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Studies on the bioequivalence of lorazepam tablet in healthy volunteers

LU Xiao-yang

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Abstract

OBJECTIVE To evaluate the bioequivalence of domestic lorazepam tablet and imported lorazepam tablet in healthy volunteers. METHODS A single oral 2 mg test or reference preparations of lorazepam was given to 20 healthy volunteers in a randomized crossover study. The serum concentrations of lorazepam were determined by HPLC-MS assay. RESULTS The main pharmacokinetic parameters of the two products were as follow : tmax,(2.925±1 .017) and( 2.825±0.832 )h; cmax,( 19.642±4.988) and( 20. 185±4.560) ng· mL,-1; A(?) C0-60, (357.62±0.95) and (370.21 ?±88.29)ng·h·mL-1;t1/2(ke)( 14.268±2.790) and( 14.378±3.697) h, respectively.The relative bioavail-ability of the test to reference tablet was ( 103.33±12.32)% .CONCLUSION The results of variance analysis and two one-side t test showed that the two formulations were bioequivalent.

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OBJECTIVE To evaluate the bioequivalence of domestic lorazepam tablet and imported lorazepam tablet in healthy volunteers. METHODS A single oral 2 mg test or reference preparations of lorazepam was given to 20 healthy volunteers in a randomized crossover study. The serum concentrations of lorazepam were determined by HPLC-MS assay. RESULTS The main pharmacokinetic parameters of the two products were as follow : tmax,(2.925±1 .017) and( 2.825±0.832 )h; cmax,( 19.642±4.988) and( 20. 185±4.560) ng· mL,-1; A(?) C0-60, (357.62±0.95) and (370.21 ?±88.29)ng·h·mL-1;t1/2(ke)( 14.268±2.790) and( 14.378±3.697) h, respectively.The relative bioavail-ability of the test to reference tablet was ( 103.33±12.32)% .CONCLUSION The results of variance analysis and two one-side t test showed that the two formulations were bioequivalent.

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Available abstract

OBJECTIVE To evaluate the bioequivalence of domestic lorazepam tablet and imported lorazepam tablet in healthy volunteers. METHODS A single oral 2 mg test or reference preparations of lorazepam was given to 20 healthy volunteers in a randomized crossover study. The serum concentrations of lorazepam were determined by HPLC-MS assay. RESULTS The main pharmacokinetic parameters of the two products were as follow : tmax,(2.925±1 .017) and( 2.825±0.832 )h; cmax,( 19.642±4.988) and( 20. 185±4.560) ng· mL,-1; A(?) C0-60, (357.62±0.95) and (370.21 ?±88.29)ng·h·mL-1;t1/2(ke)( 14.268±2.790) and( 14.378±3.697) h, respectively.The relative bioavail-ability of the test to reference tablet was ( 103.33±12.32)% .CONCLUSION The results of variance analysis and two one-side t test showed that the two formulations were bioequivalent.

Key concepts: Bioequivalence, Lorazepam, Cmax, Crossover study, Pharmacokinetics, Pharmacology, Medicine, High-performance liquid chromatography

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