A Single-Dose, Replicate Crossover Design Comparative Bioavailability Study of Dronabinol Oral Solution 5 mg Versus Marinol Capsules 5 mg Under Fasted Conditions
Phase of Trial: Phase I
Latest Information Update: 07 Jun 2016
At a glance
- Drugs Dronabinol (Primary)
- Indications Anorexia; Nausea and vomiting
- Focus Pharmacokinetics
- Sponsors INSYS Therapeutics, Inc
- 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.