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KMID : 0369820080380010073
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Jorunal of Korean Pharmaceutical Sciences
2008 Volume.38 No. 1 p.73 ~ p.78
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Bioequivalence of Ramiprin tablet to Tritace Protect tablet (Ramipril 10 mg)
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Oh Soo-Yeon
Cho Jong-Tae
Kim Hyung-Gun
Kim Yoon-Gyoon
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Abstract
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To evaluate the bioequivalence of two ramipril formulations, a standard 2-way randomized cross-over study was conducted in twenty-six healthy male Korean volunteers. A single oral dose of 10 mg of test formulation (tablet) or reference formulation Tritace (tablet) was administered with one-week washout period. Plasma concentrations of ramipril were assayed over a period of 12 hr with a well validated method using liquid chromatography coupled to tandem mass spectrometry (LC-MS/MS). The values of area under the plasma concentration-time curve, from time zero to last sampling time and from time zero to time infinity were for test, and for reference formulation, respectively. Similarly, maximum concentration and elimination half-life were and for test, and and for reference formulations, respectively. Time to reach maximum concentration for the test and the reference, were , respectively. The parametric 90% confidence intervals on the mean of the differences between the two formulations (test-reference) of the log-transformed values of were 1.03 to 1.19 and 0.98 to 1.17, respectively. The overall results indicate that the two formulations are bioequivalent and can be prescribed interchangeably.
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KEYWORD
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Ramipril, Pharmacokinetics, Bioequivalence, LC-MS/MS
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