Teva Medical Information Consulting (Shanghai) Co., Ltd.

To evaluate the safety, tolerability, and pharmacokinetics of a single dose of subcutaneous olanzapine extended-release suspension (TV-44749) in Chinese patients with schizophrenia.

Schizophrenia is a debilitating, severe psychotic disorder characterized by both positive and negative symptoms with a global lifetime risk of approximately 1%. For most patients, the disease is associated with a chronic course requiring long-term antipsychotic treatment. Nonadherence and noncompliance with long-term oral medication regimens are the most important treatment issues in the treatment of schizophrenia and related disorders, resulting in many of these patients experiencing frequent relapses or exacerbations and failing to fully benefit from antipsychotic treatment. Extended-release injectable antipsychotics may improve adherence in patients with schizophrenia. Currently, oral, long-acting intramuscular (IM), and rapid-acting IM formulations of olanzapine are approved for the treatment of adults with schizophrenia. A new formulation of olanzapine extended-release suspension (TV-44749) for subcutaneous injection (sc) is intended for the treatment of schizophrenia.

To evaluate the pharmacokinetic profiles of TEV-50717 (parent drug) and its active deuterated metabolites α-dihydrotetrabenazine (α-HTBZ) and β-dihydrotetrabenazine (β-HTBZ) (total and individual components) after a single oral dose of 12 mg TEV-50717 tablets in healthy Chinese male and female subjects after a meal.