ID
36179
Description
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
Keywords
Versions (1)
- 4/22/19 4/22/19 -
Copyright Holder
GlaxoSmithKline
Uploaded on
April 22, 2019
DOI
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License
Creative Commons BY-NC 3.0
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Potential Pharmacokinetic Interaction between Lamotrigine and Risperidone; 101963
Screening
- StudyEvent: ODM
Description
Demography
Alias
- UMLS CUI-1
- C0011298
Description
Patient date of birth
Data type
date
Alias
- UMLS CUI [1]
- C0421451
Description
Gender
Data type
text
Alias
- UMLS CUI [1]
- C0079399
Description
Ethnic group
Data type
text
Alias
- UMLS CUI [1]
- C0015031
Description
Racial group
Data type
text
Alias
- UMLS CUI [1]
- C0034510
Description
Vital Signs
Alias
- UMLS CUI-1
- C0518766
Description
Body Height
Data type
integer
Measurement units
- cm
Alias
- UMLS CUI [1]
- C0005890
Description
Body Weight
Data type
float
Measurement units
- kg
Alias
- UMLS CUI [1]
- C0005910
Description
Body mass index
Data type
float
Measurement units
- kg/m2
Alias
- UMLS CUI [1]
- C1305855
Description
Vital Signs Date
Data type
date
Alias
- UMLS CUI [1]
- C2826644
Description
Vital Signs Time
Data type
text
Alias
- UMLS CUI [1]
- C2826762
Description
Systolic Pressure
Data type
integer
Measurement units
- mmHg
Alias
- UMLS CUI [1]
- C0871470
Description
Diastolic blood pressure
Data type
integer
Measurement units
- mmHg
Alias
- UMLS CUI [1]
- C0428883
Description
Standing, Semi-Supine
Data type
text
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C1262869
Description
Heart Rate
Data type
integer
Measurement units
- bpm
Alias
- UMLS CUI [1]
- C0018810
Description
Medical Conditions
Alias
- UMLS CUI-1
- C0012634
Description
Disease, Diagnosis
Data type
text
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0011900
Description
Disease, Current or past
Data type
text
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C1444635
Description
Drug Screen
Alias
- UMLS CUI-1
- C0373483
Description
Drug screen, Sampling, Date in time, Time
Data type
datetime
Alias
- UMLS CUI [1,1]
- C0373483
- UMLS CUI [1,2]
- C0870078
- UMLS CUI [1,3]
- C0011008
- UMLS CUI [1,4]
- C0040223
Description
Drug screen, Cocaine
Data type
text
Alias
- UMLS CUI [1,1]
- C0373483
- UMLS CUI [1,2]
- C0009170
Description
Drug screen, Amphetamines
Data type
text
Alias
- UMLS CUI [1,1]
- C0373483
- UMLS CUI [1,2]
- C0002667
Description
Drug screen, Benzodiazepines
Data type
text
Alias
- UMLS CUI [1,1]
- C0373483
- UMLS CUI [1,2]
- C0005064
Description
Drug screen, Cannabinoids
Data type
text
Alias
- UMLS CUI [1,1]
- C0373483
- UMLS CUI [1,2]
- C0006864
Description
Drug screen, Opiates
Data type
text
Alias
- UMLS CUI [1,1]
- C0373483
- UMLS CUI [1,2]
- C0376196
Description
Drug screen, Barbiturates
Data type
text
Alias
- UMLS CUI [1,1]
- C0373483
- UMLS CUI [1,2]
- C0004745
Description
Alcohol Breath Test
Alias
- UMLS CUI-1
- C0202306
Description
Pregnancy
Alias
- UMLS CUI-1
- C0032961
Description
Serology - HIV Screen
Alias
- UMLS CUI-1
- C0459958
- UMLS CUI-2
- C0036743
Description
HIV screen, Serologic tests, Sampling, Date in time
Data type
date
Alias
- UMLS CUI [1,1]
- C0459958
- UMLS CUI [1,2]
- C0036743
- UMLS CUI [1,3]
- C0870078
- UMLS CUI [1,4]
- C0011008
Description
HIV Antibodies
Data type
text
Alias
- UMLS CUI [1]
- C0019683
Description
Hepatitis B Surface Antigens
Data type
text
Alias
- UMLS CUI [1]
- C0019168
Description
Hepatitis C antibody measurement
Data type
text
Alias
- UMLS CUI [1]
- C0201487
Description
Electronically transferred laboratory data - Clinical Chemistry, Haematology
Alias
- UMLS CUI-1
- C0008000
- UMLS CUI-2
- C0018941
Description
Chemistry, Clinical, Hematologic tests, Sampling, Date in time
Data type
date
Alias
- UMLS CUI [1,1]
- C0008000
- UMLS CUI [1,2]
- C0018941
- UMLS CUI [1,3]
- C0870078
- UMLS CUI [1,4]
- C0011008
Description
Chemistry, Clinical, Hematologic tests, Sampling, Time
Data type
time
Alias
- UMLS CUI [1,1]
- C0008000
- UMLS CUI [1,2]
- C0018941
- UMLS CUI [1,3]
- C0870078
- UMLS CUI [1,4]
- C0040223
Description
Electronically transferred laboratory data - Urinalysis
Alias
- UMLS CUI-1
- C0042014
Description
Urinalysis, Sampling, Date in time
Data type
date
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C0870078
- UMLS CUI [1,3]
- C0011008
Description
Urinalysis, Sampling, Time
Data type
time
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C0870078
- UMLS CUI [1,3]
- C0040223
Description
Holter ECG
Alias
- UMLS CUI-1
