ID
41002
Beschrijving
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.
Trefwoorden
Versies (1)
- 10-06-20 10-06-20 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
10 juni 2020
DOI
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Licentie
Creative Commons BY-NC 4.0
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Study of Casopitant Pharmacokinetics in Healthy Males, NKV103933
Demography
- StudyEvent: ODM
Beschrijving
Demography
Alias
- UMLS CUI-1
- C0011298
Beschrijving
Date of birth
Datatype
date
Alias
- UMLS CUI [1]
- C0421451
Beschrijving
Only Male gender can be selected in this Form.
Datatype
text
Alias
- UMLS CUI [1]
- C0079399
Beschrijving
• 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
Datatype
integer
Alias
- UMLS CUI [1]
- C0015031
Beschrijving
Race - Tick all that apply
Alias
- UMLS CUI-1
- C0034510
Beschrijving
African American/African Heritage
Datatype
boolean
Alias
- UMLS CUI [1]
- C0085756
- UMLS CUI [2]
- C0027567
Beschrijving
American Indian or Alaskan Native
Datatype
boolean
Alias
- UMLS CUI [1]
- C1515945
Beschrijving
Central/South Asian Heritage
Datatype
boolean
Alias
- UMLS CUI [1]
- C0238696
- UMLS CUI [2]
- C1519427
Beschrijving
East Asian Heritage
Datatype
boolean
Alias
- UMLS CUI [1]
- C4540996
Beschrijving
Japanese Heritage
Datatype
boolean
Alias
- UMLS CUI [1]
- C1556094
Beschrijving
South East Asian Heritage
Datatype
boolean
Alias
- UMLS CUI [1]
- C0238697
Beschrijving
Native Hawaiian or Other Pacific Islander
Datatype
boolean
Alias
- UMLS CUI [1]
- C1513907
Beschrijving
Arabic/North African Heritage
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0238604
- UMLS CUI [1,2]
- C2698217
Beschrijving
Caucasians
Datatype
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])