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First received: March 09, 2023

Clinical Trial: Study to Evaluate the Pharmacokinetics (PK) and Safety/Tolerability of Long-Acting Oral LYN-005

Study Status: Completed

Recruit Status: RECRUITING

Condition: Schizophrenia

Study Type: INTERVENTIONAL


Official Title: A Multi Dose, Open-Label, Parallel-Group Study to Evaluate the PK and Safety/Tolerability of Long-Acting Oral Risperidone (LYN-005) in Participants With Schizophrenia or Schizoaffective Disorder

Brief Summary: Lyndra Therapeutics, Inc. is developing LYN-005, a long-acting oral (LAO) capsule (LYNX™ dosage form) of risperidone.This pivotal study (LYN-005-C-301) will evaluate the PK as well as safety and tolerability of multiple administrations of the LYN-005 formulation at two dose levels.

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