ID

40803

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. This form has to be filled in during Treatment Period 2. Planned Timepoint: Day 1. Record any changes to the subject’s concomitant medications or any new medications taken since the last visit in the appropriate Concomitant Medications section. Review adverse events at 4 and 12 hours post-dose, in addition to any spontaneously reported AEs throughout the day. Record details of any new adverse events observed or reported by the subject or any changes to ongoing adverse events in the appropriate Non-Serious Adverse Events/Serious Adverse Event section.

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1. 5/15/20 5/15/20 -

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GlaxoSmithKline

Uploaded on

May 15, 2020

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