- C0013801
Description
Holter Electrocardiography, Start Date
Data type
date
Alias
- UMLS CUI [1,1]
- C0013801
- UMLS CUI [1,2]
- C0808070
Description
Holter Electrocardiography, Start Time
Data type
time
Alias
- UMLS CUI [1,1]
- C0013801
- UMLS CUI [1,2]
- C1301880
Description
Holter Electrocardiography, End Date
Data type
date
Alias
- UMLS CUI [1,1]
- C0013801
- UMLS CUI [1,2]
- C0806020
Description
Holter Electrocardiography, End Time
Data type
time
Alias
- UMLS CUI [1,1]
- C0013801
- UMLS CUI [1,2]
- C1522314
Description
Holter Electrocardiography, Result
Data type
text
Alias
- UMLS CUI [1,1]
- C0013801
- UMLS CUI [1,2]
- C1274040
Description
12-Lead ECG
Alias
- UMLS CUI-1
- C0430456
Description
12 lead ECG, Start Date
Data type
date
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0808070
Description
12 lead ECG, End Date
Data type
date
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0806020
Description
12 lead ECG, Relative time, Planned
Data type
text
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0439564
- UMLS CUI [1,3]
- C1301732
Description
12 lead ECG, Start Time
Data type
time
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1301880
Description
12 lead ECG, End Time
Data type
time
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1522314
Description
12 lead ECG, Heart rate
Data type
integer
Measurement units
- bpm
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0018810
Description
12 lead ECG, PR Interval
Data type
integer
Measurement units
- msec
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0429087
Description
12 lead ECG, QRS complex duration
Data type
integer
Measurement units
- msec
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0429025
Description
12 lead ECG, QT Interval
Data type
integer
Measurement units
- msec
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1287082
Description
12 lead ECG, QT corrected Interval
Data type
integer
Measurement units
- msec
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0855331
Description
12 lead ECG, Result
Data type
integer
Measurement units
- msec
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1274040
Description
12-Lead ECG Abnormalities
Alias
- UMLS CUI-1
- C0430456
- UMLS CUI-2
- C1704258
Description
12 lead ECG, Date in time
Data type
date
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0011008
Description
12 lead ECG, Time
Data type
time
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0040223
Description
12 lead ECG, Abnormality, Rhythm
Data type
text
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1704258
- UMLS CUI [1,3]
- C0199556
Description
12 lead ECG, Abnormality, electrocardiogram: P wave shifting morphology, Electrocardiogram QRS complex
Data type
text
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1704258
- UMLS CUI [1,3]
- C2216025
- UMLS CUI [1,4]
- C0429098
Description
12 lead ECG, Abnormality, Cardiac conduction
Data type
text
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1704258
- UMLS CUI [1,3]
- C0232217
Description
12 lead ECG, Abnormality, Myocardial Infarction
Data type
text
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1704258
- UMLS CUI [1,3]
- C0027051
Description
12 lead ECG, Abnormality, Ventricular Depolarization [PE], Electrocardiogram repolarisation abnormality
Data type
text
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1704258
- UMLS CUI [1,3]
- C1331539
- UMLS CUI [1,4]
- C0948857
Description
12 lead ECG, Abnormality, Other
Data type
text
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1704258
- UMLS CUI [1,3]
- C0205394
Description
Eligibility Question
Alias
- UMLS CUI-1
- C0013893
Description
Inclusion Criteria
Alias
- UMLS CUI-1
- C1512693
Description
Health Status; Tobacco use; Age; Pregnancy; Breastfeeding
Data type
boolean
Alias
- UMLS CUI [1]
- C0018759
- UMLS CUI [2]
- C0543414
- UMLS CUI [3]
- C0001779
- UMLS CUI [4]
- C0032961
- UMLS CUI [5]
- C0006147
Description
post-Menopause; Hysterectomy; Contraceptive usage
Data type
boolean
Alias
- UMLS CUI [1]
- C0206159
- UMLS CUI [2]
- C0020699
- UMLS CUI [3]
- C0009899
Description
Body Weight; Body mass index
Data type
boolean
Alias
- UMLS CUI [1]
- C0005910
- UMLS CUI [2]
- C1305855
Description
Health status
Data type
boolean
Alias
- UMLS CUI [1]
- C0018759
Description
QT interval
Data type
boolean
Alias
- UMLS CUI [1]
- C1287082
Description
Informed Consent
Data type
boolean
Alias
- UMLS CUI [1]
- C0021430
Description
Protocol Compliance
Data type
boolean
Alias
- UMLS CUI [1]
- C0525058
Description
Exclusion Criteria
Alias
