ID
36012
Beskrivning
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/ Cardiovascular Monitoring form. It has to be filled in for screening and follow-up.
Nyckelord
Versioner (1)
- 2019-04-09 2019-04-09 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
9 april 2019
DOI
För en begäran logga in.
Licens
Creative Commons BY-NC 3.0
Modellkommentarer :
Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.
Itemgroup-kommentar för :
Item-kommentar för :
Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.
Comparison of pharmacokinetic and tolerability of ropinirole in healthy adults, 101468/198
Electrocardiography/ Cardiovascular Monitoring for Screening and Follow-up
Beskrivning
12 LEAD ECG
Alias
- UMLS CUI-1
- C0430456
Beskrivning
00:00-23:59
Datatyp
time
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1301880
Beskrivning
Heart rate
Datatyp
integer
Måttenheter
- bpm
Alias
- UMLS CUI [1]
- C0018810
Beskrivning
PR interval
Datatyp
integer
Måttenheter
- msec
Alias
- UMLS CUI [1]
- C0429087
Beskrivning
QRS duration
Datatyp
integer
Måttenheter
- msec
Alias
- UMLS CUI [1]
- C0429025
Beskrivning
QT duration
Datatyp
integer
Måttenheter
- msec
Alias
- UMLS CUI [1]
- C1880452
Beskrivning
QTc interval
Datatyp
integer
Måttenheter
- msec
Alias
- UMLS CUI [1]
- C0489625
Beskrivning
ECG normal
Datatyp
text
Alias
- UMLS CUI [1]
- C0522054
Beskrivning
Comments
Datatyp
text
Alias
- UMLS CUI [1]
- C0947611
Beskrivning
Blood pressure measurement
Alias
- UMLS CUI-1
- C0005823
Beskrivning
Body position
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1262869
- UMLS CUI [1,2]
- C0005823
Beskrivning
00:00-23:59
Datatyp
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0005823
Beskrivning
Systolic blood pressure
Datatyp
integer
Måttenheter
- mmHg
Alias
- UMLS CUI [1]
- C0871470
Beskrivning
Diastolic blood pressure
Datatyp
integer
Måttenheter
- mmHg
Alias
- UMLS CUI [1]
- C0428883
Beskrivning
Pulse
Datatyp
integer
Måttenheter
- bpm
Alias
- UMLS CUI [1]
- C0232117
Beskrivning
Comments
Datatyp
text
Alias
- UMLS CUI [1]
- C0947611
Similar models
Electrocardiography/ Cardiovascular Monitoring for Screening and Follow-up
C1301880 (UMLS CUI [1,2])
C0005823 (UMLS CUI [1,2])
Inga kommentarer