ID

32105

Description

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

Keywords

Versions (2)
  1. 10/12/18 10/12/18 -
  2. 10/17/18 10/17/18 -
Copyright Holder

GlaxoSmithKline

Uploaded on

October 17, 2018

DOI

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License

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

English

Pharmacokinetics

1 forms  
  1. StudyEvent: ODM
    1. Pharmacokinetics
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Identifier
Description

Subject Identifier

Data type

text

Alias
UMLS CUI [1]
C2348585
Visit Date
Description

Visit Date

Data type

date

Alias
UMLS CUI [1]
C1320303
Visit Type
Description

Visit Type

Data type

integer

Alias
UMLS CUI [1]
C0545082
Pharmacokinetics - Blood
Description

Pharmacokinetics - Blood

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

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.

Data type

text

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

Scheduled Time

Data type

time

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

Date sample taken

Data type

date

Alias
UMLS CUI [1]
C1302413
Actual time
Description

Actual time

Data type

time

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

Sample taken

Data type

boolean

Alias
UMLS CUI [1]
C0200345
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Similar models

Pharmacokinetics

1 forms
  1. StudyEvent: ODM
    1. Pharmacokinetics
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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