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Bioequivalence Study of Sublingual BHV-0223 Zydis Orally Dissolving Tablet in Healthy Volunteers

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Trial Profile

Bioequivalence Study of Sublingual BHV-0223 Zydis Orally Dissolving Tablet in Healthy Volunteers

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 30 Oct 2019

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At a glance

  • Drugs Riluzole (Primary) ; Riluzole
  • Indications Amyotrophic lateral sclerosis
  • Focus Pharmacokinetics; Registrational
  • Sponsors Biohaven Pharmaceutical Holding Company

    • Most Recent Events

    • 14 Oct 2019 Results assesing bioequivalence and food effects of sublingual and oral Riluzole formulations were published in the Clinical Pharmacology in Drug Development
    • 19 Jul 2019 According to a Biohaven Pharmaceutical Holding Company, the company fas been subsequently informed by the manufacturer that they had an exemption from the FDA to supply riluzole to the U.S. market during that time period. The company has been in contact with the FDA's CMC group and Apotex to resolve the matter and Biohaven has already submitted additional information to the FDA regarding this issue.
    • 19 Jul 2019 According to a Biohaven Pharmaceutical Holding Company, In the CRL, the FDA stated that it provided recommendations to Apotex regarding the information that would be needed to qualify previous API batches manufactured at Apotex during the time period in question. Apotex did not provide Biohaven with notice of the FDA communication, either during the course of its bioequivalence trial or during the submission of its 505(b)2 application for Nurtec (riluzole).
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