A Bioequivalence Study of a Test Product Compared to a Reference Product in Adult Patients with Schizophrenia Under Fasting Conditions

The primary objective of this study is to evaluate the bioequivalence of a test product compared to a reference product used in the management of schizophrenia. Establishing bioequivalence is clinically significant to ensure that the generic formulation provides a comparable level of therapeutic effect and bioavailability to the innovator drug. The study will be conducted under fasting conditions.

The sponsor did not provide information regarding the total number of participants. The study population consists of healthy volunteers, including both males and females, who are categorized as a vulnerable population. The participants fall within age range 3. The clinical investigation is conducted under fasting conditions for a bioequivalence study.

This Phase II bioequivalence study is designed to compare a test product against a reference product for the treatment of schizophrenia. The research methodology utilizes a fasting protocol to evaluate the pharmacological equivalence of the formulations. The trial sequence includes an initial screening visit to assess eligibility, followed by specific study visits to monitor physiological parameters and drug absorption. The clinical investigation concludes with an end-of-study visit. The estimated duration of the study period is from October 27, 2025, to December 19, 2025. Early termination of participation may occur based on predefined clinical criteria or protocol non-compliance.

The efficacy of the investigational product is evaluated through a bioequivalence assessment conducted under fasting conditions.