Bioequivalence of pravastatin tablet formulations assessed in Korean males.
OBJECTIVE
Determination of the bioequivalence of 2 pravastatin tablet formulations manufactured in Korea.


METHODS
Twenty-three healthy male Korean volunteers received each of the 2 pravastatin formulations at a dose of 20 mg in a 2 x 2 crossover study. There was a 1-week washout period between doses. Plasma concentrations of pravastatin were monitored using high-performance liquid chromatography over a period of 8 hours after administration. AUC(0-8h) (the area under the plasma concentration-time curve from time zero to the last measured time in plasma, 8 h) was calculated using the linear-log trapezoidal method. Cmax (maximum plasma drug concentration) and tmax (time to reach Cmax) were compiled from the plasma concentration-time data. Analysis of variance was carried out using logarithmically transformed AUC(0-8h) and Cmax and untransformed tmax.


RESULTS
The point estimates and 90% confidence intervals for AUC(0-8h) (parametric) and Cmax (parametric) were 1.067 (0.968 to approximately 1.176) and 1.074 (0.999 to approximately 1.155), respectively, satisfying the bioequivalence criteria of the European Committee for Proprietary Medicinal Products and the US Food and Drug Administration guidelines. The corresponding value of tmax was 0.000 (-0.250 to approximately 0.250).


CONCLUSIONS
These results indicate that the 2 medications of pravastatin are bioequivalent and, thus, may be prescribed interchangeably.
Bae
S K
SK
College of Pharmacy and Research Institute of Pharmaceutical Sciences, Seoul National University, Korea.
Kim
E J
EJ
Lim
C H
CH
Lee
J S
JS
Kim
Y G
YG
Lee
M G
MG
D000328:Adult; D019540:Area Under Curve; D001682:Biological Availability; D002851:Chromatography, High Pressure Liquid; D018592:Cross-Over Studies; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000008:administration & dosage / Q000097:blood / Q000493:pharmacokinetics*; D007723:Korea; D008297:Male; D017035:Pravastatin / Q000008:administration & dosage / Q000097:blood / Q000493:pharmacokinetics*
D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D017035:Pravastatin