A single dose, crossover comparative exposure pharmacokinetic (PK) trial of metoclopramide nasal spray to demonstrate bioequivalence of Gimoti in healthy volunteers
Active, no longer recruiting
Phase of Trial: Phase III
Latest Information Update: 23 Oct 2017
At a glance
- Drugs Metoclopramide (Primary)
- Indications Diabetic gastroparesis
- Focus Pharmacokinetics; Registrational
- Sponsors Evoke Pharma
- 23 Oct 2017 According to an Evoke Pharma media release, based on the results from this study, company will submit a 505(b)(2) New Drug Application (NDA) with a selected Gimoti dose to the U.S. Food and Drug Administration (FDA) in the first quarter of 2018.
- 23 Oct 2017 Results presented in an Evoke Pharma Media Release.
- 23 Oct 2017 According to an Evoke Pharma media release, company planned to select a Gimoti dose based on criteria that includes a 90% confidence interval for the ratio of area under the plasma concentration curve (AUC) falling within the bioequivalence range of 80-125% of the RLD.