Either you have JavaScript disabled or your browser does not support Javascript . To work properly, this page requires JavaScript to be enabled.
How to enable JavaScript in your browser?

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

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

Price : $35 *
  • Adis is an information provider.
  • Final gross price and currency may vary according to local VAT and billing address.
  • Your purchase entitles you to full access to the information contained in our trial profile at the time of purchase.
  • A link to download a PDF version of the trial profile will be included in your email receipt.

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.
Subscriber content

You need to be a logged in subscriber to view this content.

If your organization has a subscription then there are several options available to help you access AdisInsight, even while working remotely.

  • IP authentication when working within your organization’s network.
  • with username/password or try via your institution
  • Persisted access using your organization’s identifier stored in your user browser for 90 days.
  • Contact us at AsktheExpert.AdisInsight@springer.com for assistance.

If your organization does not have a subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Buy a PDF version of the profile.
  • Request a free trial
Back to top