Bioequivalence study of two formulations of afatinib dimaleate tablets in healthy subjects under fasting conditions: A randomized, open-label, single-dose, crossover trial
The 90% CI for the geometric mean ratios (test/reference) of C<sub>max</sub>, AUC<sub>0-t</sub>, and AUC<sub>0-∞</sub> were within the range of 80.00 - 125.00%, indicating that the test formulation was equivalent to the reference formulation in healthy Chinese subjects under fasting conditions. Both products were similar in terms of safety.
Authors
- Yan Shi (ORCID: https://orcid.org/0000-0001-9777-8836)
- Yuping Ning (ORCID: https://orcid.org/0000-0002-5727-2782)
- Yanping Liu (ORCID: https://orcid.org/0009-0007-1988-3383)
- Yan Qiu (ORCID: https://orcid.org/0009-0006-0364-1390)
- Jun Ma (ORCID: https://orcid.org/0009-0008-6777-6811)
- Yanfen Dong
- Qingqing Cao (ORCID: https://orcid.org/0009-0005-6292-0528)
- Man Xu
- Juanmin Tao
- Lang Lü
Publication Details
- Journal
- International Journal of Clinical Pharmacology and Therapeutics
- Published
- 2024-08-19
- DOI
- https://doi.org/10.5414/cp204514
- Primary Topic
- Chronic Myeloid Leukemia Treatments
- Type
- article
- Field-Weighted Citation Impact
- 0.00