Informações:
Falhas:
ID
24394
Descrição
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
Palavras-chave
Versões (1)
- 30/07/2017 30/07/2017 -
Titular dos direitos
GlaxoSmithKline
Transferido a
30 de julho de 2017
DOI
Para um pedido faça login.
Licença
Creative Commons BY-NC 3.0
Comentários do modelo :
Aqui pode comentar o modelo. Pode comentá-lo especificamente através dos balões de texto nos grupos de itens e itens.
Comentários do grupo de itens para :
Comentários do item para :
Para descarregar formulários, precisa de ter uma sessão iniciada. Por favor faça login ou registe-se gratuitamente.
GW597599 and paroxetine on the pharmacokinetics of midazolam and dextromethorphan 100716 Treatment Period 2 Dosing Details 13-17, PK Sampling 3-5
GW597599 and paroxetine on the pharmacokinetics of midazolam and dextromethorphan 100716 Treatment Period 2 Dosing Details 13-17, PK Sampling 3-5
Similar models
GW597599 and paroxetine on the pharmacokinetics of midazolam and dextromethorphan 100716 Treatment Period 2 Dosing Details 13-17, PK Sampling 3-5
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
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])
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])
C0682356 (UMLS CUI [1,2])
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])
C0011008 (UMLS CUI [1,2])
pharmacokinetics time
Item
Actual Time
time
C0031328 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
blood sample
Item
Sample Taken
boolean
C0005834 (UMLS CUI [1])
pharmacokinetics comment
Item
Comment
text
C0031328 (UMLS CUI [1])
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])
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])
C0682356 (UMLS CUI [1,2])
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])
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])
C0682356 (UMLS CUI [1,2])
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])
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])
C0682356 (UMLS CUI [1,2])
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])
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])
C0682356 (UMLS CUI [1,2])
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])
C0011008 (UMLS CUI [1,2])
pharmacokinetics time
Item
Actual Time
time
C0031328 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
blood sample
Item
Sample Taken
boolean
C0005834 (UMLS CUI [1])
pharmacokinetics comment
Item
Comments
text
C0031328 (UMLS CUI [1])
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])
C0011008 (UMLS CUI [1,2])
pharmacokinetics time
Item
Actual Time
time
C0031328 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
blood sample
Item
Sample Taken
boolean
C0005834 (UMLS CUI [1])
pharmacokinetics comment
Item
Comments
text
C0031328 (UMLS CUI [1])