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 Randomized Open-Label Three-Way Crossover Study to Compare the Pharmacokinetics, Safety, and Tolerability of Two Lots of M207 3.8 mg (Administered as Two 1.9 mg Patches on the Upper Arm for 30 Minutes) and Intranasal Zolmitriptan 5.0 mg x 2 Doses in Healthy Volunteers

Next Previous
X
Search
Trial Profile

A Randomized Open-Label Three-Way Crossover Study to Compare the Pharmacokinetics, Safety, and Tolerability of Two Lots of M207 3.8 mg (Administered as Two 1.9 mg Patches on the Upper Arm for 30 Minutes) and Intranasal Zolmitriptan 5.0 mg x 2 Doses in Healthy Volunteers

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 23 Mar 2022

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 Zolmitriptan (Primary) ; Zolmitriptan (Primary)
  • Indications Cluster headache; Migraine
  • Focus Adverse reactions; Pharmacokinetics; Registrational
  • Sponsors Zosano Pharma

    • Most Recent Events

    • 17 Mar 2022 According to a Zosano Pharma media release, company is communicating with FDA to evaluate next steps following their letter indicating the resubmitted M 207 New Drug Application (NDA) did not constitute a complete response to deficiencies identified by the FDA's Complete Response Letter (CRL). The company is also in discussions with the FDA to determine if there is a viable option to pursue approval of M 207 using the currently available clinical data.
    • 04 Oct 2021 According to a Zosano Pharma media release, the company plan to provide update on resubmission plans after receiving written feedback from the FDA, which is expected to occur by mid-December.
    • 04 Oct 2021 Results published in the Zosano Pharma Media Release.

You need to be a logged in or subscribed to view this content Request demo

If your organization or you do not have a subscription, try one of the following:
  • Contacting your organization’s admin about adding this content to your AdisInsight subscription
  • Buying a PDF version of any individual profile
  • Request a free trial
If your organization has a subscription, there are several access options, even while working remotely:
  • Working within your organization’s network
  • with username/password or try to via your institution
  • Persisted access using your organization’s identifier stored in your user browser for 90 days
Back to top