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

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Licentie

Creative Commons BY-NC 4.0
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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
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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])
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