ID

33256

Beskrivning

Study ID: 107434 Clinical Study ID: NAP107434 Study Title: A randomised, double-blind, double-dummy, placebo controlled, three-way cross-over study to investigate the effect of single oral doses of 100 mg GW273225 (4030W92) and 325 mg LAMICTAL on resting motor threshold in healthy subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Study Link: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GW273225 Trade Name: lamictal Study Indication: Bipolar Disorder This form contains informations about the study drug administration on day 1. It should be filled out at the first treatment period. Screening Visit: 28 days prior to first dosing. Treatment Period: The day before dosing, until 48h after dosing. Follow-Up: 14-21 days after last dose

Nyckelord

Versioner (2)
  1. 2018-12-03 2018-12-03 -
  2. 2018-12-18 2018-12-18 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

3 december 2018

DOI

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Licens

Creative Commons BY-NC 3.0
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Effect of Lamictal on Resting Motor Threshold

Engelsk

Study Drug Administration Day 1

1 Formulär  
Administrative Data
Beskrivning

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Screening number
Beskrivning

Subject Screening No.

Datatyp

integer

Alias
UMLS CUI [1,1]
C0220908
UMLS CUI [1,2]
C0600091
Subject no.
Beskrivning

Subject Number

Datatyp

integer

Alias
UMLS CUI [1]
C2348585
Study Drug Administration
Beskrivning

Study Drug Administration

Alias
UMLS CUI-1
C3469597
Study Day
Beskrivning

Study Day

Datatyp

integer

Alias
UMLS CUI [1]
C2826182
Date Administered
Beskrivning

Date of Drug Administration

Datatyp

date

Alias
UMLS CUI [1,1]
C3469597
UMLS CUI [1,2]
C0011008
Time Administered
Beskrivning

Time Drug Administered

Datatyp

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C3469597
Number of Tablets administered
Beskrivning

Number of Tablets

Datatyp

integer

Alias
UMLS CUI [1,1]
C0039225
UMLS CUI [1,2]
C0237753
Comment
Beskrivning

Comment

Datatyp

text

Alias
UMLS CUI [1]
C0947611
Staff Member Administering Drug
Beskrivning

Clin staff init

Datatyp

text

Alias
UMLS CUI [1,1]
C1552089
UMLS CUI [1,2]
C2348343
Staff Member Checking Administration
Beskrivning

Clin staff init

Datatyp

text

Alias
UMLS CUI [1,1]
C1552089
UMLS CUI [1,2]
C3469597
UMLS CUI [1,3]
C1283174
Conclusion
Beskrivning

Conclusion

Alias
UMLS CUI-1
C1707478
Staff initials
Beskrivning

Staff initials

Datatyp

text

Alias
UMLS CUI [1,1]
C2986440
UMLS CUI [1,2]
C1552089
Date
Beskrivning

Date

Datatyp

date

Alias
UMLS CUI [1]
C0011008
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Similar models

Study Drug Administration Day 1

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Subject Screening No.
Item
Subject Screening number
integer
C0220908 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Subject Number
Item
Subject no.
integer
C2348585 (UMLS CUI [1])
Item Group
Study Drug Administration
C3469597 (UMLS CUI-1)
Item
Study Day
integer
C2826182 (UMLS CUI [1])
Study Day
Code List
Study Day
CL Item
1 (1)
Date of Drug Administration
Item
Date Administered
date
C3469597 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Time Drug Administered
Item
Time Administered
time
C0040223 (UMLS CUI [1,1])
C3469597 (UMLS CUI [1,2])
Number of Tablets
Item
Number of Tablets administered
integer
C0039225 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Comment
Item
Comment
text
C0947611 (UMLS CUI [1])
Staff Member Administering Drug
Item
Staff Member Administering Drug
text
C1552089 (UMLS CUI [1,1])
C2348343 (UMLS CUI [1,2])
Staff Member Checking Administration
Item
Staff Member Checking Administration
text
C1552089 (UMLS CUI [1,1])
C3469597 (UMLS CUI [1,2])
C1283174 (UMLS CUI [1,3])
Item Group
Conclusion
C1707478 (UMLS CUI-1)
Staff initials
Item
Staff initials
text
C2986440 (UMLS CUI [1,1])
C1552089 (UMLS CUI [1,2])
Date
Item
Date
date
C0011008 (UMLS CUI [1])
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