ID

41730

Beschrijving

Study ID: 111582 Clinical Study ID: 111582 Study Title: An Open Label Study to Examine the Effects of Low-fat and High-fat Meals on the Pharmacokinetics of Orally Administered Lapatinib in Metastatic ErbB2 Positive Breast Cancer Patients. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00821054 https://clinicaltrials.gov/ct2/show/NCT00821054 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Lapatinib Trade Name: N/A Study Indication: Neoplasms, Breast The study consists of a screening, four study visits at day-1, week 1, 2 and 3 and a follow-up visit. Pharmacokinetics Blood measurements are supposed to be made ar the week 1, 2 and 3 visits.

Link

https://clinicaltrials.gov/ct2/show/NCT00821054

Trefwoorden

Versies (1)
  1. 09-01-21 09-01-21 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

9 januari 2021

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY-NC 4.0
Model Commentaren :

Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.

Terug naar het model Commentaren
Itemgroep Commentaren voor :

Item Commentaren voor :

  • Nieuwste
  • Oudste
  • Populair
  • Nieuwste
    • Nieuwste
    • Oudste
    • Populair

Geen commentaren

U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.

Effects of Low-fat and high-fat meals on the Pharmacokinetics of Lapatinib in ErB2+ Breast Cancer patients, NCT00821054

Engels

Pharmacokinetics, week 1, 2 and 3

1 Formulieren  
Administrative Data
Beschrijving

Administrative Data

Alias
UMLS CUI-1
C1320722
visit date
Beschrijving

date of visit

Datatype

date

Alias
UMLS CUI [1]
C1320303
subject ID
Beschrijving

subject ID

Datatype

text

Alias
UMLS CUI [1]
C2348585
visit type
Beschrijving

visit type

Datatype

text

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0332307
Dosing date and time
Beschrijving

Dosing date and time

Alias
UMLS CUI-1
C0178602
UMLS CUI-2
C1264639
Dosing date/time
Beschrijving

[read-only]

Datatype

datetime

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C1264639
predose
Beschrijving

please fill in the actual date/time

Datatype

datetime

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0439565
UMLS CUI [1,3]
C1264639
0.25 hours post dose
Beschrijving

please fill in the actual time

Datatype

time

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0439568
UMLS CUI [1,3]
C0040223
0.5 hours post dose
Beschrijving

please fill in the actual time

Datatype

time

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0439568
UMLS CUI [1,3]
C0040223
1 hour post dose
Beschrijving

please fill in the actual time

Datatype

time

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0439568
UMLS CUI [1,3]
C0040223
1.5 hours post dose
Beschrijving

please fill in the actual time

Datatype

time

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0439568
UMLS CUI [1,3]
C0040223
2 hours post dose
Beschrijving

please fill in the actual time

Datatype

time

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0439568
UMLS CUI [1,3]
C0040223
2.5 hours post dose
Beschrijving

please fill in the actual time

Datatype

time

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0439568
UMLS CUI [1,3]
C0040223
3 hours post dose
Beschrijving

please fill in the actual time

Datatype

time

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0439568
UMLS CUI [1,3]
C0040223
4 hours post dose
Beschrijving

please fill in the actual time

Datatype

time

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0439568
UMLS CUI [1,3]
C0040223
6 hours post dose
Beschrijving

please fill in the actual time

Datatype

time

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0439568
UMLS CUI [1,3]
C0040223
8 hours post dose
Beschrijving

please fill in the actual date/time

Datatype

datetime

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0439568
UMLS CUI [1,3]
C1264639
10 hours post dose
Beschrijving

please fill in the actual date/time

Datatype

datetime

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0439568
UMLS CUI [1,3]
C1264639
3 hours post dose
Beschrijving

please fill in the actual date/time

Datatype

datetime

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0439568
UMLS CUI [1,3]
C1264639
Terug naar het begin van de pagina

Similar models

Pharmacokinetics, week 1, 2 and 3

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
date of visit
Item
visit date
date
C1320303 (UMLS CUI [1])
subject ID
Item
subject ID
text
C2348585 (UMLS CUI [1])
Item
visit type
text
C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
visit type
Code List
visit type
CL Item
week 1 (1)
CL Item
week 2  (2)
CL Item
week 3 (3)
Item Group
Dosing date and time
C0178602 (UMLS CUI-1)
C1264639 (UMLS CUI-2)
Pharmacokinetics Dosing date/time
Item
Dosing date/time
datetime
C0031328 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1264639 (UMLS CUI [1,3])
Pharmacokinetics pre-dose date/time
Item
predose
datetime
C0031328 (UMLS CUI [1,1])
C0439565 (UMLS CUI [1,2])
C1264639 (UMLS CUI [1,3])
Pharmacokinetics 0.25 hours post dose, time
Item
0.25 hours post dose
time
C0031328 (UMLS CUI [1,1])
C0439568 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Pharmacokinetics 0.5 hours post dose, time
Item
0.5 hours post dose
time
C0031328 (UMLS CUI [1,1])
C0439568 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Pharmacokinetics 1 hour post dose, time
Item
1 hour post dose
time
C0031328 (UMLS CUI [1,1])
C0439568 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Pharmacokinetics 1.5 hours post dose, time
Item
1.5 hours post dose
time
C0031328 (UMLS CUI [1,1])
C0439568 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Pharmacokinetics 2 hours post dose, time
Item
2 hours post dose
time
C0031328 (UMLS CUI [1,1])
C0439568 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Pharmacokinetics 2.5 hours post dose, time
Item
2.5 hours post dose
time
C0031328 (UMLS CUI [1,1])
C0439568 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Pharmacokinetics 3 hours post dose, time
Item
3 hours post dose
time
C0031328 (UMLS CUI [1,1])
C0439568 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Pharmacokinetics 4 hours post dose, time
Item
4 hours post dose
time
C0031328 (UMLS CUI [1,1])
C0439568 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Pharmacokinetics 6 hours post dose, time
Item
6 hours post dose
time
C0031328 (UMLS CUI [1,1])
C0439568 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Pharmacokinetics 8 hours post dose date/time
Item
8 hours post dose
datetime
C0031328 (UMLS CUI [1,1])
C0439568 (UMLS CUI [1,2])
C1264639 (UMLS CUI [1,3])
Pharmacokinetics 10 hours post dose, date/time
Item
10 hours post dose
datetime
C0031328 (UMLS CUI [1,1])
C0439568 (UMLS CUI [1,2])
C1264639 (UMLS CUI [1,3])
Pharmacokinetics 24 hours post dose, date/time
Item
3 hours post dose
datetime
C0031328 (UMLS CUI [1,1])
C0439568 (UMLS CUI [1,2])
C1264639 (UMLS CUI [1,3])
Terug naar het begin van de pagina 

Contact

Gebruik dit formulier voor feedback, vragen en verbeteringsvoorstellen.

Velden gemarkeerd met een * zijn verplicht.

Help

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