ID

24394

Description

Study ID: 100716 Clinical Study ID: NKP100716 Study Title: An open label repeat dose study to investigate the effect of GW597599 (15 mg) and paroxetine (10 mg) given in combination for 15 days on the pharmacokinetics of midazolam and dextromethorphan in healthy male and female 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: vestipitant Trade Name: paroxetine and vestipitant Study Indication: Depressive Disorder and Anxiety Disorders Documentation part: Treatment Period 2 Dosing Details 13-17, PK Sampling 3-5

Mots-clés

Versions (1)
  1. 30/07/2017 30/07/2017 -
Détendeur de droits

GlaxoSmithKline

Téléchargé le

30 juillet 2017

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY-NC 3.0
Modèle Commentaires :

Ici, vous pouvez faire des commentaires sur le modèle. À partir des bulles de texte, vous pouvez laisser des commentaires spécifiques sur les groupes Item et les Item.

Retour au modèle Commentaires
Groupe Item commentaires pour :

Item commentaires pour :

Vous devez être connecté pour pouvoir télécharger des formulaires. Veuillez vous connecter ou s’inscrire gratuitement.

GW597599 and paroxetine on the pharmacokinetics of midazolam and dextromethorphan 100716 Treatment Period 2 Dosing Details 13-17, PK Sampling 3-5

Anglais

GW597599 and paroxetine on the pharmacokinetics of midazolam and dextromethorphan 100716 Treatment Period 2 Dosing Details 13-17, PK Sampling 3-5

1 Formulaires  
Dosing Details
Description

Dosing Details

Alias
UMLS CUI-1
C0013227
UMLS CUI-2
C0178602
Date and time of dosing GW597599
Description

dosing date and time

Type de données

datetime

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C0040223
Dose checked and administered by:
Description

dose administered

Type de données

text

Alias
UMLS CUI [1]
C2348343
Dose checked and witnessed by:
Description

dose witnessed

Type de données

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0682356
PK Sampling
Description

PK Sampling

Alias
UMLS CUI-1
C0031327
Time relative to start of dose
Description

time since dose

Type de données

text

Alias
UMLS CUI [1]
C0946444
Date
Description

pharmacokinetics date

Type de données

date

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0011008
Actual Time
Description

pharmacokinetics time

Type de données

time

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0040223
Sample Taken
Description

blood sample

Type de données

boolean

Alias
UMLS CUI [1]
C0005834
Comment
Description

pharmacokinetics comment

Type de données

text

Alias
UMLS CUI [1]
C0031328
Dosing Details
Description

Dosing Details

Alias
UMLS CUI-1
C0013227
UMLS CUI-2
C0178602
Date and time of dosing GW597599
Description

dosing date and time

Type de données

datetime

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C0040223
Dose checked and administered by:
Description

dose administered

Type de données

text

Alias
UMLS CUI [1]
C2348343
Dose checked and witnessed by:
Description

dose witnessed

Type de données

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0682356
Dosing Details
Description

Dosing Details

Alias
UMLS CUI-1
C0013227
UMLS CUI-2
C0178602
Date and time of dosing GW597599
Description

dosing date and time

Type de données

datetime

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C0040223
Dose checked and administered by:
Description

dose administered

Type de données

text

Alias
UMLS CUI [1]
C2348343
Dose checked and witnessed by:
Description

dose witnessed

Type de données

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0682356
Dosing Details
Description

Dosing Details

Alias
UMLS CUI-1
C0013227
UMLS CUI-2
C0178602
Date and time of dosing dextrometorphan
Description

dextrometorphan dosing date and time

Type de données

datetime

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C0040223
Dose checked and administered by:
Description

dose administered

Type de données

text

Alias
UMLS CUI [1]
C2348343
Dose checked and witnessed by:
Description

dose witnessed

Type de données

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0682356
Dosing Details
Description

Dosing Details

Alias
UMLS CUI-1
C0013227
UMLS CUI-2
C0178602
Date and time of dosing Midazolam
Description

midazolam dosing date and time

Type de données

datetime

Alias
UMLS CUI [1,1]
C0026056
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C0040223
Dose checked and administered by:
Description

dose administered

Type de données

text

Alias
UMLS CUI [1]
C2348343
Dose checked and witnessed by:
Description

dose witnessed

Type de données

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0682356
PK Sampling
Description

PK Sampling

Alias
UMLS CUI-1
C0031327
Time relative to start of dose
Description

time since dose

Type de données

text

Alias
UMLS CUI [1]
C0946444
Date
Description

pharmacokinetics date

Type de données

date

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0011008
Actual Time
Description

pharmacokinetics time

Type de données

time

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0040223
Sample Taken
Description

blood sample

Type de données

boolean

Alias
UMLS CUI [1]
C0005834
Comments
Description

pharmacokinetics comment

Type de données

text

Alias
UMLS CUI [1]
C0031328
PK Sampling
Description

PK Sampling

Alias
UMLS CUI-1
C0031327
Time relative to start of dose
Description

time since dose

Type de données

text

Alias
UMLS CUI [1]
C0946444
Date
Description

pharmacokinetics date

Type de données

date

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0011008
Actual Time
Description

pharmacokinetics time

Type de données

time

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0040223
Sample Taken
Description

blood sample

Type de données

boolean

Alias
UMLS CUI [1]
C0005834
Comments
Description

pharmacokinetics comment

Type de données

text

Alias
UMLS CUI [1]
C0031328
Retour au début de la page

Similar models

GW597599 and paroxetine on the pharmacokinetics of midazolam and dextromethorphan 100716 Treatment Period 2 Dosing Details 13-17, PK Sampling 3-5

