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A single dose, crossover comparative exposure pharmacokinetic (PK) trial of metoclopramide nasal spray to demonstrate bioequivalence of Gimoti in healthy volunteers

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Trial Profile

A single dose, crossover comparative exposure pharmacokinetic (PK) trial of metoclopramide nasal spray to demonstrate bioequivalence of Gimoti in healthy volunteers

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 27 Jan 2020

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At a glance

  • Drugs Metoclopramide (Primary) ; Metoclopramide
  • Indications Diabetic gastroparesis
  • Focus Pharmacokinetics; Registrational
  • Sponsors Evoke Pharma

    • Most Recent Events

    • 23 Jan 2020 According to an Evoke Pharma media release, the U.S. Food and Drug Administration (FDA) has set a target goal date under the Prescription Drug User Fee Act (PDUFA) of June 19, 2020.
    • 20 Dec 2019 According to an Evoke Pharma media release, the company has submitted resubmitted its 505(b)(2) New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Gimoti for the relief of symptoms in adult women with acute and recurrent diabetic gastroparesis.
    • 20 Dec 2019 According to an Evoke Pharma media release, the resubmission includes 3-month stability data from commercial scale registration batches that met all product specifications and support the proposed acceptance criteria for performance characteristics and device quality control and includes data from an analysis of pump performance characteristics for the product used in the comparative bioavailability study and the product from commercial scale registration batches.

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