At a glance
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A Multicenter, Randomized, Open-label, 2-arm, 2-period Crossover Trial to Investigate the Effects of Food on the Pharmacokinetics of a Single Dose of Brexpiprazole Once-weekly (QW) Formulation in Patients With Schizophrenia
In Brief
A Phase 1 clinical trial evaluating OPC-34712FUM/ Brexpiprazole fumarate for Schizophrenia. Completed, enrolled 59 participants across 1 site.
Detailed Summary
To investigate the effect of food on the pharmacokinetics of a single dose of brexpiprazole QW formulation.
Study Details
Timeline
Interventions
In Period 1, a single oral dose of two 24 mg tablets of brexpiprazole QW formulation (48 mg as brexpiprazole) will be administered at least 10 hours of fasting. In Period 2, following at least 10 hours of fasting, the subject will consume a high-fat meal within 20 minutes, after which a single oral dose of two 24 mg tablets of brexpiprazole QW formulation (48 mg as brexpiprazole) will be administered within 10 minutes of finishing the meal.
In Period 1, following at least 10 hours of fasting, the subject will consume a high-fat meal within 20 minutes, after which a single oral dose of two 24 mg tablets of brexpiprazole QW formulation (48 mg as brexpiprazole) will be administered within 10 minutes of finishing the meal. In Period 2, a single oral dose of two 24 mg tablets of brexpiprazole QW formulation (48 mg as brexpiprazole) will be administered following at least 10 hours of fasting.