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This study is to preform a comparative pharmacokinetic study of Dronabinol XL AdVersa® versus the listed drug.
This study is to preform a comparative pharmacokinetic study of Dronabinol XL AdVersa® versus the listed drug.
Status:Planning
Phase of Trial:
Phase I
Latest Information Update:27 Sep 2018
Price :
$35
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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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