ID

36010

Descripción

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 Plasma Drug Assay fomr. It has to be filled in for all Sessions each for both Day 1 and Day 2.

Palabras clave

Versiones (1)
  1. 9/4/19 9/4/19 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

9 de abril de 2019

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY-NC 3.0
Comentarios del modelo :

Puede comentar sobre el modelo de datos aquí. A través de las burbujas de diálogo en los grupos de elementos y elementos, puede agregar comentarios específicos.

Volver a los comentarios del modelo
Comentarios de grupo de elementos para :

Comentarios del elemento para :

Para descargar modelos de datos, debe haber iniciado sesión. Por favor iniciar sesión o Registrate gratis.

Comparison of pharmacokinetic and tolerability of ropinirole in healthy adults, 101468/198

Inglés

Plasma Drug Assay

1 formularios  
  1. StudyEvent: ODM
    1. Plasma Drug Assay
Administrative data
Descripción

Administrative data

Alias
UMLS CUI-1
C1320722
Subject No.
Descripción

Subject No.

Tipo de datos

text

Alias
UMLS CUI [1]
C2348585
Panel ID
Descripción

Panel ID

Tipo de datos

text

Alias
UMLS CUI [1]
C3846158
Visit type
Descripción

Visit type

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0332307
Plasma Drug Assay
Descripción

Plasma Drug Assay

Alias
UMLS CUI-1
C1609077
UMLS CUI-2
C1261153
Date of dosing
Descripción

day month year

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C0011008
Time of dosing
Descripción

00:00-23:59

Tipo de datos

time

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C0040223
Time relative to start of dose, Day 1
Descripción

Only tick for Day 1.

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0439564
UMLS CUI [1,2]
C0178602
Time relative to start of dose, Day 2
Descripción

Only tick for Day 2.

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0439564
UMLS CUI [1,2]
C0178602
If different from visit date, please note Date of sample
Descripción

day month year

Tipo de datos

date

Alias
UMLS CUI [1]
C1302413
Actual time
Descripción

00:00-23:59

Tipo de datos

time

Alias
UMLS CUI [1]
C0040223
Blood samples taken for Plasma Assay?
Descripción

Blood samples taken

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1277698
UMLS CUI [1,2]
C1609077
Initials
Descripción

Initials

Tipo de datos

text

Alias
UMLS CUI [1]
C2986440
Comments
Descripción

Comments

Tipo de datos

text

Alias
UMLS CUI [1]
C0947611
Volver a la parte superior de la página

Similar models

Plasma Drug Assay

1 formularios
  1. StudyEvent: ODM
    1. Plasma Drug Assay
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Subject No.
Item
Subject No.
text
C2348585 (UMLS CUI [1])
Panel ID
Item
Panel ID
text
C3846158 (UMLS CUI [1])
Item
Visit type
integer
C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Visit type
Code List
Visit type
CL Item
Session 1 day 1 (1)
CL Item
Session 1 day 2 (2)
CL Item
Session 2 day 1  (3)
CL Item
Session 2 day 2 (4)
CL Item
Session 3 day 1 (5)
CL Item
Session 3 day 2 (6)
CL Item
Session 4 day 1 (7)
CL Item
Session 4 day 2 (8)
CL Item
Session 5 day 1 (9)
CL Item
Session 5 day 2 (10)
Item Group
Plasma Drug Assay
C1609077 (UMLS CUI-1)
C1261153 (UMLS CUI-2)
Date of dosing
Item
Date of dosing
date
C0178602 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Time of dosing
Item
Time of dosing
time
C0178602 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Item
Time relative to start of dose, Day 1
integer
C0439564 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
Relative time, Day 1
Code List
Time relative to start of dose, Day 1
CL Item
+15 min (1)
CL Item
+30 min (2)
CL Item
+45 min (3)
CL Item
+1 h (4)
CL Item
+2 h (5)
CL Item
+3 h (6)
CL Item
+4 h (7)
CL Item
+6 h (8)
Item
Time relative to start of dose, Day 2
integer
C0439564 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
Relative time, Day 1
Code List
Time relative to start of dose, Day 2
CL Item
+8 j (1)
CL Item
+10 h (2)
CL Item
+12 h (3)
CL Item
+14 h (4)
CL Item
+16 h (5)
CL Item
+24 h (6)
Sample Date
Item
If different from visit date, please note Date of sample
date
C1302413 (UMLS CUI [1])
Actual time
Item
Actual time
time
C0040223 (UMLS CUI [1])
Item
Blood samples taken for Plasma Assay?
text
C1277698 (UMLS CUI [1,1])
C1609077 (UMLS CUI [1,2])
Blood samples taken
Code List
Blood samples taken for Plasma Assay?
CL Item
Yes (Y)
CL Item
No (N)
Initials
Item
Initials
text
C2986440 (UMLS CUI [1])
Comments
Item
Comments
text
C0947611 (UMLS CUI [1])
Volver a la parte superior de la página 

Contacto

Utilice este formulario para comentarios, preguntas y sugerencias.

Los campos marcados con * son obligatorios.

Ayuda

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial