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Bioequivalence and Pharmacokinetic Evaluation of Two Oral Formulations of Regorafenib: An Open-Label, Randomised, Single-Dose, Two-Period, Two-Way Crossover Clinical Trial in Healthy Chinese Volunteers Under Fasting and Fed Conditions
| Content Provider | Scilit |
|---|---|
| Author | Zhang, Qian Wang, Zhiqiang Wu, Jingying Zhou, Zhen Zhou, Renpeng Hu, Wei |
| Copyright Year | 2021 |
| Description | Background: Regorafenib is an oral multi-kinase inhibitor approved for the treatment of solid tumours, but the pharmacokinetic profile of regorafenib in the Chinese population is unclear. Objective: The aim of this study was to examine the pharmacokinetics, bioequivalence, and safety of two formulations of regorafenib 40 mg in healthy Chinese volunteers under fed and fasting conditions. Methods: A single-centre, randomised, open-label, two-period, two-way crossover phase 1 trial was conducted by randomising a single oral dose of test (T) or reference (R, $Stivarga^{®}$) regorafenib (40 mg) to healthy Chinese volunteers under both fasting and fed conditions (high-fat and high-calorie diet). Pharmacokinetic parameters were calculated using non-compartmental methods. Adverse events were recorded to assess drug safety. Results: Sixty-six participants were enrolled for both fasting and fed treatments. The 90% CIs geometric least-square means of $ratio_{T/R}$ for regorafenib were completely contained within the equivalence margin of 80– 125% under both fasting and fed conditions. Both formulations displayed similar and generally good safety profiles. Conclusion: Single oral dose of the T (40 mg) and R (40 mg) regorafenib was bioequivalent under fasting and fed conditions and had similar favourable safety profiles among healthy Chinese volunteers. |
| Related Links | https://www.dovepress.com/getfile.php?fileID=72153 |
| Ending Page | 3288 |
| Page Count | 12 |
| Starting Page | 3277 |
| e-ISSN | 11778881 |
| DOI | 10.2147/dddt.s323169 |
| Journal | Drug design, development and therapy |
| Volume Number | 15 |
| Language | English |
| Publisher | Informa UK Limited |
| Publisher Date | 2021-07-01 |
| Access Restriction | Open |
| Subject Keyword | Journal: Drug Design, Development and Therapy Oncology Regorafenib Phase 1 Pharmacokinetic Bioequivalence Chinese Healthy Volunteers |
| Content Type | Text |
| Resource Type | Article |
