ID

36203

Beschreibung

Study ID: 101963 Clinical Study ID: SCA101963 Study Title: A randomised, blinded, parallel group study to investigate the potential pharmacokinetic interaction between lamotrigine and risperidone in healthy, non-smoking, male volunteers. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: lamotrigine Trade Name: Lamictal XR,Lamictal,LAMICTIN Study Indication: Schizophrenia

Stichworte

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  1. 22.04.19 22.04.19 -
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GlaxoSmithKline

Hochgeladen am

22. April 2019

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Potential Pharmacokinetic Interaction between Lamotrigine and Risperidone; 101963

Englisch

Period 2 Day 68-69

1 Formulare  
  1. StudyEvent: ODM
    1. Period 2 Day 68-69
Administrative Data
Beschreibung

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Identifier
Beschreibung

Clinical Trial Subject Unique Identifier

Datentyp

integer

Alias
UMLS CUI [1]
C2348585
Drug Screen
Beschreibung

Drug Screen

Alias
UMLS CUI-1
C0373483
Date and time of sample taken
Beschreibung

Drug screen, Sampling, Date in time, Time

Datentyp

datetime

Alias
UMLS CUI [1,1]
C0373483
UMLS CUI [1,2]
C0870078
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C0040223
Cocaine
Beschreibung

Drug screen, Cocaine

Datentyp

text

Alias
UMLS CUI [1,1]
C0373483
UMLS CUI [1,2]
C0009170
Amphetamines
Beschreibung

Drug screen, Amphetamines

Datentyp

text

Alias
UMLS CUI [1,1]
C0373483
UMLS CUI [1,2]
C0002667
Benzodiazepines
Beschreibung

Drug screen, Benzodiazepines

Datentyp

text

Alias
UMLS CUI [1,1]
C0373483
UMLS CUI [1,2]
C0005064
Cannabinoids
Beschreibung

Drug screen, Cannabinoids

Datentyp

text

Alias
UMLS CUI [1,1]
C0373483
UMLS CUI [1,2]
C0006864
Opiates
Beschreibung

Drug screen, Opiates

Datentyp

text

Alias
UMLS CUI [1,1]
C0373483
UMLS CUI [1,2]
C0376196
Barbiturates
Beschreibung

Drug screen, Barbiturates

Datentyp

text

Alias
UMLS CUI [1,1]
C0373483
UMLS CUI [1,2]
C0004745
Alcohol Breath Test
Beschreibung

Alcohol Breath Test

Alias
UMLS CUI-1
C0202306
Date sample taken
Beschreibung

Ethanol measurement, breath, Date in time

Datentyp

date

Alias
UMLS CUI [1,1]
C0202306
UMLS CUI [1,2]
C0011008
Results
Beschreibung

Ethanol measurement, breath, Result

Datentyp

text

Alias
UMLS CUI [1,1]
C0202306
UMLS CUI [1,2]
C1274040
Pregnancy
Beschreibung

Pregnancy

Alias
UMLS CUI-1
C0032961
Was a pregnancy test performed?
Beschreibung

Pregnancy Tests

Datentyp

text

Alias
UMLS CUI [1]
C0032976
Results
Beschreibung

Pregnancy Tests, Result

Datentyp

text

Alias
UMLS CUI [1,1]
C0032976
UMLS CUI [1,2]
C1274040
Electronically transferred laboratory data - Clinical Chemistry, Haematology
Beschreibung

Electronically transferred laboratory data - Clinical Chemistry, Haematology

Alias
UMLS CUI-1
C0008000
UMLS CUI-2
C0018941
Date Sample Taken
Beschreibung

Chemistry, Clinical, Hematologic tests, Sampling, Date in time

Datentyp

date

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0018941
UMLS CUI [1,3]
C0870078
UMLS CUI [1,4]
C0011008
Actual Time
Beschreibung

Chemistry, Clinical, Hematologic tests, Sampling, Time

Datentyp

time

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0018941
UMLS CUI [1,3]
C0870078
UMLS CUI [1,4]
C0040223
Electronically transferred laboratory data - Urinalysis
Beschreibung

Electronically transferred laboratory data - Urinalysis

Alias
UMLS CUI-1
C0042014
Date Sample Taken
Beschreibung

Urinalysis, Sampling, Date in time

Datentyp

date

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0870078
UMLS CUI [1,3]
C0011008
Actual Time
Beschreibung

Urinalysis, Sampling, Time

Datentyp

time

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0870078
UMLS CUI [1,3]
C0040223
Investigational Product
Beschreibung

