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STUDY OF POTENTIAL PHARMACOKINETIC DRUG INTERACTIONS AFFECTING ORAL BIOAVAILABILITY OF LERCANIDIPINE. Aarti Midha, Aman Singla, Yash Paul, and Bhupinder Singh

STUDY OF POTENTIAL PHARMACOKINETIC DRUG INTERACTIONS AFFECTING ORAL BIOAVAILABILITY OF LERCANIDIPINE.

Aarti Midha, Aman Singla, Yash Paul, and Bhupinder Singh

International Journal of Natural Product Science 2012: Spl Issue 1:251.

Abstract(RBIP-251)

Objective: The objective of the current investigation was to study the potential influence of fluconazole, and pomegranate juice (Real Power) on the oralbioavailability of lercanidipine in healthy human volunteers.

Experimental Methods: After obtaining the requisite approval from the Institutional Ethics Committee, six healthy human male adult volunteers were administered with lercanidipine alone and in combination with the above-mentioned drug and juice interactants. Plasma samples, collected as per the pre-determined schedule, were assayed for lercanidipine concentration employing reversed phase-HPLC method, previously developed and validated in our laboratories.Compartmental pharmacokinetic analysis on the plasma concentration data of lercanidipine was carried out using WinNonlin 5.2 software with 2-CBM kinetics as the best-fit model. Non-compartmental stochastic pharmacokinetic analysis of the data was also carried out using Kinetica 5.0 software. Statistical significance of the data was determined through three-way cross-over analysis using an in-house developed program, CROSS.

Results: The results suggested that concurrent administration of fluconazole, and pomegranate juice (Real Power) significantly increased the extent of drug bioavailability. Administration of fluconazole significantly increased the extent of bioavailability of lercanidipine, as deduced from over 54% increase in mean AUC values, and over 51% increase in the values of Cmax with respect to the control. A 47% increase in the values of Cmax and 42% increase in mean AUC values with respect to control indicated reduction in the extent of bioavailability of lercanidipine following its co- administrations with pomegranate juice.

Conclusions: In the light of above outcomes, it can be concluded that lercanidipine should be administered at least 2-3h before or 4-6h after the administration of potentially interacting preparations like fluconazole, pomegranate juice, etc. to avoid any therapeutic failure(s).
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