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Drug drug interaction clinical study to evaluate the drug interaction effect of a strong CYP3A4 inhibitor or inducer when co-administered with brilaroxazine in healthy volunteers

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Trial Profile

Drug drug interaction clinical study to evaluate the drug interaction effect of a strong CYP3A4 inhibitor or inducer when co-administered with brilaroxazine in healthy volunteers

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 22 Aug 2024

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At a glance

  • Drugs Brilaroxazine (Primary) ; Itraconazole; Phenytoin
  • Indications Idiopathic pulmonary fibrosis; Pulmonary arterial hypertension; Schizoaffective disorder; Schizophrenia
  • Focus Pharmacokinetics

Most Recent Events

  • 14 Aug 2024 According to a Reviva Pharmaceuticals media release, positive data from this drug-drug interaction (DDI) study investigating the potential effect of CYP3A4 enzyme on brilaroxazine in healthy subjects, supports no clinically significant interaction when combined with a CYP3A4 inhibitor.
  • 04 Jan 2023 According to a Reviva Pharmaceuticals media release, data from this trial along with the results from our pivotal Phase 3 trials will be submitted as a part of New Drug Application (NDA) for brilaroxazine in schizophrenia.
  • 21 Dec 2022 New trial record

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