ID

32105

Descripción

This ODM file contains the form to record the pharmacokinetics. To be assessed at Day 1 of Period 1 and 2. Study ID: 106396 Clinical Study ID: TRX106396 Study Title: An open-label, randomized, single-dose, 2-period crossover study to evaluate sumatriptan pharmacokinetics for a TREXIMA™(sumatriptan 85mg and naproxen sodium 500mg)*, Tablet compared with an IMITREX® (sumatriptan) 100mg Tablet 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: sumatriptan Trade Name: Imitrex ,Imiject ,Imigran; Imitrex,Imiject,Imigran Study Indication: Migraine Disorders Sponsor: GlaxoSmithKline

Palabras clave

Versiones (2)
  1. 12/10/18 12/10/18 -
  2. 17/10/18 17/10/18 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

17 de octubre de 2018

DOI

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Licencia

Creative Commons BY-NC 3.0
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Sumatriptan pharmacokinetics TREXIMA and IMITREX tablet ID 106396

Inglés

Pharmacokinetics

1 formularios  
  1. StudyEvent: ODM
    1. Pharmacokinetics
Administrative Data
Descripción

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Identifier
Descripción

Subject Identifier

Tipo de datos

text

Alias
UMLS CUI [1]
C2348585
Visit Date
Descripción

Visit Date

Tipo de datos

date

Alias
UMLS CUI [1]
C1320303
Visit Type
Descripción

Visit Type

Tipo de datos

integer

Alias
UMLS CUI [1]
C0545082
Pharmacokinetics - Blood
Descripción

Pharmacokinetics - Blood

Alias
UMLS CUI-1
C0031328
UMLS CUI-2
C0005767
Planned Relative Time Time Relative to Dosing
Descripción

Time Relative to Dosing 1 48 and 72 hour PK samples only apply following TREXIMA administration. Sample number indicated in brackets; starting with 1... are the sample numbers in period 1, starting with 2... those in period 2.

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0439564
Scheduled Time
Descripción

Scheduled Time

Tipo de datos

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C1301732
Date sample taken
Descripción

Date sample taken

Tipo de datos

date

Alias
UMLS CUI [1]
C1302413
Actual time
Descripción

Actual time

Tipo de datos

time

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0040223
5 mL Sample Check if Taken
Descripción

Sample taken

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0200345
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Similar models

Pharmacokinetics

1 formularios
  1. StudyEvent: ODM
    1. Pharmacokinetics
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Subject Identifier
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item
Visit Type
integer
C0545082 (UMLS CUI [1])
Visit Type
Code List
Visit Type
CL Item
Day 1 of Period 1 (1)
CL Item
Day 1 of Period 2 (2)
Item Group
Pharmacokinetics - Blood
C0031328 (UMLS CUI-1)
C0005767 (UMLS CUI-2)
Item
Planned Relative Time Time Relative to Dosing
text
C0031328 (UMLS CUI [1,1])
C0439564 (UMLS CUI [1,2])
Planned Relative Time
Code List
Planned Relative Time Time Relative to Dosing
CL Item
Pre-Dose (101, 201) (1)
CL Item
5 minutes (102, 202) (2)
CL Item
10 minutes (103, 203) (3)
CL Item
15 minutes (104, 204) (4)
CL Item
20 minutes (105, 205) (5)
CL Item
25 minutes (106, 206) (6)
CL Item
30 minutes (107, 207) (7)
CL Item
40 minutes (108, 208) (8)
CL Item
50 minutes (109, 209) (9)
CL Item
60 minutes (110, 210) (10)
CL Item
75 minutes (111, 211) (11)
CL Item
90 minutes (112, 212) (12)
CL Item
2 hours (113, 213) (13)
CL Item
2.5 hours (114, 214) (14)
CL Item
3 hours (115, 215) (15)
CL Item
4 hours (116, 216) (16)
CL Item
6 hours (117, 217) (17)
CL Item
8 hours (118, 218) (18)
CL Item
10 hours (119, 219) (19)
CL Item
12 hours (120, 220) (20)
CL Item
16 hours (121, 221) (21)
CL Item
24 hours (122, 222) (22)
CL Item
48 hours1 (123, 223) (23)
CL Item
72 hours1 (124, 224) (24)
Scheduled Time
Item
Scheduled Time
time
C0040223 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
Date sample taken
Item
Date sample taken
date
C1302413 (UMLS CUI [1])
Actual time
Item
Actual time
time
C0031328 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Sample taken
Item
5 mL Sample Check if Taken
boolean
C0200345 (UMLS CUI [1])
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