Article ; Online: The Bioequivalence Study of Two Dexketoprofen 25 mg Film-Coated Tablet Formulations in Healthy Males Under Fasting Conditions.
Turkish journal of pharmaceutical sciences
2023 Volume 20, Issue 2, Page(s) 115–120
Abstract: Objectives: Dexketoprofen is a non-steroidal analgesic/anti-inflammatory drug and its trometamol salt is extensively preferred in mild or moderate pain due to its rapid onset of relief. A new formulation of 36.9 mg of dexketoprofen trometamol ( ... ...
| Abstract | Objectives: Dexketoprofen is a non-steroidal analgesic/anti-inflammatory drug and its trometamol salt is extensively preferred in mild or moderate pain due to its rapid onset of relief. A new formulation of 36.9 mg of dexketoprofen trometamol (equivalent to 25 mg dexketoprofen) tablet has been developed and its bioequivalence to the reference product was proven. Materials and methods: An open-label, single-dose, randomized, two-period, and cross-over bioequivalence study was conducted with healthy males under fasting conditions for two different tablet formulations of 25 mg dexketoprofen. To prove the bioequivalence of the test product with the reference product, a comparison study has been performed in compliance with regulations in force under Good Clinical Practice principles. A single-center clinical study was run and blood samples of the participants were withdrawn at specified time points, before and after dosing, to measure the plasma concentrations of dexketoprofen trometamol. A validated analytical method has been developed using an liquid chromatography with tandem mass spectrometry. Instrument to assess the plasma concentrations of the test and reference products. Results: Forty-seven volunteers completed clinical phase of the study. For the test and reference products, the mean ± standard deviations (SD) of C Conclusion: After statistical evaluation of the analytical results, the test and reference products were considered bioequivalent. Both products were well tolerated and considered as safe. |
|---|---|
| Language | English |
| Publishing date | 2023-05-09 |
| Publishing country | Turkey |
| Document type | Journal Article |
| ZDB-ID | 2238484-4 |
| ISSN | 2148-6247 ; 2148-6247 |
| ISSN (online) | 2148-6247 |
| ISSN | 2148-6247 |
| DOI | 10.4274/tjps.galenos.2022.95994 |
| Database | MEDical Literature Analysis and Retrieval System OnLINE |
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