Study on bioequivalence of Meloxicam Chewable Tablets

VernacularTitle:美洛昔康咀嚼片的生物等效性研究
Author: Run BAI ¹ ; Yang WANG ; hua Hai SHANG ; liang Mao LIAO ; Ri HUANG ; Tian LI
Author Information

1. 天津中医药大学,天津300193
Keywords: meloxicam; bioequivalence; RP-HPLC
From: Drug Evaluation Research 2017;40(9):1254-1258
CountryChina
Language:Chinese
Abstract: Objective To investigate in vivo pharmacokinetics and bioequivalence of Meloxicam Chewable Tablets in healthy Beagle's dogs.Method Twelve healthy adult Beagle's dogs were randomized into two groups.Using the double-preparation,double-cycle,cross-over method and administering orally of testing and reference tablet (2 mg) respectively.The plasma concentration of meloxicam was determinated by RP-HPLC.The 3P97 software was adopted to calculate the pharmacokinetic parameters and evaluate the bioequivalence of two preparations.Results The area under the curves (AUC0-96 h) of the testing tablets and innovator tablets were (2.85±0.64) and (2.79±0.48) μg/mL·h.The peak time (Tmax) was (4.33±0.65) and (4.16±0.71) h.The peak concentration (Cmax) was (0.091±0.017) and (0.086±0.021) μg/mL.The half time (t1/2) was (26.08±3.64) and (26.94± 4.21) h.After the double unilateral t test,there was no statistical significance in the difference of lnAUC and lnCmax between the testing tablets and innovator tablets.Conclusion The testing tablets and innovator tablets are bioequivalent.The relative bioavailability of generic tablet is (98.0±9.76)％.