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[Bioequivalence of enteric coated tablet of Zhengqing Fengtongning].

Si-Han Zhang, Yuanda Zhou, HE Hai-xia

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Abstract

OBJECTIVE: To explore the pharmacokinetics and bioequivalence of two kinds of enteric coated tablet of Zhengqing Fengtongning. METHOD: A single dose of 45 mg kg(-1) test or reference preparation was administrated by randomized crossover way in 12 rabbits. The plasma concentrations of drug were determined by HPLC. The pharmacokinetics parameters and relative bioequivalence were calculated with 3p97 program. RESULT: The concentration curves based on drug-time of both test and control preparations were presented by one-compartment model, tmax were (0.81 +/- 0.34), (0.60 +/- 0.30) h respectively, Cmax were (11.16 +/- 0.58), (11.90 +/- 1.44) microg mL(1) respectively, AUC(0-->t) were (61.58 +/- 6.70), (60.56 +/- 6.67) microg h mL(-1) respectively, relative bioavailability was (102.77% +/- 15.63)%. Suggesting no significant diffirence between the main pharmacokinetic parameters of two prepations. CONCLUSION: The two preparations are bioequivalent.

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What this paper is about

OBJECTIVE: To explore the pharmacokinetics and bioequivalence of two kinds of enteric coated tablet of Zhengqing Fengtongning. METHOD: A single dose of 45 mg kg(-1) test or reference preparation was administrated by randomized crossover way in 12 rabbits. The plasma concentrations of drug were determined by HPLC. The pharmacokinetics parameters and relative bioequivalence were calculated with 3p97 program. RESULT: The concentration curves based on drug-time of both test and control preparations were presented by one-compartment model, tmax were (0.81 +/- 0.34), (0.60 +/- 0.30) h respectively, Cmax were (11.16 +/- 0.58), (11.90 +/- 1.44) microg mL(1) respectively, AUC(0-->t) were (61.58 +/- 6.70), (60.56 +/- 6.67) microg h mL(-1) respectively, relative bioavailability was (102.77% +/- 15.63)%. Suggesting no significant diffirence between the main pharmacokinetic parameters of two prepations. CONCLUSION: The two preparations are bioequivalent.

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Available abstract

OBJECTIVE: To explore the pharmacokinetics and bioequivalence of two kinds of enteric coated tablet of Zhengqing Fengtongning. METHOD: A single dose of 45 mg kg(-1) test or reference preparation was administrated by randomized crossover way in 12 rabbits. The plasma concentrations of drug were determined by HPLC. The pharmacokinetics parameters and relative bioequivalence were calculated with 3p97 program. RESULT: The concentration curves based on drug-time of both test and control preparations were presented by one-compartment model, tmax were (0.81 +/- 0.34), (0.60 +/- 0.30) h respectively, Cmax were (11.16 +/- 0.58), (11.90 +/- 1.44) microg mL(1) respectively, AUC(0-->t) were (61.58 +/- 6.70), (60.56 +/- 6.67) microg h mL(-1) respectively, relative bioavailability was (102.77% +/- 15.63)%. Suggesting no significant diffirence between the main pharmacokinetic parameters of two prepations. CONCLUSION: The two preparations are bioequivalent.

Key concepts: Bioequivalence, Pharmacokinetics, Bioavailability, Cmax, Crossover study, Pharmacology, High-performance liquid chromatography, Enteric coated

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