Study on the relative bioavailability of Captopril tablets
Fuqiang Xu
Abstract
Fuqiang Xu
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.
Key concepts: Captopril, Bioavailability, Chemistry, Bioequivalence, Pharmacokinetics, Chromatography, High-performance liquid chromatography, Pharmacology