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A Single-Dose, Replicate Crossover Design Comparative Bioavailability Study of Dronabinol Oral Solution 5 mg Versus Marinol Capsules 5 mg Under Fasted Conditions

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Trial Profile

A Single-Dose, Replicate Crossover Design Comparative Bioavailability Study of Dronabinol Oral Solution 5 mg Versus Marinol Capsules 5 mg Under Fasted Conditions

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 19 Jul 2016

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At a glance

  • Drugs Dronabinol (Primary)
  • Indications Anorexia; Nausea and vomiting
  • Focus Pharmacokinetics
  • Sponsors INSYS Therapeutics, Inc

Most Recent Events

  • 07 Jun 2016 Results of comparative bioavailability study of dronabinol oral solution versus dronabinol capsules (n=52) presented at the 52nd Annual Meeting of the American Society of Clinical Oncology
  • 07 Jun 2016 Results assessing the effect of food on pharmacokinetics of dronabinol oral solution versus capsules (n=54) presented at the 52nd Annual Meeting of the American Society of Clinical Oncology.
  • 02 Jun 2015 According to an Insys Therapeutics media release, a New Drug Application has been re-submitted to the US FDA. Earlier a 'Refusal to File' letter was received in October 2014 for previously submitted NDA due to inadequate or incomplete pediatric study plan.

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