ID
33048
Description
This form contains a form to document the randomisation number, investigational products and the pharmacokinetics. To be assessed at the visits V1-3. Study ID: 103629 Clinical Study ID: TRX103629 Study Title: An open-label, randomized, 3-period crossover study to evaluate sumatriptan and naproxen pharmacokinetics for a combination tablet product containing sumatriptan/naproxen sodium followed by IMITREX™ (sumatriptan succinate) Injection 4mg administered using the IMITREX STATdose System and a sumatriptan/naproxen sodium tablet followed by IMITREX (sumatriptan succinate) Injection 6mg administered using the STATdose system compared with an IMITREX tablet 100mg followed by an IMITREX tablet 100mg Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00875784 Clinicaltrials.gov link: https://clinicaltrials.gov/ct2/show/NCT00875784 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
Lien
https://clinicaltrials.gov/ct2/show/NCT00875784
Mots-clés
Versions (3)
- 18/11/2018 18/11/2018 -
- 25/11/2018 25/11/2018 -
- 25/11/2018 25/11/2018 -
Détendeur de droits
GlaxoSmithKline
Téléchargé le
25 novembre 2018
DOI
Pour une demande vous connecter.
Licence
Creative Commons BY-NC 3.0
Modèle Commentaires :
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Sumatriptan pharmacokinetics for TREXIMA/IMITREX NCT00875784
Randomisation Number, Investigational Products, Pharmacokinetics Blood
Description
Randomisation Number (Only Visit 1)
Alias
- UMLS CUI-1
- C1300638
- UMLS CUI-2
- C0034656
Description
Subject's randomisation
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C1300638
- UMLS CUI [1,2]
- C0034656
Description
Randomisation number
Type de données
text
Alias
- UMLS CUI [1,1]
- C1300638
- UMLS CUI [1,2]
- C0034656
Description
Date of randomisation
Type de données
date
Alias
- UMLS CUI [1]
- C0034656
Description
Investigational Product
Alias
- UMLS CUI-1
- C0304229
Description
Treatment Confirmation
Alias
- UMLS CUI-1
- C0750484
- UMLS CUI-2
- C0087111
Description
Receivement of the correct treatment
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0750484
- UMLS CUI [1,2]
- C0087111
Description
Reason(s) in case the subject did not receive the correct treatment
Type de données
text
Alias
- UMLS CUI [1,1]
- C0087111
- UMLS CUI [1,2]
- C3827420
- UMLS CUI [1,3]
- C0392360
Description
Dosing Date and Time
Alias
- UMLS CUI-1
- C0178602
- UMLS CUI-2
- C1264639
Description
Pharmacokinetics Blood
Alias
- UMLS CUI-1
- C0031328
- UMLS CUI-2
- C0005767
Description
Planned relative time of blood sample collection for pharmacokinetics analysis
Type de données
text
Alias
- UMLS CUI [1,1]
- C0439564
- UMLS CUI [1,2]
- C0031328
- UMLS CUI [1,3]
- C0005834
Description
To be assessed for all timepoints up to 4 hours post-dose (included)
Type de données
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0031328
- UMLS CUI [1,3]
- C0005834
Description
To be assessed for all timepoints from 6 hours post-dose on (included).
Type de données
datetime
Alias
- UMLS CUI [1,1]
- C1264639
- UMLS CUI [1,2]
- C0031328
- UMLS CUI [1,3]
- C0005834
Similar models
Randomisation Number, Investigational Products, Pharmacokinetics Blood
C0034656 (UMLS CUI-2)
C0034656 (UMLS CUI [1,2])
C0034656 (UMLS CUI [1,2])
C1264639 (UMLS CUI [1,2])
C0087111 (UMLS CUI-2)
C0087111 (UMLS CUI [1,2])
C3827420 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
C1264639 (UMLS CUI [1,2])
C0005767 (UMLS CUI-2)
C0031328 (UMLS CUI [1,2])
C0005834 (UMLS CUI [1,3])
C0031328 (UMLS CUI [1,2])
C0005834 (UMLS CUI [1,3])
C0031328 (UMLS CUI [1,2])
C0005834 (UMLS CUI [1,3])