Investigational Product

Alias
UMLS CUI-1
C0304229
Planned Relative Time
Beschreibung

Experimental drug, Relative time, Planned

Datentyp

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0439564
UMLS CUI [1,3]
C1301732
Date of Dose
Beschreibung

Experimental drug, Dosage, Date in time

Datentyp

date

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0011008
Time of Dose
Beschreibung

Experimental drug, Dosage, Time

Datentyp

time

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0040223
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Ähnliche Modelle

Period 2 Day 68-69

1 Formulare
  1. StudyEvent: ODM
    1. Period 2 Day 68-69
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Clinical Trial Subject Unique Identifier
Item
Subject Identifier
integer
C2348585 (UMLS CUI [1])
Item Group
Drug Screen
C0373483 (UMLS CUI-1)
Drug screen, Sampling, Date in time, Time
Item
Date and time of sample taken
datetime
C0373483 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Item
Cocaine
text
C0373483 (UMLS CUI [1,1])
C0009170 (UMLS CUI [1,2])
Drug screen, Cocaine
Code List
Cocaine
CL Item
Positive (1)
CL Item
Negative (2)
Item
Amphetamines
text
C0373483 (UMLS CUI [1,1])
C0002667 (UMLS CUI [1,2])
Drug screen, Cocaine
Code List
Amphetamines
CL Item
Positive (1)
CL Item
Negative (2)
Item
Benzodiazepines
text
C0373483 (UMLS CUI [1,1])
C0005064 (UMLS CUI [1,2])
Drug screen, Cocaine
Code List
Benzodiazepines
CL Item
Positive (1)
CL Item
Negative (2)
Item
Cannabinoids
text
C0373483 (UMLS CUI [1,1])
C0006864 (UMLS CUI [1,2])
Drug screen, Cocaine
Code List
Cannabinoids
CL Item
Positive (1)
CL Item
Negative (2)
Item
Opiates
text
C0373483 (UMLS CUI [1,1])
C0376196 (UMLS CUI [1,2])
Drug screen, Cocaine
Code List
Opiates
CL Item
Positive (1)
CL Item
Negative (2)
Item
Barbiturates
text
C0373483 (UMLS CUI [1,1])
C0004745 (UMLS CUI [1,2])
Drug screen, Cocaine
Code List
Barbiturates
CL Item
Positive (1)
CL Item
Negative (2)
Item Group
Alcohol Breath Test
C0202306 (UMLS CUI-1)
Ethanol measurement, breath, Date in time
Item
Date sample taken
date
C0202306 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Results
text
C0202306 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
Ethanol measurement, breath, Result
Code List
Results
CL Item
Positive (1)
CL Item
Negative (2)
Item Group
Pregnancy
C0032961 (UMLS CUI-1)
Item
Was a pregnancy test performed?
text
C0032976 (UMLS CUI [1])
Pregnancy Tests
Code List
Was a pregnancy test performed?
CL Item
Yes (1)
CL Item
No (2)
CL Item
Not Applicable (not of childbearing potential or male) (3)
Item
Results
text
C0032976 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
Pregnancy Tests, Result
Code List
Results
CL Item
Positive (1)
CL Item
Negative (2)
Item Group
Electronically transferred laboratory data - Clinical Chemistry, Haematology
C0008000 (UMLS CUI-1)
C0018941 (UMLS CUI-2)
Chemistry, Clinical, Hematologic tests, Sampling, Date in time
Item
Date Sample Taken
date
C0008000 (UMLS CUI [1,1])
C0018941 (UMLS CUI [1,2])
C0870078 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
Chemistry, Clinical, Hematologic tests, Sampling, Time
Item
Actual Time
time
C0008000 (UMLS CUI [1,1])
C0018941 (UMLS CUI [1,2])
C0870078 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Item Group
Electronically transferred laboratory data - Urinalysis
C0042014 (UMLS CUI-1)
Urinalysis, Sampling, Date in time
Item
Date Sample Taken
date
C0042014 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Urinalysis, Sampling, Time
Item
Actual Time
time
C0042014 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Item Group
Investigational Product
C0304229 (UMLS CUI-1)
Item
Planned Relative Time
text
C0304229 (UMLS CUI [1,1])
C0439564 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,3])
Experimental drug, Relative time, Planned
Code List
Planned Relative Time
CL Item
Day 68 - AM (1)
CL Item
Day 68 - PM (2)
CL Item
Day 69 - AM (3)
CL Item
Day 69 - PM (4)
Experimental drug, Dosage, Date in time
Item
Date of Dose
date
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Experimental drug, Dosage, Time
Item
Time of Dose
time
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
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