Assessment of Pharmacokinetics and Safety with Bioequivalence of the Nitroglycerin Sublingual Tablets of Two Formulations in Chinese Healthy Subjects: A Bioequivalence Study
The study confirmed bioequivalence between the test and reference formulations, demonstrating equivalent absorption rates (C<sub>max</sub>) and extents (AUC). Rapid therapeutic plasma levels were achieved via sublingual administration, aligning with nitroglycerin's clinical need for prompt angina relief. These findings, combined with favorable safety data, support the test formulation as a therapeutically equivalent alternative.
Authors
- Chunqi Huang (ORCID: https://orcid.org/0000-0002-8667-0034)
- Yanzhu Liu
- Yingying Xu (ORCID: https://orcid.org/0000-0002-5848-2642)
- Xiufeng Xu (ORCID: https://orcid.org/0000-0003-2941-4859)
- Ying Wang (ORCID: https://orcid.org/0000-0003-2121-7025)
- Yu Wang (ORCID: https://orcid.org/0000-0001-8826-7911)
- Lei Yang (ORCID: https://orcid.org/0000-0002-7447-5645)
- Qi Fu (ORCID: https://orcid.org/0000-0002-1626-0419)
- Bin Zhu (ORCID: https://orcid.org/0000-0002-9187-8024)
- Fang Tian
- Yuan Yuan (ORCID: https://orcid.org/0000-0001-7440-8939)
Institutions
- Zhejiang Chinese Medical University (CN)
- Hangzhou Normal University (CN)
- Sino Biopharmaceutical (China) (CN)
- The Third Affiliated Hospital of Zhejiang Chinese Medical University (CN)
- Affiliated Hangzhou First People's Hospital, Westlake University, School of Medicine (CN)
- Hangzhou Red Cross Hospital (CN)
- Second Affiliated Hospital of Zhejiang University (CN)
Publication Details
- Journal
- Drugs in R&D
- Published
- 2025-08-08
- DOI
- https://doi.org/10.1007/s40268-025-00519-4
- Primary Topic
- Heart Failure Treatment and Management
- Type
- article
- Field-Weighted Citation Impact
- 0.00