ID
36906
Descripción
Study ID: 101468/201 Clinical Study ID: 101468/201 Study Title: A Single Blind, Parallel Group, Up-titration, Phase 1 Study in Healthy Volunteers to Determine a Starting Dose and Select an Up-titration Regimen for a new Formulation of Ropinirole 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 21 Visits(Days): Screening (at least 21 days before dosing) Week 1: including Day 1-7 Week 2: including Day 8-14 Week 3: including Day 15-19 Follow-up Visit (7-14 days after last dose) This document contains the Pharmacokinetic sampling form. It has to befilled in for Day 1, Day 6, Day 12 and Day 19.
Palabras clave
Versiones (2)
- 2/9/17 2/9/17 -
- 21/6/19 21/6/19 -
Titular de derechos de autor
GlaxoSmithKline
Subido en
21 de junio de 2019
DOI
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Licencia
Creative Commons BY-NC 3.0
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Determination of starting dose and up-titration regimen for a new formulation of Ropinirole in healthy adults, 101468/201
PK Sampling
- StudyEvent: ODM
Descripción
PK SAMPLING
Alias
- UMLS CUI-1
- C0022877
Descripción
Time relative to start of dose
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0439564
- UMLS CUI [1,2]
- C1301880
- UMLS CUI [1,3]
- C0178602
Descripción
day month year The date has to be filled in for Pre-dose, +8 hrs and +10 hrs. If required you can also fill in the date for the other times.
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C0808070
- UMLS CUI [1,2]
- C0178602
Descripción
00:00-23:59
Tipo de datos
time
Alias
- UMLS CUI [1]
- C0040223
Descripción
Sample taken
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0200345
Descripción
Comments
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0947611
Similar models
PK Sampling
- StudyEvent: ODM
C1301880 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
C0178602 (UMLS CUI [1,2])