ID

40799

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 Vital Signs Form has to be filled in at following visits: Screening, Treatment Period 1 Predose, Treatment Period 1 Prior to Discharge, Treatment Period 2 Predose, Treatment Period 2 Prior to Discharge, and whenever further assesments are done during the study (Unscheduled).

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

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GlaxoSmithKline

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May 15, 2020

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