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
Dosing Details
C0013227 (UMLS CUI-1)
C0178602 (UMLS CUI-2)
dosing date and time
Item
Date and time of dosing GW597599
datetime
C0013227 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
dose administered
Item
Dose checked and administered by:
text
C2348343 (UMLS CUI [1])
dose witnessed
Item
Dose checked and witnessed by:
text
C0013227 (UMLS CUI [1,1])
C0682356 (UMLS CUI [1,2])
Item Group
PK Sampling
C0031327 (UMLS CUI-1)
Item
Time relative to start of dose
text
C0946444 (UMLS CUI [1])
time since dose
Code List
Time relative to start of dose
CL Item
Pre-dose (Pre-dose)
CL Item
+1 hr (+1 hr)
CL Item
+2 hrs (+2 hrs)
CL Item
+3 hrs (+3 hrs)
CL Item
+5 hrs (+5 hrs)
CL Item
+8 hrs (+8 hrs)
CL Item
+12 hrs (+12 hrs)
CL Item
+16 hrs (+16 hrs)
CL Item
+24 hrs (+24 hrs)
pharmacokinetics date
Item
Date
date
C0031328 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
pharmacokinetics time
Item
Actual Time
time
C0031328 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
blood sample
Item
Sample Taken
boolean
C0005834 (UMLS CUI [1])
pharmacokinetics comment
Item
Comment
text
C0031328 (UMLS CUI [1])
Item Group
Dosing Details
C0013227 (UMLS CUI-1)
C0178602 (UMLS CUI-2)
dosing date and time
Item
Date and time of dosing GW597599
datetime
C0013227 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
dose administered
Item
Dose checked and administered by:
text
C2348343 (UMLS CUI [1])
dose witnessed
Item
Dose checked and witnessed by:
text
C0013227 (UMLS CUI [1,1])
C0682356 (UMLS CUI [1,2])
Item Group
Dosing Details
C0013227 (UMLS CUI-1)
C0178602 (UMLS CUI-2)
dosing date and time
Item
Date and time of dosing GW597599
datetime
C0013227 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
dose administered
Item
Dose checked and administered by:
text
C2348343 (UMLS CUI [1])
dose witnessed
Item
Dose checked and witnessed by:
text
C0013227 (UMLS CUI [1,1])
C0682356 (UMLS CUI [1,2])
Item Group
Dosing Details
C0013227 (UMLS CUI-1)
C0178602 (UMLS CUI-2)
dextrometorphan dosing date and time
Item
Date and time of dosing dextrometorphan
datetime
C0013227 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
dose administered
Item
Dose checked and administered by:
text
C2348343 (UMLS CUI [1])
dose witnessed
Item
Dose checked and witnessed by:
text
C0013227 (UMLS CUI [1,1])
C0682356 (UMLS CUI [1,2])
Item Group
Dosing Details
C0013227 (UMLS CUI-1)
C0178602 (UMLS CUI-2)
midazolam dosing date and time
Item
Date and time of dosing Midazolam
datetime
C0026056 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
dose administered
Item
Dose checked and administered by:
text
C2348343 (UMLS CUI [1])
dose witnessed
Item
Dose checked and witnessed by:
text
C0013227 (UMLS CUI [1,1])
C0682356 (UMLS CUI [1,2])
Item Group
PK Sampling
C0031327 (UMLS CUI-1)
Item
Time relative to start of dose
text
C0946444 (UMLS CUI [1])
time since dose
Code List
Time relative to start of dose
CL Item
Pre-dose (Pre-dose)
CL Item
+1 hr (+1 hr)
CL Item
+2 hrs (+2 hrs)
CL Item
+3 hrs (+3 hrs)
CL Item
+5 hrs (+5 hrs)
CL Item
+8 hrs (+8 hrs)
CL Item
+12 hrs (+12 hrs)
CL Item
+16 hrs (+16 hrs)
CL Item
+24 hrs (+24 hrs)
pharmacokinetics date
Item
Date
date
C0031328 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
pharmacokinetics time
Item
Actual Time
time
C0031328 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
blood sample
Item
Sample Taken
boolean
C0005834 (UMLS CUI [1])
pharmacokinetics comment
Item
Comments
text
C0031328 (UMLS CUI [1])
Item Group
PK Sampling
C0031327 (UMLS CUI-1)
Item
Time relative to start of dose
text
C0946444 (UMLS CUI [1])
time since dose
Code List
Time relative to start of dose
CL Item
Pre-dose (Pre-dose)
CL Item
+5 mins (+5 mins)
CL Item
+0.25 hr (+0.25 hr)
CL Item
+0.5 hr (+0.5 hr)
CL Item
+1 hr (+1 hr)
CL Item
+1.5 hrs (+1.5 hrs)
CL Item
+2 hrs (+2 hrs)
CL Item
+3 hrs (+3 hrs)
CL Item
+4 hrs (+4 hrs)
CL Item
+6 hrs (+6 hrs)
CL Item
+8 hrs (+8 hrs)
CL Item
+12 hrs (+12 hrs)
CL Item
+24 hrs (+24 hrs)
pharmacokinetics date
Item
Date
date
C0031328 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
pharmacokinetics time
Item
Actual Time
time
C0031328 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
blood sample
Item
Sample Taken
boolean
C0005834 (UMLS CUI [1])
pharmacokinetics comment
Item
Comments
text
C0031328 (UMLS CUI [1])
Retour au début de la page 

Contact

Utilisez ce formulaire pour les retours, les questions et les améliorations suggérées.

Les champs marqués d’un * sont obligatoires.

Aide

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