ID

40799

Description

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. The Vital Signs Form has to be filled in at following visits: Screening, Treatment Period 1 Predose, Treatment Period 1 Prior to Discharge, Treatment Period 2 Predose, Treatment Period 2 Prior to Discharge, and whenever further assesments are done during the study (Unscheduled).

Mots-clés

  1. 15-05-20 15-05-20 -
Détendeur de droits

GlaxoSmithKline

Téléchargé le

15 mei 2020

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY-NC 4.0

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Study of Casopitant Pharmacokinetics in Healthy Males, NKV103933

Vital Signs

  1. StudyEvent: ODM
    1. Vital Signs
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Identifier
Description

Subject Identifier

Type de données

text

Alias
UMLS CUI [1]
C2348585
Visit Date
Description

Visit Date

Type de données

date

Alias
UMLS CUI [1]
C1320303
Visit Type
Description

Visit Type

Type de données

text

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0332307
Vital Signs
Description

Vital Signs

Alias
UMLS CUI-1
C0518766
Date
Description

Vital Signs; Date

Type de données

date

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0011008
Time
Description

Vital Signs; Time

Type de données

time

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0040223
Systolic Blood Pressure
Description

Blood Pressure Systolic

Type de données

integer

Unités de mesure
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Diastolic Blood Pressure
Description

Blood Pressure Diastolic

Type de données

integer

Unités de mesure
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Heart rate
Description

Heart Rate

Type de données

integer

Unités de mesure
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
Position
Description

To be filled in only at screening visit. First measurement in semi-supine position, second measurement in standing position. Body position should be semi-supine at all other visits.

Type de données

text

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C1262869

Similar models

Vital Signs

  1. StudyEvent: ODM
    1. Vital Signs
Name
Type
Description | Question | Decode (Coded Value)
Type de données
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
text
C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Code List
Visit Type
CL Item
Screening (Screening)
(Comment:en)
CL Item
Treatment Period 1 Predose (Treatment Period 1 Predose)
(Comment:en)
CL Item
Treatment Period 1 Prior to Discharge (Treatment Period 1 Prior to Discharge)
(Comment:en)
CL Item
Treatment Period 2 Predose (Treatment Period 2 Predose)
(Comment:en)
CL Item
Treatment Period 2 Prior to Discharge (Treatment Period 2 Prior to Discharge)
(Comment:en)
Item Group
Vital Signs
C0518766 (UMLS CUI-1)
Vital Signs; Date
Item
Date
date
C0518766 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Vital Signs; Time
Item
Time
time
C0518766 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Blood Pressure Systolic
Item
Systolic Blood Pressure
integer
C0871470 (UMLS CUI [1])
Blood Pressure Diastolic
Item
Diastolic Blood Pressure
integer
C0428883 (UMLS CUI [1])
Heart Rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Item
Position
text
C0518766 (UMLS CUI [1,1])
C1262869 (UMLS CUI [1,2])
Code List
Position
CL Item
Semi-supine (Semi-supine)
(Comment:en)
CL Item
Standing (Standing)
(Comment:en)

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