ID

41730

Description

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.

Lien

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

Mots-clés

Versions (1)
  1. 09/01/2021 09/01/2021 -
Détendeur de droits

GlaxoSmithKline

Téléchargé le

9 janvier 2021

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY-NC 4.0
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.

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

Anglais

Pharmacokinetics, week 1, 2 and 3

1 Formulaires  
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
visit date
Description

date of visit

Type de données

date

Alias
UMLS CUI [1]
C1320303
subject ID
Description

subject ID

Type de données

text

Alias
UMLS CUI [1]
C2348585
visit type
Description

visit type

Type de données

text

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

Dosing date and time

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

[read-only]

Type de données

datetime

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

please fill in the actual date/time

Type de données

datetime

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

please fill in the actual time

Type de données

time

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

please fill in the actual time

Type de données

time

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

please fill in the actual time

Type de données

time

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

please fill in the actual time

Type de données

time

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

please fill in the actual time

Type de données

time

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

please fill in the actual time

Type de données

time

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

please fill in the actual time

Type de données

time

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

please fill in the actual time

Type de données

time

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

please fill in the actual time

Type de données

time

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

please fill in the actual date/time

Type de données

datetime

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

please fill in the actual date/time

Type de données

datetime

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

please fill in the actual date/time

Type de données

datetime

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0439568
UMLS CUI [1,3]
C1264639
Retour au début de la page

Similar models

Pharmacokinetics, week 1, 2 and 3

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
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])
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