Novast Pharmaceutical Co., Ltd. has launched a bioequivalence study for its Venlafaxine Hydrochloride Extended Release Tablets. The clinical trial registration number is CTR20253354, with initial disclosure dated August 19, 2025.

The tablet formulation is administered orally at a single dose of one 75 mg tablet per cycle. The trial aims to evaluate the pharmacokinetic profile of Nantong Novast’s Venlafaxine Hydrochloride ER Tablets (75 mg) under fed conditions, using the Trigen Laboratories, LLC distributed version as the reference. The study will assess bioequivalence between the two formulations and monitor their safety in healthy participants.

Venlafaxine Hydrochloride ER Tablets are indicated for major depressive disorder (including depression with anxiety) and generalized anxiety disorder (GAD). Depression is characterized by persistent low mood and loss of interest, while GAD involves excessive, uncontrollable worry. Diagnosis is based on symptomatic presentation and psychiatric evaluation.

Primary endpoints include AUC and Cmax within 72 hours post dose. Secondary endpoints comprise Tmax, λz, t1/2, Vd/F, and CL/F over the same period. Safety outcomes include adverse events (AEs), serious AEs (SAEs), and clinically significant changes in vital signs, physical examinations, lab tests, and ECGs.

The trial is currently ongoing but not yet recruiting.