Pharmacokinetics of bendazac lysine in 10 Chinese young men
Abstract
AIM: To compare the pharmacokinetics of domestic and imported tablets of bendazao
lysine (BL).
METHODS: A single oral dose of 500 mg BL of this 2 kinds of tablets was given to
10 Chinese volunteers of Han nationality in a randomized crossover study. Plasma
levels were determined with HPLC-UV method. Data were analyzed automatically by
using a CAPP program on microcomputer.
RESULTS: The plasma concentration-time curve was fitted to 2-compartment open
model, and the major pharmacokinetic parameters of domestic and imported BL
tablets were shown respectively as following: Cmax 66 +/- 16 and 65 +/- 8 mg.L-1;
Tmax 0.98 +/- 0.22 and 0.98 +/- 0.21 h; T1/2 beta 6.2 +/- 1.8 and 6.2 +/- 1.7 h;
AUC 335 +/- 47 and 337 +/- 58 mg.h.L-1. There was no significant difference
between domestic and imported tablets. The bioavailability of the domestic vs
that of the imported tablet was 99 +/- 12%. The unchanged BL in urine were about
5.4% and 5.6% respectively of the dosage in 24 h after a single oral dose.
CONCLUSION: The two kinds of tablets had the same biological effects.
Keywords:
lysine (BL).
METHODS: A single oral dose of 500 mg BL of this 2 kinds of tablets was given to
10 Chinese volunteers of Han nationality in a randomized crossover study. Plasma
levels were determined with HPLC-UV method. Data were analyzed automatically by
using a CAPP program on microcomputer.
RESULTS: The plasma concentration-time curve was fitted to 2-compartment open
model, and the major pharmacokinetic parameters of domestic and imported BL
tablets were shown respectively as following: Cmax 66 +/- 16 and 65 +/- 8 mg.L-1;
Tmax 0.98 +/- 0.22 and 0.98 +/- 0.21 h; T1/2 beta 6.2 +/- 1.8 and 6.2 +/- 1.7 h;
AUC 335 +/- 47 and 337 +/- 58 mg.h.L-1. There was no significant difference
between domestic and imported tablets. The bioavailability of the domestic vs
that of the imported tablet was 99 +/- 12%. The unchanged BL in urine were about
5.4% and 5.6% respectively of the dosage in 24 h after a single oral dose.
CONCLUSION: The two kinds of tablets had the same biological effects.