ID

33969

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 information about any unscheduled blood sampling for pharmakokinetics. It should be filled out at each visit, if any unscheduled blood samples for pharmacokinetics had been taken. 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 (3)
  1. 2018-12-03 2018-12-03 -
  2. 2018-12-19 2018-12-19 -
  3. 2019-01-09 2019-01-09 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

9 januari 2019

DOI

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Creative Commons BY-NC 3.0
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Effect of Lamictal on Resting Motor Threshold Study-ID 107434

Engelsk

Unscheduled Blood Sampling for PK

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
Were any unscheduled blood sampling for PK conducted?
Beskrivning

Unscheduled Blood Sampling

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C3854240
Staff initials
Beskrivning

Staff initials

Datatyp

text

Alias
UMLS CUI [1,1]
C2986440
UMLS CUI [1,2]
C1552089
Unscheduled Blood Sampling for PK
Beskrivning

Unscheduled Blood Sampling for PK

Alias
UMLS CUI-1
C0005834
UMLS CUI-2
C3854240
UMLS CUI-3
C0031327
Date
Beskrivning

Date

Datatyp

date

Alias
UMLS CUI [1]
C0011008
Actual Time
Beskrivning

Actual Time

Datatyp

time

Alias
UMLS CUI [1]
C0040223
Sample Number
Beskrivning

Sample Number

Datatyp

text

Alias
UMLS CUI [1]
C1299222
PK sample type number
Beskrivning

PK sample type number

Datatyp

integer

Alias
UMLS CUI [1,1]
C0201734
UMLS CUI [1,2]
C1299222
Clinical Staff Initials
Beskrivning

Clinical Staff Initials

Datatyp

text

Alias
UMLS CUI [1,1]
C2986440
UMLS CUI [1,2]
C0871685
Reason for Unscheduled Sample
Beskrivning

Reason for Unscheduled Sample

Datatyp

text

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0005834
UMLS CUI [1,3]
C3854240
Tillbaka till toppen

Similar models

Unscheduled Blood Sampling for PK

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])
Unscheduled Blood Sampling
Item
Were any unscheduled blood sampling for PK conducted?
boolean
C0005834 (UMLS CUI [1,1])
C3854240 (UMLS CUI [1,2])
Staff initials
Item
Staff initials
text
C2986440 (UMLS CUI [1,1])
C1552089 (UMLS CUI [1,2])
Item Group
Unscheduled Blood Sampling for PK
C0005834 (UMLS CUI-1)
C3854240 (UMLS CUI-2)
C0031327 (UMLS CUI-3)
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Actual Time
Item
Actual Time
time
C0040223 (UMLS CUI [1])
Sample Number
Item
Sample Number
text
C1299222 (UMLS CUI [1])
Item
PK sample type number
integer
C0201734 (UMLS CUI [1,1])
C1299222 (UMLS CUI [1,2])
PK sample type number
Code List
PK sample type number
CL Item
1 (1)
Clinical Staff Initials
Item
Clinical Staff Initials
text
C2986440 (UMLS CUI [1,1])
C0871685 (UMLS CUI [1,2])
Reason for Unscheduled Sample
Item
Reason for Unscheduled Sample
text
C0392360 (UMLS CUI [1,1])
C0005834 (UMLS CUI [1,2])
C3854240 (UMLS CUI [1,3])
Tillbaka till toppen 

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