Yahdiana Harahap, Lucy Sasongko, Budi Prasaja, Windy Lusthom, Evy C. Setiawan, Raria S. Meliala and Lipin
Aim
To compare the bioavailability of two ramipril tabl et for- mulations – 10 mg Prohytens ® tablets as test formulation and 10 mg Triatec ® tablets as reference formulation.
Methods
A single-dosed, open-label, randomized two-way cros s- over design under fasting period with two weeks was h out period was evaluated in 24 subjects. For the an alysis of pharmacokinetic properties, the blood samples we re drawn taken up to 72 hours after dosing. Plasma con cen- tration of ramipril and ramiprilat were determined using liquid chromatography – tandem mass spectrometry method with TurboIonSpray mode. Pharmacokinetic pa- r a meter s AUC 0 -t, AUC 0- ∞ a nd C max wer e tes ted for bioequivalence after log-transformation of data and ratios of t max were evaluated non-parametrically.
Results
The point estimates and 90% confidence intervals (C I) for AUC 0-t, AUC 0- ∞ and C max 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%).
Conclusion
These results indicated that the two formulations o f ramipril were bioequivalent and thus may be prescri bed interchangeably.
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