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This study is to preform a comparative pharmacokinetic study of Dronabinol XL AdVersa® versus the listed drug.

Trial Profile

This study is to preform a comparative pharmacokinetic study of Dronabinol XL AdVersa® versus the listed drug.

Planning
Phase of Trial: Phase I

Latest Information Update: 27 Sep 2018

At a glance

  • Drugs Dronabinol (Primary)
  • Indications Chemotherapy-induced nausea and vomiting
  • Focus Pharmacokinetics; Registrational
  • Sponsors Tetra Bio Pharma
  • Most Recent Events

    • 27 Sep 2018 According to a Tetra Bio Pharma media release, the company anticipates submitting a New Drug Application to commercialize PPP002 in Q1 2019.
    • 13 Jun 2018 According to a Tetra Bio Pharma media release, if this trial proves the equivalence of test product to the reference product, the company anticipates filing for approval under 505(B)2 route in the USA in Q4 of 2018.
    • 13 Jun 2018 According to a Tetra Bio Pharma media release, the company expects to launch this study in the third quarter of 2018.
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