ID
40798
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 Continuous 12-Lead ECG Form has to be filled in during Treatment Period 1.
Trefwoorden
Versies (1)
- 15/05/2020 15/05/2020 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
15 mai 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
Continuous 12-Lead ECG
- StudyEvent: ODM
Beschrijving
Continuous 12-Lead ECG
Alias
- UMLS CUI-1
- C0430456
- UMLS CUI-2
- C0549178
Beschrijving
Continuous 12-Lead ECG start date
Datatype
date
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0549178
- UMLS CUI [1,3]
- C0808070
Beschrijving
Continuous 12-Lead ECG start time
Datatype
time
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0549178
- UMLS CUI [1,3]
- C1301880
Beschrijving
Continuous 12-Lead ECG end time
Datatype
time
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0549178
- UMLS CUI [1,3]
- C1522314
Beschrijving
Complete the Non-Serious Adverse Events (AE) or Serious Adverse Event (SAE) page(s) if clinically significant abnormalities meet the protocol definition for an AE or SAE. Complete additional ECG Abnormalities page if clinically significant abnormalities are present.
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0549178
- UMLS CUI [1,3]
- C1274040
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Continuous 12-Lead ECG
- StudyEvent: ODM
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