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The bioequivalence of two slow-release diltiazem formulations [formulation A (Cardizem®, Marion Merrell Dow) and formulation B (Dilter®, Natco Pharma)] was investigated in 12 healthy volunteers in a double-blind crossover study. Atrioventricular conduction time (PQ interval) was taken as a pharmacodynamic response to assess bioequivalence. An ECG recording was carried out before and at various time intervals after drug administration and PQ interval was measured. The mean PQ interval before administration of either formulation was similar. There was significant prolongation of the PQ interval from the second hour onwards with the two formulations. With Dilter®, mean maximum PQ interval (Emax) was 0.2 ± 0.03 msec, peak time (tmax) was 2.67 ± 0.98 hours and area under the effect-time curve (AUC) was 4.18 ± 0.47 msec·h. With Cardizem®, the mean values were 0.2 ± 0.04 msec, 2.83 ± 1.03 hours and 4.23 ± 0.4 msec·h for Emax, tmax and AUC, respectively. Both formulations produced similar decreases in systolic and diastolic blood pressures and heart rate. All pharmacodynamic variables used to assess the bioequivalence of the two formulations were found to be comparable. The estimate of the rate and extent of the effect on PQ interval and the AUC suggested that both formulations were bioequivalent. |
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