ID
41002
Beschreibung
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.
Stichworte
Versionen (1)
- 10.06.20 10.06.20 -
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
10. Juni 2020
DOI
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Lizenz
Creative Commons BY-NC 4.0
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Study of Casopitant Pharmacokinetics in Healthy Males, NKV103933
Demography
- StudyEvent: ODM
Beschreibung
Demography
Alias
- UMLS CUI-1
- C0011298
Beschreibung
Date of birth
Datentyp
date
Alias
- UMLS CUI [1]
- C0421451
Beschreibung
Only Male gender can be selected in this Form.
Datentyp
text
Alias
- UMLS CUI [1]
- C0079399
Beschreibung
• 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
Datentyp
integer
Alias
- UMLS CUI [1]
- C0015031
Beschreibung
Race - Tick all that apply
Alias
- UMLS CUI-1
- C0034510
Beschreibung
African American/African Heritage
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0085756
- UMLS CUI [2]
- C0027567
Beschreibung
American Indian or Alaskan Native
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1515945
Beschreibung
Central/South Asian Heritage
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0238696
- UMLS CUI [2]
- C1519427
Beschreibung
East Asian Heritage
Datentyp
boolean
Alias
- UMLS CUI [1]
- C4540996
Beschreibung
Japanese Heritage
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1556094
Beschreibung
South East Asian Heritage
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0238697
Beschreibung
Native Hawaiian or Other Pacific Islander
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1513907
Beschreibung
Arabic/North African Heritage
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0238604
- UMLS CUI [1,2]
- C2698217
Beschreibung
Caucasians
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0043157
Ähnliche Modelle
Demography
- StudyEvent: ODM
C0019994 (UMLS CUI [1,2])
C0027567 (UMLS CUI [2])
C1519427 (UMLS CUI [2])
C2698217 (UMLS CUI [1,2])