KeywordsĮnterohepatic re-circulation, clonidine hydrochloride, area under curve, analysis of variance,Ĭlonidine is an antihypertensive agent, which actsĬentrally by stimulating alpha 2-adrenergic receptors and
Based on the results obtained, two different brands of clonidine 25 μg tablets have comparable rate and extent of absorption after oral administration but failed to show bioequivalence as per regulatory requirement of Food and Drugs Administration-united states. No meaningful values of K el and therefore AUC under 0-infinity could be calculated for significant number of subjects due to enterohepatic re-circulation. Analysis of variance did not show significant difference to these parameters. The 90% confidence intervals of test/reference ratios for C max and area under the plasma-concentration- time-curve AUC under 0-t were found to be between 0.80 and 1.25 for log-transformed data. The plasma concentrations of clonidine were quantified by validated LCMS/MS method and pharmacokinetic parameters were computed. The post-dose blood samples were collected at specified time intervals up to 96 h. The pre-dose blood sample was collected within a period of one h before dosing. After an overnight fasting of at least 10 h, the subjects received single oral dose of test or reference product with either of the product as per randomization schedule in each period with a washout period of 10 days. A single dose, crossover bioequivalence study of two different brands of clonidine hydrochloride 25 μg tablets was conducted in 24 (+2 stand by) healthy, adult, male, Indian subjects under fasting conditions to check the implication of enterohepatic re-circulation on assessment of bioequivalence.
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