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| Study on bioequivalence of Captopril Tablets under fasting condition |
| NIE Chang-sheng1 ZHAO Xiang2 CUI Jing2 CHEN Ren-yan2 |
1.Renhetang Pharmaceutical Co.,Ltd.,Shandong Province,Linyi 276600,China;
2.Xiangyu Pharmaceutical Co.,Ltd.,Shandong Province,Linyi 276023,China |
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Abstract Objective To evaluate the bioequivalence between the test preparation of Captopril Tablets produced by Renhetang Pharmaceutical Co.,Ltd.and the reference preparation produced by Bristol-Myers Squibb S.r.l.To provide basis for rational drug use in clinic.Methods A total of 24 healthy adult Chinese subjects enrolled in Zhengzhou Central Hospital from September to November 2019 to study the bioequivalence of the test preparation and reference preparation of Captopril Tablets.A randomized,single-dose,two-preparation,two-period,crossover experiment design was used,and they were divided into the R-T group and T-R group according to random number table method,with 12 subjects in each group.Under fasting condition,R-T group was given single dose of test preparation and reference preparation of Captopril Tablets orally,and T-R group was given single dose of reference preparation and test preparation of Captopril Tablets orally.Two cycles of cross-medication were conducted to obtain 24 samples of test preparation and reference preparation respectively.The test preparation and reference preparation of single dose Captopril Tablets were taken orally under fasting condition.All the data were analyzed by SAS 9.4 software,and the bioequivalence of the two preparations was evaluated.Results The intraspecific variation (CV%) for Cmax,AUC0-t and AUC0-∞of test preparation and reference preparation were below 30%,90%CI of geometric mean point estimate for Cmax,AUC0-t and AUC0-∞of test preparation and reference preparation were 87.82%-100.74%,91.37%-101.35% and 91.47%-101.33%,respectively.All of them were in the range of 80.00%-125.00%,which met the criteria of bioequivalence.Conclusion The test preparation and reference preparation of Captopril Tablets are bioequivalent.
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