An Open-Label, One-Sequence Study to Evaluate the Steady-State Comparative Bioavailability of Intramuscular Risperidone ISM and Oral Risperidone
Phase of Trial: Phase I
Latest Information Update: 30 Jul 2019
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At a glance
- Drugs Risperidone (Primary) ; Risperidone
- Indications Schizophrenia
- Focus Pharmacokinetics; Registrational
- Acronyms BORIS
- Sponsors Rovi
- 30 Jul 2019 According to an Rovi Media release, the company will include long-term safety data on more than 100 patients exposed to at least one year of treatment with Doria in the registration dossier, as recommended in the International Conference on Harmonization (ICH) Guideline E1.
- 30 Jul 2019 According to an Rovi Media release, the company will prioritize the submission of the Doria dossier in Europe by 1Q 2020 and consequently, filing in the USA has been rescheduled for 2020.
- 05 Jul 2019 According to a Laboratorios Farmaceuticos Rovi media release, this trial is part of the Clinical Research Program for Risperidone ISM and data from this trial will be included in the registration dossier to apply for marketing authorization for Doria for the treatment of schizophrenia in the European Union and the U.S.