A Phase 1, Randomized, Open-Label Study to Assess the Bioequivalence of Trofinetide as a Ready-to-Use Oral Solution and Constituted Powder for Oral Solution in Healthy Adults
The bioequivalence demonstrated in this study supports the clinical interchangeability of TPOS and TOS and shows that TPOS can be constituted using adjustable volumes of water without affecting bioavailability. There were no unexpected adverse events reported with trofinetide when administered as TPOS and TOS.
Authors
- Sanjeev Pathak (ORCID: https://orcid.org/0000-0001-5842-690X)
- Amy Yamamoto
- Yvonne Holmes Adegbenle
- Mona Darwish
- James M. Youakim (ORCID: https://orcid.org/0000-0001-5551-8956)
- Ravi Tejwani
- Yonghua Chen
- Rene Nunez-Disla
Institutions
- Acadia Pharmaceuticals (United States) (US)
Publication Details
- Journal
- Advances in Therapy
- Published
- 2026-02-12
- DOI
- https://doi.org/10.1007/s12325-025-03484-1
- Primary Topic
- Pharmaceutical studies and practices
- Type
- article
- Field-Weighted Citation Impact
- 0.00