ID
36013
Description
Study ID: 101468/198 Clinical Study ID: 101468/198 Study Title:An open, randomised, crossover, healthy volunteer study to compare the PK and tolerability of ropinirole as 3 different new formulations with the standard marketed formulation and to study the effects of a high fat meal on a new formulation 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: ropinirole Trade Name: Modutab,ZIPEREVE,ZEPREVE,REPREVE,ADARTREL,REQUIP,Zygara; Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL Study Indication : Restless Legs Syndrome The Study consists of a Screening, 5 Sessions each with 2 days and a Follow-up. This document contains the Electrocardiography form. It has to be filled in for all Sessions each for both Day 1 and Day 2.
Keywords
Versions (1)
- 4/9/19 4/9/19 -
Copyright Holder
GlaxoSmithKline
Uploaded on
April 9, 2019
DOI
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License
Creative Commons BY-NC 3.0
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Comparison of pharmacokinetic and tolerability of ropinirole in healthy adults, 101468/198
Electrocardiography
- StudyEvent: ODM
Description
12 LEAD ECG
Alias
- UMLS CUI-1
- C0430456
Description
Only for Day 1.
Data type
integer
Alias
- UMLS CUI [1,1]
- C0439564
- UMLS CUI [1,2]
- C1623258
Description
Only for Day 2.
Data type
integer
Alias
- UMLS CUI [1,1]
- C0439564
- UMLS CUI [1,2]
- C1623258
Description
00:00-23:59
Data type
time
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1301880
Description
heart rate
Data type
integer
Measurement units
- bpm
Alias
- UMLS CUI [1]
- C0018810
Description
PR interval
Data type
integer
Measurement units
- msec
Alias
- UMLS CUI [1]
- C0429087
Description
QRS duration
Data type
integer
Measurement units
- msec
Alias
- UMLS CUI [1]
- C0429025
Description
QT duration
Data type
integer
Measurement units
- msec
Alias
- UMLS CUI [1]
- C1880452
Description
QTc interval
Data type
integer
Measurement units
- msec
Alias
- UMLS CUI [1]
- C0489625
Description
ECG normal
Data type
text
Alias
- UMLS CUI [1]
- C0522054
Description
Comments
Data type
text
Alias
- UMLS CUI [1]
- C0947611
Similar models
Electrocardiography
- StudyEvent: ODM
C1623258 (UMLS CUI [1,2])
C1623258 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,2])
No comments