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| Titel: |
Comparative Bioavailability Study of Two Ramipril Tablet Formulations in Indonesian Healthy Volunteers |
| Auteur: |
Yahdiana Harahap Lucy Sasongko Budi Prasaja Windy Lusthom Evy C. Setiawan Raria S. Meliala Lipin |
| Verschenen in: |
Journal of bioanalysis & biomedicine |
| Paginering: | Jaargang 01 (2009) nr. 01 pagina's 017-021 |
| Jaar: |
2009 |
| Inhoud: |
<p><bold>Aim</bold>To compare the bioavailability of two ramipril tablet formulations – 10 mg Prohytens® tablets as test formulation and 10 mg Triatec® tablets as reference formulation.</p><p><bold>Methods</bold> A single-dosed, open-label, randomized two-way crossover design under fasting period with two weeks wash out period was evaluated in 24 subjects. For the analysis of pharmacokinetic properties, the blood samples were drawn taken up to 72 hours after dosing. Plasma concentration of ramipril and ramiprilat were determined using liquid chromatography – tandem mass spectrometry method with TurboIonSpray mode. Pharmacokinetic parameters AUC0-t, AUC0-∞ and Cmax were tested for bioequivalence after log-transformation of data and ratios of tmax were evaluated non-parametrically.</p><p><bold>Results</bold> The point estimates and 90% confidence intervals (CI) for AUC0-t, AUC0-∞ and Cmax for ramipril were 93.21% (85.67-101.41%), 93.45% (85.88-101.69%), 94.02% (80.09-110.38%) and for ramiprilat were 92.26% (87.76- 96.99%), 94.59% (89.71-99.73%) and 91.55% (84.88- 98.74%).</p><p> <bold>Conclusion</bold> These results indicated that the two formulations of ramipril were bioequivalent and thus may be prescribedinterchangeably. |
| Uitgever: |
OMICS Publishing Group (provided by DOAJ) |
| Bronbestand: |
Elektronische Wetenschappelijke Tijdschriften |
Details van artikel 5 van 19 gevonden artikelen
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