ID
41002
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 Demography Form has to be filled in at the Screening visit. Centre Number from Cover Sheets is included.
Mots-clés
Versions (1)
- 10/06/2020 10/06/2020 -
Détendeur de droits
GlaxoSmithKline
Téléchargé le
10 juin 2020
DOI
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Licence
Creative Commons BY-NC 4.0
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Study of Casopitant Pharmacokinetics in Healthy Males, NKV103933
Demography
- StudyEvent: ODM
Description
Demography
Alias
- UMLS CUI-1
- C0011298
Description
Date of birth
Type de données
date
Alias
- UMLS CUI [1]
- C0421451
Description
Only Male gender can be selected in this Form.
Type de données
text
Alias
- UMLS CUI [1]
- C0079399
Description
• Hispanic or Latino: A person of Cuban, Mexican, Puerto Rican, South American or other Spanish culture or origin, regardless of race Note: If the subject does not meet the definition above, tick Not Hispanic or Latino. • Not Hispanic or Latino: Neither Hispanic or Latino
Type de données
integer
Alias
- UMLS CUI [1]
- C0015031
Description
Race - Tick all that apply
Alias
- UMLS CUI-1
- C0034510
Description
African American/African Heritage
Type de données
boolean
Alias
- UMLS CUI [1]
- C0085756
- UMLS CUI [2]
- C0027567
Description
American Indian or Alaskan Native
Type de données
boolean
Alias
- UMLS CUI [1]
- C1515945
Description
Central/South Asian Heritage
Type de données
boolean
Alias
- UMLS CUI [1]
- C0238696
- UMLS CUI [2]
- C1519427
Description
East Asian Heritage
Type de données
boolean
Alias
- UMLS CUI [1]
- C4540996
Description
Japanese Heritage
Type de données
boolean
Alias
- UMLS CUI [1]
- C1556094
Description
South East Asian Heritage
Type de données
boolean
Alias
- UMLS CUI [1]
- C0238697
Description
Native Hawaiian or Other Pacific Islander
Type de données
boolean
Alias
- UMLS CUI [1]
- C1513907
Description
Arabic/North African Heritage
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0238604
- UMLS CUI [1,2]
- C2698217
Description
Caucasians
Type de données
boolean
Alias
- UMLS CUI [1]
- C0043157
Similar models
Demography
- StudyEvent: ODM
C0019994 (UMLS CUI [1,2])
C0027567 (UMLS CUI [2])
C1519427 (UMLS CUI [2])
C2698217 (UMLS CUI [1,2])