ID

25484

Description

Study ID: 101468/197 Clinical Study ID: SKF-101468/197 Study Title:An open study to compare the PK and tolerability of ropinirole administered as 5 different new formulations with the standard, marketed formulation in healthy volunteers 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: Requip Study Indication : Restless Legs Syndrome

Mots-clés

Versions (3)
  1. 04/09/2017 04/09/2017 -
  2. 04/09/2017 04/09/2017 -
  3. 05/09/2017 05/09/2017 -
Détendeur de droits

GlaxoSmithKline

Téléchargé le

4 septembre 2017

DOI

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Licence

Creative Commons BY-NC 3.0
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screening physical examination PK and tolerability of ropinirole as 5 new formulations 101468/197

Anglais

screening physical examination PK and tolerability of ropinirole as 5 new formulations 101468/197

1 Formulaires  
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Focus Panel ID
Description

focus panel

Type de données

integer

Alias
UMLS CUI [1]
C3846158
Patient No
Description

patient number

Type de données

integer

Alias
UMLS CUI [1]
C1830427
Date
Description

date

Type de données

date

Alias
UMLS CUI [1]
C0011008
Body area
Description

Body area

Alias
UMLS CUI-1
C1268086
Eyes, ears, nose, mouth, throat
Description

eyes, ears, nose, mouth, throat

Type de données

text

Alias
UMLS CUI [1]
C0015392
UMLS CUI [2]
C0013443
UMLS CUI [3]
C0028429
UMLS CUI [4]
C0230028
UMLS CUI [5]
C0031354
Eyes, ears, nose, mouth, throat
Description

Description of abnormality

Type de données

text

Alias
UMLS CUI [1]
C0015392
UMLS CUI [2]
C0013443
UMLS CUI [3]
C0028429
UMLS CUI [4]
C0230028
UMLS CUI [5]
C0031354
Neck/Thyroid
Description

neck, thyroid

Type de données

text

Alias
UMLS CUI [1]
C0027530
UMLS CUI [2]
C0040132
Neck/Thyroid
Description

Description of abnormality

Type de données

text

Alias
UMLS CUI [1]
C0027530
UMLS CUI [2]
C0040132
Spine
Description

spine

Type de données

text

Alias
UMLS CUI [1]
C0037949
Spine
Description

Description of abnormality

Type de données

text

Alias
UMLS CUI [1]
C0037949
Chest/lungs
Description

chest, lungs

Type de données

text

Alias
UMLS CUI [1]
C0817096
UMLS CUI [2]
C0024109
Chest/lungs
Description

Description of abnormality.

Type de données

text

Alias
UMLS CUI [1]
C0817096
UMLS CUI [2]
C0024109
Heart
Description

heart

Type de données

text

Alias
UMLS CUI [1]
C0018787
Heart
Description

Description of abnormality.

Type de données

text

Alias
UMLS CUI [1]
C0018787
Vascular system
Description

vascular system

Type de données

text

Alias
UMLS CUI [1]
C0489903
Vascular system
Description

Description of abnormality.

Type de données

text

Alias
UMLS CUI [1]
C0489903
Lymph nodes
Description

lymph nodes

Type de données

text

Alias
UMLS CUI [1]
C0024204
Lymph nodes
Description

Description of abnormality.

Type de données

text

Alias
UMLS CUI [1]
C0024204
Abdomen
Description

abdomen

Type de données

text

Alias
UMLS CUI [1]
C0000726
Abdomen
Description

Description of abnormality.

Type de données

text

Alias
UMLS CUI [1]
C0000726
Extremities
Description

extremities

Type de données

text

Alias
UMLS CUI [1]
C0436150
Extremities
Description

Description of abnormality.

Type de données

text

Alias
UMLS CUI [1]
C0436150
Nervous system/ reflexes
Description

nervous system, reflexes

Type de données

text

Alias
UMLS CUI [1]
C0027763
UMLS CUI [2]
C0034929
Nervous system/ reflexes
Description

Description of abnormality.

Type de données

text

Alias
UMLS CUI [1]
C0027763
UMLS CUI [2]
C0034929
Skin
Description

skin

Type de données

text

Alias
UMLS CUI [1]
C1123023
Skin
Description

Description of abnormality.

Type de données

text

Alias
UMLS CUI [1]
C1123023
Musculoskeletal system
Description

musculoskeletal system

Type de données

text

Alias
UMLS CUI [1]
C0026860
Musculoskeletal system
Description

Description of abnormality.

Type de données

text

Alias
UMLS CUI [1]
C0026860
Investigator
Description

Investigator

Alias
UMLS CUI-1
C2826892
Investigator's signature
Description

investigator's signature

Type de données

text

Alias
UMLS CUI [1]
C2346576
Date
Description

date

Type de données

date

Alias
UMLS CUI [1]
C0011008
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Similar models

screening physical examination PK and tolerability of ropinirole as 5 new formulations 101468/197

