI-2
- C2985720
Description
Demography
Alias
- UMLS CUI-1
- C0011298
Description
Date of Birth
Data type
date
Alias
- UMLS CUI [1]
- C0421451
Description
Sex
Data type
text
Alias
- UMLS CUI [1]
- C0079399
Description
Ethnicity
Data type
integer
Description
Check all that apply.
Data type
integer
Description
Vital Signs
Alias
- UMLS CUI-1
- C0518766
Description
Actual date/time
Data type
datetime
Alias
- UMLS CUI [1]
- C1264639
Description
Height
Data type
integer
Measurement units
- cm
Alias
- UMLS CUI [1]
- C0005890
Description
Weight
Data type
float
Measurement units
- kg
Alias
- UMLS CUI [1]
- C0005910
Description
Body mass index
Data type
integer
Alias
- UMLS CUI [1]
- C1305855
Description
Systolic Blood pressure
Data type
integer
Measurement units
- mm[Hg]
Alias
- UMLS CUI [1]
- C0871470
Description
Diastolic Blood pressure
Data type
integer
Measurement units
- mm[Hg]
Alias
- UMLS CUI [1]
- C0428883
Description
Heart rate
Data type
integer
Measurement units
- beats/min
Alias
- UMLS CUI [1]
- C0018810
Similar models
Screen - Administrative; Demography; Vital Signs
- StudyEvent: ODM
C2986440 (UMLS CUI [1,2])
C2985720 (UMLS CUI-2)
C2985720 (UMLS CUI [1,2])