Bioequivalence Study of Vortioxetine Hydrobromide Tablets in Healthy Chinese Subjects Under Fasting and Fed Conditions
| Title | Bioequivalence Study of Vortioxetine Hydrobromide Tablets in Healthy Chinese Subjects Under Fasting and Fed Conditions |
|---|---|
| Description | A bioequivalence study was conducted under fasting and fed conditions. Eligible healthy Chinese subjects received a single 10-mg dose of the test or reference vortioxetine hydrobromide tablet followed by a 28-day washout interval between periods. Serial blood samples were collected up to 72 hours after administration in each period, and plasma concentrations of vortioxetine were detected. PK parameters were calculated using the non-compartmental method.Results: Under the fasting or fed condition, the PK parameter values of the test drug were similar to those of the reference drug. Both test and reference formulations were well tolerated, and no serious adverse events were reported during the study. Conclusion: PK bioequivalence of the test and reference vortioxetine hydrobromide tablet in healthy Chinese subjects was established under fasting and fed conditions, that met predetermined regulatory criteria. Both formulations were safe and well tolerated |
| Organism | Homo sapiens |
| Data Type | Metabolome Data by Mass Spectrometry (MS) |
| Data Accessibility | Controlled-access |
| BioProject | PRJCA016915 |
| Release Date | 2023-05-12 |
| Submitter | bai wanjun (15833997197@163.com) |
| Organization | Hebei General Hospital |
| Submission Date | 2023-05-11 |
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| File ID | File Title | Number/Samples | File Type | File Size | File Suffix | Download Times | Download |
|---|---|---|---|---|---|---|---|
| OMIX004016-01 | PKCS for vortioxetine | 2 | Metabolome Data by Mass Spectrometry (MS) | 174.1 KB | zip | 0 | Controlled |