- UMLS CUI-1
- C0680251
Description
Exanthema, Drug-induced
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0015230
- UMLS CUI [1,2]
- C0458082
Description
Syncope
Data type
boolean
Alias
- UMLS CUI [1]
- C0039070
Description
Hypotension, Orthostatic
Data type
boolean
Alias
- UMLS CUI [1]
- C0020651
Description
Hypotension
Data type
boolean
Alias
- UMLS CUI [1]
- C0020649
Description
Systolic pressure; Diastolic blood pressure
Data type
boolean
Alias
- UMLS CUI [1]
- C0871470
- UMLS CUI [2]
- C0428883
Description
Seizures
Data type
boolean
Alias
- UMLS CUI [1]
- C0036572
Description
Craniocerebral Trauma
Data type
boolean
Alias
- UMLS CUI [1]
- C0018674
Description
Poor metabolizer; cytochrome p450 2D6 genotype
Data type
boolean
Alias
- UMLS CUI [1,1]
- C3845231
- UMLS CUI [1,2]
- C2164095
Description
Hypotension, Orthostatic
Data type
boolean
Alias
- UMLS CUI [1]
- C0020651
Description
Blood Pressure, Decrease
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0005823
- UMLS CUI [1,2]
- C0547047
Description
Urine drug test; Ethanol measurement, breath
Data type
boolean
Alias
- UMLS CUI [1]
- C0202274
- UMLS CUI [2]
- C0202306
Description
HIV Antibodies; Hepatitis B surface antigen; Hepatitis C antibody
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0019683
- UMLS CUI [1,2]
- C0369334
- UMLS CUI [1,3]
- C0166049
Description
Substance Use Disorders; Alcohol Abuse
Data type
boolean
Alias
- UMLS CUI [1]
- C0038586
- UMLS CUI [2]
- C0085762
Description
Study Subject Participation Status
Data type
boolean
Alias
- UMLS CUI [1]
- C2348568
Description
Pharmaceutical Preparations; Vitamins; Dietary Supplements; Herbal Supplements; Anti-Inflammatory Agents, Non-Steroidal
Data type
boolean
Alias
- UMLS CUI [1]
- C0013227
- UMLS CUI [2]
- C0042890
- UMLS CUI [3]
- C0242295
- UMLS CUI [4]
- C1504473
- UMLS CUI [5]
- C0003211
Description
Hormonal Contraception; Hormone Replacement therapy
Data type
boolean
Alias
- UMLS CUI [1]
- C2985296
- UMLS CUI [2]
- C0282402
Description
Pharmaceutical Preparations, Hypersensitivity
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0020517
Description
Gastrointestinal Diseases; Liver diseases; Kidney Diseases; Drug Metabolism Alteration
Data type
boolean
Alias
- UMLS CUI [1]
- C0017178
- UMLS CUI [2]
- C0023895
- UMLS CUI [3]
- C0022658
- UMLS CUI [4]
- C1512073
Description
Grapefruit; Cytochrome P450 3A4 Inducer
Data type
boolean
Alias
- UMLS CUI [1]
- C0995150
- UMLS CUI [2]
- C3830625
Description
Blood Donation
Data type
boolean
Alias
- UMLS CUI [1]
- C0005794
Description
Strenuous Exercise; Abstinence
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1514989
- UMLS CUI [1,2]
- C3843422
Description
Alcohol Abstinence; Caffeine, Abstinence
Data type
boolean
Alias
- UMLS CUI [1]
- C0678274
- UMLS CUI [2,1]
- C0006644
- UMLS CUI [2,2]
- C3843422
Similar models
Screening
- StudyEvent: ODM
C1262869 (UMLS CUI [1,2])
C0011900 (UMLS CUI [1,2])
C1444635 (UMLS CUI [1,2])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
C0002667 (UMLS CUI [1,2])
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C0011008 (UMLS CUI [1,4])
C0018941 (UMLS CUI [1,2])
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C0870078 (UMLS CUI [1,2])
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C0808070 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,2])
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C1274040 (UMLS CUI [1,2])
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C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
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C0199556 (UMLS CUI [1,3])
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C0232217 (UMLS CUI [1,3])
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C1704258 (UMLS CUI [1,2])
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C0948857 (UMLS CUI [1,4])
C1704258 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0543414 (UMLS CUI [2])
C0001779 (UMLS CUI [3])
C0032961 (UMLS CUI [4])
C0006147 (UMLS CUI [5])
C0020699 (UMLS CUI [2])
C0009899 (UMLS CUI [3])
C1305855 (UMLS CUI [2])
C0458082 (UMLS CUI [1,2])
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C0085762 (UMLS CUI [2])
C0042890 (UMLS CUI [2])
C0242295 (UMLS CUI [3])
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C0003211 (UMLS CUI [5])
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C0020517 (UMLS CUI [1,2])
C0023895 (UMLS CUI [2])
C0022658 (UMLS CUI [3])
C1512073 (UMLS CUI [4])
C3830625 (UMLS CUI [2])
C3843422 (UMLS CUI [1,2])
C0006644 (UMLS CUI [2,1])
C3843422 (UMLS CUI [2,2])