IMPACT OF RABEPRAZOLE SODIUM ON PHARMACOKINETICS OF NIMESULIDE IN HEALTHY VOLUNTEERS: A PROSPECTIVE STUDY FROM PAKISTAN
ACTA POLONIAE PHARMACEUTICA(2018)
Abstract
Nimesulide is mostly being prescribed along proton pump inhibitors such as rabeprazole sodium to reduce gastric irritation and damage. Therefore, present study was aimed to evaluate the effect of rabeprazole sodium on the pharmacokinetics of nimesulide in healthy adult male volunteers. Healthy volunteers (n = 30) participated in this study. After overnight fasting, blood samples (5 mL) were withdrawn at predetermined time intervals i.e. 0, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 h. After washout period of 15 days, Nimesulide was co-administered with rabeprazole sodium to the same volunteers and blood samples were taken again. Plasma concentration of nimesulide was determined by using HPLC technique. Pharmacokinetic parameters were determined by using pharrnaookinetic software APO, MW/PHRAM version 3.02. Results showed that rabeprazole sodium increased the C-max of nimesulide from 1.21 +/- 0.27 mg/L to 1.79 +/- 0.18 mg/L and AUC was increased from 12.96 +/- 1.34 mg/L.h to 17.46 +/- 1.54 mg/L.h. Clearance and V-d of nimesulide were decreased. Elevated plasma levels of nimsulide were observed due to enzymatic inhibition effect of rabeprazole sodium. Impact of nimsulide on pharmacokinetics of rabeprazole was successfully determined. The knowledge regarding drug drug interaction would be beneficial for the researchers. health care professionals and patients.
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Key words
nimsulide,rabeprazole sodium,drug interaction,pharmacokinetics,crossover design
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