A bioequivalence study in healthy subjects for PF-708

Trial Profile

A bioequivalence study in healthy subjects for PF-708

Completed
Phase of Trial: Phase I

Latest Information Update: 09 Aug 2017

At a glance

  • Drugs Teriparatide (Primary)
  • Indications Osteoporosis
  • Focus Pharmacokinetics; Registrational
  • Most Recent Events

    • 09 Aug 2017 According to a Pfenex media release, the company expects to submit the new drug application (NDA) in the third quarter of 2018 to the FDA.
    • 15 Mar 2017 Status changed from active, no longer recruiting to completed, according to a Pfenex media release.
    • 15 Mar 2017 According to a Pfenex media release, this study, along with the phase III study (profile 271298), is anticipated to satisfy the filing requirements for PF708 through the 505(b)(2) regulatory pathway.
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