Journal de bioanalyse et de biomédecine

Comparative Bioavailability Study of Two Ramipril Tablet Formulations in Indonesian Healthy Volunteers

Abstract

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.