Trial Profile

A clinical study of HTX-019 via 2-min injection or 30-min infusion in healthy subjects

Status: Completed

Phase of Trial: Phase I

Latest Information Update: 05 Mar 2019

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At a glance

Drugs Aprepitant (Primary) ; Aprepitant
Indications Chemotherapy-induced nausea and vomiting
Focus Adverse reactions; Pharmacokinetics; Registrational
Sponsors Heron Therapeutics

Most Recent Events

05 Mar 2019 New trial record
26 Feb 2019 According to a media release, based on the data of this study, the US FDA has approved the supplemental New Drug Application (sNDA) for CINVANTI (aprepitant) injectable emulsion, for intravenous (IV) use. The sNDA requested FDA approval to expand the administration of CINVANTI beyond the already approved administration method (a 30-minute IV infusion) to include a 2-minute IV injection.

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