ID
37678
Beschrijving
Study ID: 105377 Clinical Study ID: 105377 Study Title: A randomised, open-label, parallel-group design study to evaluate the pharmacokinetic characteristics, safety and tolerability of single oral doses of three prototype 300mg enteric coated - modified release formulations of Lamotrigine in healthy subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Lamotrigine Study Indication: Epilepsy
Trefwoorden
Versies (1)
- 16-08-19 16-08-19 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
16 augustus 2019
DOI
Voor een aanvraag inloggen.
Licentie
Creative Commons BY-NC 3.0
Model Commentaren :
Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.
Itemgroep Commentaren voor :
Item Commentaren voor :
U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.
Pharmacokinetic characteristics, safety and tolerability of single oral doses of three prototype 300mg enteric coated - modified release formulations of Lamotrigine (Study ID: 105377)
Follow-Up - Vital Sigs; 12-Lead ECG; 12-Lead ECG Abnormalities; Electronically Transferred Lab Data; Study Conclusion; Pregnancy Information
Beschrijving
Vital Signs
Alias
- UMLS CUI-1
- C0518766
Beschrijving
Vital Signs - Actual date/time (Pre-dose)
Datatype
datetime
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C1264639
- UMLS CUI [2]
- C0439565
Beschrijving
Systolic Blood pressure
Datatype
integer
Maateenheden
- mm[Hg]
Alias
- UMLS CUI [1]
- C0871470
Beschrijving
Diastolic Blood pressure
Datatype
integer
Maateenheden
- mm[Hg]
Alias
- UMLS CUI [1]
- C0428883
Beschrijving
Vital Signs - Heart rate
Datatype
integer
Maateenheden
- beats/min
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C0018810
Beschrijving
12-Lead ECG
Alias
- UMLS CUI-1
- C0430456
Beschrijving
Date and Time of ECG
Datatype
datetime
Alias
- UMLS CUI [1]
- C2826846
Beschrijving
Heart Rate
Datatype
integer
Maateenheden
- beats/min
Alias
- UMLS CUI [1]
- C0018810
Beschrijving
PR Interval
Datatype
integer
Maateenheden
- ms
Alias
- UMLS CUI [1]
- C0429087
Beschrijving
QRS Duration
Datatype
integer
Maateenheden
- ms
Alias
- UMLS CUI [1]
- C0429025
Beschrijving
Uncorrected QT Interval
Datatype
integer
Maateenheden
- ms
Alias
- UMLS CUI [1]
- C1287082
Beschrijving
QTc Interval
Datatype
integer
Maateenheden
- ms
Alias
- UMLS CUI [1]
- C0489625
Beschrijving
Method of QTc Calculation
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0855331
- UMLS CUI [1,2]
- C2911685
Beschrijving
Result of the ECG
Datatype
integer
Alias
- UMLS CUI [1]
- C0438154
Beschrijving
12-Lead ECG Abnormalities
Beschrijving
Date and Time of ECG
Datatype
datetime
Alias
- UMLS CUI [1]
- C2826846
Beschrijving
Record clinically significant abnormalities
Datatype
text
Alias
- UMLS CUI [1]
- C0232187
Beschrijving
A. If other abnormal rhythm, enter comment
Datatype
text
Alias
- UMLS CUI [1,1]
- C0232187
- UMLS CUI [1,2]
- C0205161
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [1,4]
- C0947611
Beschrijving
Record clinically significant abnormalities
Datatype
text
Alias
- UMLS CUI [1]
- C2216025
Beschrijving
B. If other morphology, enter comment
Datatype
text
Alias
- UMLS CUI [1,1]
- C0332437
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C0947611
Beschrijving
C. Conduction
Datatype
text
Alias
- UMLS CUI [1]
- C0232217
Beschrijving
C. If other conduction, enter comment
Datatype
text
Alias
- UMLS CUI [1,1]
- C0232217
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C0947611
Beschrijving
D. Myocardial Infarction
Datatype
text
Alias
- UMLS CUI [1]
- C0027051
Beschrijving
D. If other myocardial infarction, enter comment
Datatype
text
Alias
- UMLS CUI [1,1]
- C0027051
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C0947611
Beschrijving
E. Depolarisation/Repolarisation (QRS-T)
Datatype
text
Alias
- UMLS CUI [1]
- C1395184
- UMLS CUI [2]
- C0948857
Beschrijving
E. If other depolarisation/ repolarisation, enter comment
