ID
36195
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
Period 2 Day 50
- StudyEvent: ODM
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
Vital Signs
Alias
- UMLS CUI-1
- C0518766
Description
Vital Signs Date
Data type
date
Alias
- UMLS CUI [1]
- C2826644
Description
Vital Signs, Relative time, Planned
Data type
text
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C0439564
- UMLS CUI [1,3]
- C1301732
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
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
12-Lead ECG
Alias
- UMLS CUI-1
- C0430456
Description
12 lead ECG, Numbers
Data type
text
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0237753
Description
12 lead ECG, Start Date
Data type
date
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0808070
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, 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
Investigational Product
Alias
- UMLS CUI-1
- C0304229
Description
Experimental drug, Relative time, Planned
Data type
text
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0439564
- UMLS CUI [1,3]
- C1301732
Description
Experimental drug, Dosage, Date in time
Data type
date
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0178602
- UMLS CUI [1,3]
- C0011008
Description
Experimental drug, Dosage, Time
Data type
time
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0178602
- UMLS CUI [1,3]
- C0040223
Similar models
Period 2 Day 50
- StudyEvent: ODM
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
C0002667 (UMLS CUI [1,2])
C0005064 (UMLS CUI [1,2])
C0006864 (UMLS CUI [1,2])
C0004745 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,2])
C0439564 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,3])
C1262869 (UMLS CUI [1,2])
C0018941 (UMLS CUI-2)
C0018941 (UMLS CUI [1,2])
C0870078 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
C0018941 (UMLS CUI [1,2])
C0870078 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
C0808070 (UMLS CUI [1,2])
C0439564 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,3])
C1301880 (UMLS CUI [1,2])
C0018810 (UMLS CUI [1,2])
C0429087 (UMLS CUI [1,2])
C0429025 (UMLS CUI [1,2])
C1287082 (UMLS CUI [1,2])
C0855331 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,2])
C0439564 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,3])
C0178602 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0178602 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])