[Comparative pharmacokinetics of two sulpiride formulations in healthy volunteers].
Six healthy male volunteers (age: 27.6 +/- 4.7; weight: 74.6 +/- 7.7) participated in a "repeated measure" design for comparing the bioavailability and pharmacokinetic behaviours of the brand-name drug of Dogmatyl and a generic sulpiride formulation. Each subject received a single 400-mg dose of Dogmatyl in tablet form during the first dosing period. After two weeks of washout period, the same dose of a generic preparation was then administered. Blood samples were obtained at 0, 0.5, 1, 1.5, 2, 4, 6, 12 and 24 hours after initial dosing. The concentration of sulpiride was measured by a high pressure liquid chromatographic method using a UV detector. All the data were processed by Keith K.H. Chan and Kenneth Wnuck's method which utilizes KMCP computer software. Pharmacokinetic parameters were calculated, based on one compartment model. The results revealed that the maximal concentration (Cmax) of Dogmatyl and the generic preparation was 1.468 +/- 0.631 and 1.472 +/- 0.608 mcg/ml, the time to reach maximal concentration (Tmax) was 1.5 +/- 0.63 and 1.25 +/- 0.61 hours, the half life (T 1/2) was 8.369 +/- 1.953 and 8.013 +/- 2.602 hours, the area under curve (from 0 to 24 hours) (AUC0-24 hr) was 11.03 +/- 6.78 and 8.27 +/- 2.99 mcghr/ml, and the area under curve (from 0 hour to infinity) (AUC0-hr) was 13.56 +/- 9.09 and 10.11 +/- 4.61 mcghr/ml, respectively. Based on the data, there was no significant difference found between the two groups after statistical analysis with paired t-test (p greater than 0.05). Therefore, the similarity of these two formulations is then suggested by the authors.(ABSTRACT TRUNCATED AT 250 WORDS)
Chen
I J
IJ
Yang
J M
JM
Ding
N C
NC
Jang
H R
HR
Tsay
Y S
YS
D000328:Adult; D001682:Biological Availability; D002851:Chromatography, High Pressure Liquid; D006207:Half-Life; D006801:Humans; D008297:Male; D013469:Sulpiride / Q000097:blood / Q000493:pharmacokinetics*
D013469:Sulpiride