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Details van artikel 14 van 105 gevonden artikelen
| Titel: |
Comparative bioavailability between two prescriptions of gabapentin 300 mg in |
| Auteur: |
Parra Sergio Cuesta Fanny Restrepo Margarita Archbold Rosendo Montoya Blanca Holguín Gloria Ríos Juan Carlos |
| Verschenen in: |
Colombia médica |
| Paginering: | Jaargang 35 (2004) nr. 1 pagina's 5-11 |
| Jaar: |
2004 |
| Inhoud: |
Introduction: To compare the bioavailability between two pharmaceutical equivalent products. To allow the demonstration of the bioequivalence or not, of two formulations submitted to study under similar experimental conditions. Objective: The pharmaceutical products of Gabapentin capsules of 300 mg: Gabantex®/Gabapentina MK, test product, which belongs to Tecnoquímicas S.A., and Neurontin®, as the reference product, which belongs to Parke- Davis, were submitted to a study in vivo to determine their biological equivalence. Methods: This study was carried out in 14 healthy volunteers under a randomized crossover design, with single doses. They received 600 mg of each product and blood samples were collected for a period of 36 hours. The gabapentin in plasma was determined by a validated liquid chromatography method with fluorescence detector. Bioavailability was compared for pharmacokinetic parameters: total area under the plasma concentration-time curve (AUC0¥), peak plasma concentration (Cmax), maximum time to reach the peak plasma concentration (Tmax) and early exposure (AUC0Tmax). Results: 90% confidence intervals by the test product were: 87.5%-114.5% for AUC0¥; 85.0%-109.7% for Cmax; and 97.9%-118.8% for AUC0Tmax. These parameters were contained within the confidence interval from 80%-125% of the reference product. The confidence interval for Tmax was 68.4%-94.5%, this was not contained within the confidence interval from 80%-120% of the reference product. Discussion: In this study the pharmacokinetic parameter of greater difference was the Tmax to reach the Cmax; difference that is explained by factors such as the origin of drug substance, excipients, and the pharmaceutical technology used. Conclusions: The two formulations were bioequivalent with respect to AUC0¥, Cmax and AUC0Tmax, and not bio-equivalent in relation to Tmax. These findings guarantee that when using the test product, a therapeutic answer similar to the reference product will be obtained. |
| Uitgever: |
Corporación Editora Médica del Valle (provided by DOAJ) |
| Bronbestand: |
Elektronische Wetenschappelijke Tijdschriften |
Details van artikel 14 van 105 gevonden artikelen
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