ID
37634
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 (4)
- 12-08-19 12-08-19 -
- 14-08-19 14-08-19 -
- 14-08-19 14-08-19 -
- 14-08-19 14-08-19 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
12 augustus 2019
DOI
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Licentie
Creative Commons BY-NC 3.0
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Pharmacokinetic characteristics, safety and tolerability of single oral doses of three prototype 300mg enteric coated - modified release formulations of Lamotrigine (Study ID: 105377)
Screen - 12-Lead/ Holter/ Telemetry ECG; 21-Lead ECG Abnormalities
Beschrijving
12-Lead ECG Abnormalities
Alias
- UMLS CUI-1
- C0430456
- UMLS CUI-2
- C1704258
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
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
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Screen - 12-Lead/ Holter/ Telemetry ECG; 21-Lead ECG Abnormalities
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