A single-dose, randomized, open-label, three-way crossover comparative bioavailability study of RIZAPORT® 10 mg, Maxalt®-MLT 10 mg orally disintegrating tablets and Maxalt®-Lingua 10 mg oro-dispersible tablets
Phase of Trial: Phase I
Latest Information Update: 20 Nov 2018
At a glance
- Drugs Rizatriptan (Primary) ; Rizatriptan
- Indications Migraine
- Focus Pharmacokinetics; Registrational
- Sponsors IntelGenx Corp.
- 20 Nov 2018 According to an IntelGenx Corp media release, US FDA has accepted for review the resubmission of the 505(b)(2) New Drug Application (NDA) RIZAPORT oral soluble film 10 mg for the treatment of acute migraines. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date for completion of the review of the RIZAPORT NDA of April 1, 2019.
- 31 Oct 2018 According to an IntelGenx Corp media release, the Spanish Agency of Medicines and Medical Devices (AEMPS) has granted national marketing authorization for RIZAPORT (10mg) in Spain.
- 01 Oct 2018 New trial record