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KMID : 0369820070370060397
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Jorunal of Korean Pharmaceutical Sciences
2007 Volume.37 No. 6 p.397 ~ p.402
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Bioequivalence of XR capsule to OR tablet (Venlafaxine 75 mg)
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Aryal Dipendra Kumar
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 venlafaxine formulations, a standard 2-way randomized cross-over study was conducted in twenty-four healthy male Korean volunteers. A single oral dose of 75 mg of test formulation Venfaxine (tablet) or reference formulation Efexor (capsule) was administered with one-week washout period. Plasma concentrations of venlafaxine were assayed for over a period of 72 hours with a well validated method using liquid chromatography coupled to tandem mass spectrometry (LC-MS-MS). The . of maximum concentration and elimination half-life were ng/mL, h, and ng/mL, h for test and reference formulations, respectively. Time to reach maximum concentration expressed in median value (range), for the test and the reference, were 10 h (6-14) and 8h (4-12), respectively. Similarly, area under the plasma concentration-time curve, from time zero to last sampling time and from time zero to time infinity , for test and reference formulations were , and , , respectively. The parametric 90% confidence intervals on the mean of the differences between the two formulations (test-reference) of the log transformed values of , and were 0.9630 to 1.1383 and 0.8650 to 1.0446, respectively. The overall results indicate that the two formulations are bioequivalent and can be prescribe interchangeably.
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KEYWORD
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Venlafaxine, Pharmacokinetics, Bioequivalence, LC-MS-MS
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