Comparative Pharmacokinetic Assessment of Once-Daily Extended-Release and Twice-Daily Amantadine Formulations in Healthy Male Subjects Under Fasting Conditions.

ABSTRACT:

Background and objectives

Parkinson's disease (PD) affects a large population worldwide with millions of people losing motor function control. Although there is no recognized cure for PD, current medications aim to manage the symptoms and slow down the progression of the disease. Amantadine is one such treatment option that can be used in both early and late stages of PD. The current study aimed to assess the relative bioequivalence of two test prototypes (Ta and Tb) of amantadine extended-release (ER) oral formulation manufactured by Sun Pharmaceuticals Industries Limited with the reference immediate-release (IR) formulation (R) of amantadine hydrochloride manufactured by Morton Grove Pharmaceuticals Inc.

Methods

This was an open-label, balanced, randomized, three-treatment

SUBMITTER: Kumar S 

PROVIDER: S-EPMC12815974 | biostudies-literature | 2026 Jan

REPOSITORIES: biostudies-literature