ID

40855

Descrição

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 Serology - HIC, Hepatitis B & C Screen Form has to be filled in at the Screening Visit.

Palavras-chave

  1. 26/05/2020 26/05/2020 -
Titular dos direitos

GlaxoSmithKline

Transferido a

26 de maio de 2020

DOI

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Licença

Creative Commons BY-NC 4.0

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Study of Casopitant Pharmacokinetics in Healthy Males, NKV103933

Serology - HIC, Hepatitis B & C Screen

Administrative Data
Descrição

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Identifier
Descrição

Subject Identifier

Tipo de dados

text

Alias
UMLS CUI [1]
C2348585
Visit Date
Descrição

Visit Date

Tipo de dados

date

Alias
UMLS CUI [1]
C1320303
Serology - HIC, Hepatitis B & C Screen
Descrição

Serology - HIC, Hepatitis B & C Screen

Alias
UMLS CUI-1
C0459958
UMLS CUI-2
C0036743
UMLS CUI-3
C0744837
UMLS CUI-4
C0850489
Date sample taken
Descrição

Date sample taken

Tipo de dados

date

Alias
UMLS CUI [1]
C1302413
HIV-1/-2
Descrição

If positive, exclude subject from the study.

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0036743
UMLS CUI [1,2]
C0459958
Hepatitis B surface antigen
Descrição

If positive, exclude subject from the study.

Tipo de dados

text

Alias
UMLS CUI [1]
C0019168
Hepatitis C antibody
Descrição

If positive, exclude subject from the study.

Tipo de dados

text

Alias
UMLS CUI [1]
C0201487

Similar models

Serology - HIC, Hepatitis B & C Screen

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
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 Group
Serology - HIC, Hepatitis B & C Screen
C0459958 (UMLS CUI-1)
C0036743 (UMLS CUI-2)
C0744837 (UMLS CUI-3)
C0850489 (UMLS CUI-4)
Date sample taken
Item
Date sample taken
date
C1302413 (UMLS CUI [1])
Item
HIV-1/-2
text
C0036743 (UMLS CUI [1,1])
C0459958 (UMLS CUI [1,2])
Code List
HIV-1/-2
CL Item
Positive (Positive)
CL Item
Negative (Negative)
Item
Hepatitis B surface antigen
text
C0019168 (UMLS CUI [1])
Code List
Hepatitis B surface antigen
CL Item
Positive (Positive)
CL Item
Negative (Negative)
Item
Hepatitis C antibody
text
C0201487 (UMLS CUI [1])
Code List
Hepatitis C antibody
CL Item
Positive (Positive)
CL Item
Negative (Negative)

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