2005Huaxi yaoxue zazhiRequires access

Study on the relative bioavailability of Captopril tablets

Fuqiang Xu

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Abstract

OBJECTIVE To study the relative bioavailability of two kinds of Captopril tablets in human. METHODS 22 healthy male volunteers were randomly divided into A and B groups, 25 mg of Captopril tablets and preparations Capoten tablets were given,respectively. The concentrations of captopril in the plasma were determined by HPLC-MS. The pharmacokinetic parameters were processed with NDST program for variance analysis and two one-sided t test.RESULTS The main pharmacokinetic parameters of the test and reference tablets were as follow: C_~max was 20.99±11.03 and 22.08±10.64 mg·L~-1 ;t_~1/2 was 1.87±0.11 and 1.93±0.11 mg·h·L~-1 ;t_~max was 0.83±0.28 and ~0.85±0.23 mg·h·L~-1 ;AUC_~0-∞ was 63.23±16.80 and 65.10±14.15mg·h·L~-1 , respectively.And the relative bioavailability of the test tablets was 103.5%±13.3%. CONCLUSION The two tablets are bioequivalent.

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OBJECTIVE To study the relative bioavailability of two kinds of Captopril tablets in human. METHODS 22 healthy male volunteers were randomly divided into A and B groups, 25 mg of Captopril tablets and preparations Capoten tablets were given,respectively. The concentrations of captopril in the plasma were determined by HPLC-MS. The pharmacokinetic parameters were processed with NDST program for variance analysis and two one-sided t test.RESULTS The main pharmacokinetic parameters of the test and reference tablets were as follow: C_~max was 20.99±11.03 and 22.08±10.64 mg·L~-1 ;t_~1/2 was 1.87±0.11 and 1.93±0.11 mg·h·L~-1 ;t_~max was 0.83±0.28 and ~0.85±0.23 mg·h·L~-1 ;AUC_~0-∞ was 63.23±16.80 and 65.10±14.15mg·h·L~-1 , respectively.And the relative bioavailability of the test tablets was 103.5%±13.3%. CONCLUSION The two tablets are bioequivalent.

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Available abstract

OBJECTIVE To study the relative bioavailability of two kinds of Captopril tablets in human. METHODS 22 healthy male volunteers were randomly divided into A and B groups, 25 mg of Captopril tablets and preparations Capoten tablets were given,respectively. The concentrations of captopril in the plasma were determined by HPLC-MS. The pharmacokinetic parameters were processed with NDST program for variance analysis and two one-sided t test.RESULTS The main pharmacokinetic parameters of the test and reference tablets were as follow: C_~max was 20.99±11.03 and 22.08±10.64 mg·L~-1 ;t_~1/2 was 1.87±0.11 and 1.93±0.11 mg·h·L~-1 ;t_~max was 0.83±0.28 and ~0.85±0.23 mg·h·L~-1 ;AUC_~0-∞ was 63.23±16.80 and 65.10±14.15mg·h·L~-1 , respectively.And the relative bioavailability of the test tablets was 103.5%±13.3%. CONCLUSION The two tablets are bioequivalent.

Key concepts: Captopril, Bioavailability, Chemistry, Bioequivalence, Pharmacokinetics, Chromatography, High-performance liquid chromatography, Pharmacology

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