ID
37667
Description
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
Mots-clés
Versions (4)
- 12/08/2019 12/08/2019 -
- 14/08/2019 14/08/2019 -
- 14/08/2019 14/08/2019 -
- 14/08/2019 14/08/2019 -
Détendeur de droits
GlaxoSmithKline
Téléchargé le
14 août 2019
DOI
Pour une demande vous connecter.
Licence
Creative Commons BY-NC 3.0
Modèle Commentaires :
Ici, vous pouvez faire des commentaires sur le modèle. À partir des bulles de texte, vous pouvez laisser des commentaires spécifiques sur les groupes Item et les Item.
Groupe Item commentaires pour :
Item commentaires pour :
Vous devez être connecté pour pouvoir télécharger des formulaires. Veuillez vous connecter ou s’inscrire gratuitement.
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
Description
12-Lead/ Holter/ Telemetry ECG
Alias
- UMLS CUI-1
- C0430456
- UMLS CUI-2
- C0013801
- UMLS CUI-3
- C1623258
- UMLS CUI-4
- C0039451
Description
Date and Time of ECG
Type de données
datetime
Alias
- UMLS CUI [1]
- C2826846
Description
Heart rate
Type de données
integer
Unités de mesure
- beats/min
Alias
- UMLS CUI [1]
- C0018810
Description
PR lnterval
Type de données
integer
Unités de mesure
- ms
Alias
- UMLS CUI [1]
- C0429087
Description
QRS Duration
Type de données
integer
Unités de mesure
- ms
Alias
- UMLS CUI [1]
- C0429025
Description
Uncorrected QT lnterval
Type de données
integer
Unités de mesure
- ms
Alias
- UMLS CUI [1]
- C1287082
Description
QTc Interval
Type de données
integer
Alias
- UMLS CUI [1]
- C0489625
Description
Method of QTc Calculation
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0855331
- UMLS CUI [1,2]
- C2911685
Description
Result of the ECG
Type de données
integer
Alias
- UMLS CUI [1]
- C0438154
Description
12-Lead ECG Abnormalities
Alias
- UMLS CUI-1
- C0430456
- UMLS CUI-2
- C1704258
Description
Date and Time of ECG
Type de données
datetime
Alias
- UMLS CUI [1]
- C2826846
Description
Record clinically significant abnormalities
Type de données
text
Alias
- UMLS CUI [1]
- C0232187
Description
A. If other abnormal rhythm, enter comment
Type de données
text
Alias
- UMLS CUI [1,1]
- C0232187
- UMLS CUI [1,2]
- C0205161
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [1,4]
- C0947611
Description
Record clinically significant abnormalities
Type de données
text
Alias
- UMLS CUI [1]
- C2216025
Description
B. If other morphology, enter comment
Type de données
text
Alias
- UMLS CUI [1,1]
- C0332437
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C0947611
Description
C. Conduction
Type de données
text
Alias
- UMLS CUI [1]
- C0232217
Description
C. If other conduction, enter comment
Type de données
text
Alias
- UMLS CUI [1,1]
- C0232217
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C0947611
Description
D. Myocardial Infarction
Type de données
text
Alias
- UMLS CUI [1]
- C0027051
Description
D. If other myocardial infarction, enter comment
Type de données
text
Alias
- UMLS CUI [1,1]
- C0027051
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C0947611
Description
E. Depolarisation/Repolarisation (QRS-T)
Type de données
text
Alias
- UMLS CUI [1]
- C1395184
- UMLS CUI [2]
- C0948857
Description
E. If other depolarisation/ repolarisation, enter comment
Type de données
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
Description
If other abnormalities, enter comment
Type de données
text
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1704258
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [1,4]
- C0947611
Description
Electronically Transferred Lab Data
Alias
- UMLS CUI-1
- C0745590
- UMLS CUI-2
- C1705822
Description
Haematology Date and time sample taken
Type de données
datetime
Alias
- UMLS CUI [1,1]
- C0018941
- UMLS CUI [1,2]
- C0870078
- UMLS CUI [1,3]
- C0011008
- UMLS CUI [1,4]
- C0040223
Description
Haematology sample not taken
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0018941
- UMLS CUI [1,2]
- C0200345
- UMLS CUI [1,3]
- C1272696
Description
Clinical Chemistry Date and time sample taken
Type de données
datetime
Alias
- UMLS CUI [1,1]
- C0008000
- UMLS CUI [1,2]
- C0200345
- UMLS CUI [1,3]
- C1264639
Description
Clinical Chemistry sample not taken
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0008000
- UMLS CUI [1,2]
- C0200345
- UMLS CUI [1,3]
- C1272696
Description
Clinical Chemistry same as the Haematology sample
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0200345
- UMLS CUI [1,2]
- C0008000
- UMLS CUI [2]
- C0018941
Description
Urinalysis Date and time sample taken
Type de données
datetime
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C0200345
- UMLS CUI [1,3]
- C1264639
Description
Urinalysis sample not taken.
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C0200345
- UMLS CUI [1,3]
- C1272696
Description
Subject Identification
Alias
- UMLS CUI-1
- C2348585
Similar models
Screen - 12-Lead/ Holter/ Telemetry ECG; 21-Lead ECG Abnormalities
C2985720 (UMLS CUI-2)
C2985720 (UMLS CUI [1,2])
C0013801 (UMLS CUI-2)
C1623258 (UMLS CUI-3)
C0039451 (UMLS CUI-4)
C2911685 (UMLS CUI [1,2])
C1704258 (UMLS CUI-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])