Comparative Pharmacokinetic Assessment of Once-Daily Extended-Release and Twice-Daily Amantadine Formulations in Healthy Male Subjects Under Fasting Conditions
These findings confirm the bioequivalence of the two test prototypes of amantadine ER formulation manufactured by Sun Pharmaceutical Industries Limited with the IR BID formulation of amantadine manufactured by Morton Grove Pharmaceuticals Inc. The pharmacokinetic equivalence supports the use of OD amantadine ER as an alternative to the BID IR formulation, with the potential to improve patient adherence due to reduced dosing frequency.
Authors
- Simrata Bedi
- Abhishek Tyagi (ORCID: https://orcid.org/0000-0002-0155-2099)
- Sanjay Jagannath Gurule
- Abhishek Srivastava (ORCID: https://orcid.org/0000-0002-9480-0847)
- Arshad Hussain Khuroo (ORCID: https://orcid.org/0000-0001-5308-4648)
- Shailbala Singh (ORCID: https://orcid.org/0000-0002-0681-3948)
- Chintan Khandhedia (ORCID: https://orcid.org/0009-0004-5632-7181)
- P. H. Devkare
- Shruti Dharmadhikari (ORCID: https://orcid.org/0000-0002-2249-2662)
- Sudershan Kumar
Institutions
- Sun Pharma (India) (IN)
- Sun Pharma Advanced Research (India) (IN)
Publication Details
- Journal
- Clinical Drug Investigation
- Published
- 2025-11-12
- DOI
- https://doi.org/10.1007/s40261-025-01485-0
- Primary Topic
- Pharmacogenetics and Drug Metabolism
- Type
- article
- Field-Weighted Citation Impact
- 0.00
Funders
- Sun Pharma