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

نویسندگان

  • Yahdiana Harahap
  • Lucy Sasongko
  • Budi Prasaja
  • Windy Lusthom
  • Evy C. Setiawan
  • Raria S. Meliala
چکیده

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 AUC 0-t, AUC 0-∞ and C max were tested for bioequivalence after log-transformation of data and ratios of t max were evaluated non-parametrically.

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تاریخ انتشار 2009