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
focus panel
Item
Focus Panel ID
integer
C3846158 (UMLS CUI [1])
patient number
Item
Patient No
integer
C1830427 (UMLS CUI [1])
date
Item
Date
date
C0011008 (UMLS CUI [1])
Item Group
Body area
C1268086 (UMLS CUI-1)
Item
Eyes, ears, nose, mouth, throat
text
C0015392 (UMLS CUI [1])
C0013443 (UMLS CUI [2])
C0028429 (UMLS CUI [3])
C0230028 (UMLS CUI [4])
C0031354 (UMLS CUI [5])
eyes, ears, nose, mouth, throat
Code List
Eyes, ears, nose, mouth, throat
CL Item
Normal  (Normal)
CL Item
Abnormal/Pathological (Abnormal/Pathological)
CL Item
Not examined (Not examined)
eyes, ears, nose, mouth, throat
Item
Eyes, ears, nose, mouth, throat
text
C0015392 (UMLS CUI [1])
C0013443 (UMLS CUI [2])
C0028429 (UMLS CUI [3])
C0230028 (UMLS CUI [4])
C0031354 (UMLS CUI [5])
Item
Neck/Thyroid
text
C0027530 (UMLS CUI [1])
C0040132 (UMLS CUI [2])
eyes, ears, nose, mouth, throat
Code List
Neck/Thyroid
CL Item
Normal  (Normal)
CL Item
Abnormal/Pathological (Abnormal/Pathological)
CL Item
Not examined (Not examined)
neck, thyroid
Item
Neck/Thyroid
text
C0027530 (UMLS CUI [1])
C0040132 (UMLS CUI [2])
Item
Spine
text
C0037949 (UMLS CUI [1])
eyes, ears, nose, mouth, throat
Code List
Spine
CL Item
Normal  (Normal)
CL Item
Abnormal/Pathological (Abnormal/Pathological)
CL Item
Not examined (Not examined)
spine
Item
Spine
text
C0037949 (UMLS CUI [1])
Item
Chest/lungs
text
C0817096 (UMLS CUI [1])
C0024109 (UMLS CUI [2])
eyes, ears, nose, mouth, throat
Code List
Chest/lungs
CL Item
Normal  (Normal)
CL Item
Abnormal/Pathological (Abnormal/Pathological)
CL Item
Not examined (Not examined)
Item
Chest/lungs
text
C0817096 (UMLS CUI [1])
C0024109 (UMLS CUI [2])
eyes, ears, nose, mouth, throat
Code List
Chest/lungs
Item
Heart
text
C0018787 (UMLS CUI [1])
eyes, ears, nose, mouth, throat
Code List
Heart
CL Item
Normal  (Normal)
CL Item
Abnormal/Pathological (Abnormal/Pathological)
CL Item
Not examined (Not examined)
heart
Item
Heart
text
C0018787 (UMLS CUI [1])
Item
Vascular system
text
C0489903 (UMLS CUI [1])
eyes, ears, nose, mouth, throat
Code List
Vascular system
CL Item
Normal  (Normal)
CL Item
Abnormal/Pathological (Abnormal/Pathological)
CL Item
Not examined (Not examined)
vascular system
Item
Vascular system
text
C0489903 (UMLS CUI [1])
Item
Lymph nodes
text
C0024204 (UMLS CUI [1])
eyes, ears, nose, mouth, throat
Code List
Lymph nodes
CL Item
Normal  (Normal)
CL Item
Abnormal/Pathological (Abnormal/Pathological)
CL Item
Not examined (Not examined)
lymph nodes
Item
Lymph nodes
text
C0024204 (UMLS CUI [1])
Item
Abdomen
text
C0000726 (UMLS CUI [1])
eyes, ears, nose, mouth, throat
Code List
Abdomen
CL Item
Normal  (Normal)
CL Item
Abnormal/Pathological (Abnormal/Pathological)
CL Item
Not examined (Not examined)
abdomen
Item
Abdomen
text
C0000726 (UMLS CUI [1])
Item
Extremities
text
C0436150 (UMLS CUI [1])
eyes, ears, nose, mouth, throat
Code List
Extremities
CL Item
Normal  (Normal)
CL Item
Abnormal/Pathological (Abnormal/Pathological)
CL Item
Not examined (Not examined)
extremities
Item
Extremities
text
C0436150 (UMLS CUI [1])
Item
Nervous system/ reflexes
text
C0027763 (UMLS CUI [1])
C0034929 (UMLS CUI [2])
eyes, ears, nose, mouth, throat
Code List
Nervous system/ reflexes
CL Item
Normal  (Normal)
CL Item
Abnormal/Pathological (Abnormal/Pathological)
CL Item
Not examined (Not examined)
nervous system, reflexes
Item
Nervous system/ reflexes
text
C0027763 (UMLS CUI [1])
C0034929 (UMLS CUI [2])
Item
Skin
text
C1123023 (UMLS CUI [1])
eyes, ears, nose, mouth, throat
Code List
Skin
CL Item
Normal  (Normal)
CL Item
Abnormal/Pathological (Abnormal/Pathological)
CL Item
Not examined (Not examined)
Item
Skin
text
C1123023 (UMLS CUI [1])
eyes, ears, nose, mouth, throat
Code List
Skin
Item
Musculoskeletal system
text
C0026860 (UMLS CUI [1])
eyes, ears, nose, mouth, throat
Code List
Musculoskeletal system
CL Item
Normal  (Normal)
CL Item
Abnormal/Pathological (Abnormal/Pathological)
CL Item
Not examined (Not examined)
musculoskeletal system
Item
Musculoskeletal system
text
C0026860 (UMLS CUI [1])
Item Group
Investigator
C2826892 (UMLS CUI-1)
investigator's signature
Item
Investigator's signature
text
C2346576 (UMLS CUI [1])
date
Item
Date
date
C0011008 (UMLS CUI [1])
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