Mr. Siddheshwar S. Rajurkar, Mr. Avinash G. Wagh, Ms. Ashwini Shelke, Dr. Sunil S. Jaybhaye, Mr. Aajesh B. Andhale
Dr.Babsaheb Ambedkar Technological University, Raigad, Lonere
Abstract
This study been designed to assess bioequivalence of the newly developed delayed-release oral tablets (test) 30 mg nifedipine compared to its marketed counterpart (30 ing: reference) in healthy adult Chinese volunteers. Methode We conducted randomised, open-label, four-period, crossover trials, including a fasting trial and a fed trial. The anhjects. administered the test or reference products in a 1:1 ratio at random throughout each period with 7 days washout period. Then in the next ansidon, they got the alternate products. Lipid chromatography-tandem mass spectrometry and WinNonlin software were used to evtluste the bioequivalence of nifedipine peak blood concentration (Cmax) and area under the concentration-time (AUC). Result A total of 46 subjecta participated in the fasting trial ami 48 subjects in the postprandial trial. In both auses the 90% CL of the geometrica ratios of Cmax, AUCU and AUCH were in the equivalence range (80-125%), When nifedipine was given concomitantly with a high-fat meal, tmax was approximately twofold earlier, absorption was approximately 4.8% less and Conax changed little compared to fasting conditions. In addition, no serious adverse events were observed in the subjects. Conclusion: This study confirus the hioequivalence of the test and reference formulations of nifedipine extended mlense tablets under fasting and postprandial conditions. Food giving kende much earlier Tmax, which is different from the results of other studies. The effect of food effect on the pharmacokinetics of nifedipine needs to be further explored
Keywords: Nifedipine, Matrix tablet, HPMC,Sustained release, HEC Ethyl cellulose, Eudragit RS100, Wet granulation
Journal Name :
EPRA International Journal of Research & Development (IJRD)

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Published on : 2024-11-25

Vol : 9
Issue : 11
Month : November
Year : 2024
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