ID

40851

Beskrivning

Study ID: 103933 Clinical Study ID: NKV103933 Study Title: A non-randomised, open label, two period cross-over study to determine the excretion balance and metabolic disposition of [14C]-GW679769, administered as single doses of an oral solution and an intravenous infusion to healthy male subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier:N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: casopitant Trade Name: Rezonic,Zunrisa; Zunrisa,Rezonic Study Indication: Nausea and Vomiting, Chemotherapy-Induced Protocol ID: NKV103933 The eligibility to participate was determined during a screening visit within 21 days prior to first dosing day. The study consisted of two dosing periods, each consisting of predose visit, monitoring after dose administration and prior to discharge visit. Dosing periods were separated by a wash-out period of 43 days. This Form confirms the accuracy of data by the Investigator and provides further comments. It has to be filled after the Screening and after Subject's participation in the study has ended.

Nyckelord

  1. 2020-05-26 2020-05-26 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

26 maj 2020

DOI

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Licens

Creative Commons BY-NC 4.0

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Study of Casopitant Pharmacokinetics in Healthy Males, NKV103933

Investigator Comment Log, Investigator's Signature

Administrative Data
Beskrivning

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Identifier
Beskrivning

Subject Identifier

Datatyp

text

Alias
UMLS CUI [1]
C2348585
Date
Beskrivning

Date

Datatyp

date

Alias
UMLS CUI [1]
C0011008
Document Type
Beskrivning

Document Type

Datatyp

text

Alias
UMLS CUI [1]
C1547673
Investigator Comment Log
Beskrivning

Investigator Comment Log

Alias
UMLS CUI-1
C0008961
UMLS CUI-2
C0947611
CRF page number if applicable
Beskrivning

CRF page number

Datatyp

text

Alias
UMLS CUI [1,1]
C1704732
UMLS CUI [1,2]
C1516308
Comment
Beskrivning

Comment

Datatyp

text

Alias
UMLS CUI [1]
C0947611
Investigator's Signature
Beskrivning

Investigator's Signature

Alias
UMLS CUI-1
C2346576
Investigator's signature
Beskrivning

I confirm that I have reviewed the data in this Case Report Form for this subject. All information entered by myself or my colleagues is, to the best of my knowledge, complete and accurate, as of the date below.

Datatyp

text

Alias
UMLS CUI [1]
C2346576
Investigator's name (print)
Beskrivning

Investigator's name

Datatyp

text

Alias
UMLS CUI [1]
C2826892
Date
Beskrivning

Investigator's signature: Date

Datatyp

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008

Similar models

Investigator Comment Log, Investigator's Signature

Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Subject Identifier
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Item
Document Type
text
C1547673 (UMLS CUI [1])
Code List
Document Type
CL Item
Screening (Screening)
CL Item
End of Study (subject withdrawal or completion) (End of Study)
Item Group
Investigator Comment Log
C0008961 (UMLS CUI-1)
C0947611 (UMLS CUI-2)
CRF page number
Item
CRF page number if applicable
text
C1704732 (UMLS CUI [1,1])
C1516308 (UMLS CUI [1,2])
Comment
Item
Comment
text
C0947611 (UMLS CUI [1])
Item Group
Investigator's Signature
C2346576 (UMLS CUI-1)
Investigator's Signature
Item
Investigator's signature
text
C2346576 (UMLS CUI [1])
Investigator's name
Item
Investigator's name (print)
text
C2826892 (UMLS CUI [1])
Investigator's signature: Date
Item
Date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])

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