Datatype
text
Alias
- UMLS CUI [1,1]
- C1395184
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C0947611
- UMLS CUI [2,1]
- C0948857
- UMLS CUI [2,2]
- C0205394
- UMLS CUI [2,3]
- C0947611
Beschrijving
If other abnormalities, enter comment
Datatype
text
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1704258
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [1,4]
- C0947611
Beschrijving
Electronically Transferred Lab Data
Alias
- UMLS CUI-1
- C0745590
- UMLS CUI-2
- C1705822
Beschrijving
Haematology Date and time sample taken
Datatype
datetime
Alias
- UMLS CUI [1,1]
- C0018941
- UMLS CUI [1,2]
- C0870078
- UMLS CUI [1,3]
- C0011008
- UMLS CUI [1,4]
- C0040223
Beschrijving
Haematology sample not taken
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0018941
- UMLS CUI [1,2]
- C0200345
- UMLS CUI [1,3]
- C1272696
Beschrijving
Clinical Chemistry Date and time sample taken
Datatype
datetime
Alias
- UMLS CUI [1,1]
- C0008000
- UMLS CUI [1,2]
- C0200345
- UMLS CUI [1,3]
- C1264639
Beschrijving
Clinical Chemistry sample not taken
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0008000
- UMLS CUI [1,2]
- C0200345
- UMLS CUI [1,3]
- C1272696
Beschrijving
Clinical Chemistry same as the Haematology sample
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0200345
- UMLS CUI [1,2]
- C0008000
- UMLS CUI [2]
- C0018941
Beschrijving
Urinalysis Date and time sample taken
Datatype
datetime
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C0200345
- UMLS CUI [1,3]
- C1264639
Beschrijving
Urinalysis sample not taken.
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C0200345
- UMLS CUI [1,3]
- C1272696
Beschrijving
Study Conclusion
Alias
- UMLS CUI-1
- C1707478
- UMLS CUI-2
- C0008972
Beschrijving
Date/time of subject completion or withdrawal
Datatype
datetime
Alias
- UMLS CUI [1,1]
- C2983670
- UMLS CUI [1,2]
- C0422727
- UMLS CUI [1,3]
- C0011008
Beschrijving
Was the subject withdrawn from the study'?
Datatype
boolean
Alias
- UMLS CUI [1]
- C0422727
Beschrijving
If subject was withdrawn from the study, specify reason for withdrawal
Datatype
text
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C1549995
Beschrijving
Pregnancy Information
Alias
- UMLS CUI-1
- C0032961
- UMLS CUI-2
- C1533716
Beschrijving
Did the subject become pregnant during the study?
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0032961
- UMLS CUI [1,2]
- C0008976
Beschrijving
Check Not Applicable if female partner not of childbearing potential or no female partner
Datatype
text
Alias
- UMLS CUI [1,1]
- C0919624
- UMLS CUI [1,2]
- C0008972
Similar models
Follow-Up - Vital Sigs; 12-Lead ECG; 12-Lead ECG Abnormalities; Electronically Transferred Lab Data; Study Conclusion; Pregnancy Information
C2985720 (UMLS CUI-2)
C2985720 (UMLS CUI [1,2])
C1264639 (UMLS CUI [1,2])
C0439565 (UMLS CUI [2])
C0018810 (UMLS CUI [1,2])
C2911685 (UMLS CUI [1,2])
C0205161 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0947611 (UMLS CUI [1,4])
C0205394 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,3])
C0948857 (UMLS CUI [2])
C0205394 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,3])
C0948857 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C0947611 (UMLS CUI [2,3])
C1704258 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0947611 (UMLS CUI [1,4])
C1705822 (UMLS CUI-2)
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
C0200345 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
C0200345 (UMLS CUI [1,2])
C1264639 (UMLS CUI [1,3])
C0200345 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
C0008000 (UMLS CUI [1,2])
C0018941 (UMLS CUI [2])
C0200345 (UMLS CUI [1,2])
C1264639 (UMLS CUI [1,3])
C0200345 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
C0422727 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C1549995 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,2])
C0008972 (UMLS CUI [1,2])