[Pharmacokinetics and relative bioavailability of ziprasidone tablets in Chinese healthy volunteers].
OBJECTIVE
To investigate the pharmacokinetics and bioavailability of ziprasidone tablets in Chinese healthy volunteers.


METHODS
A randomized crossover study was performed in 20 healthy volunteers, who received a single oral dose (40 mg) of the test or reference preparation of ziprasidone. Blood samples were collected from the subjects at different time points following the drug administration, and the plasma concentration of ziprasidone was determined using high-performance liquid chromatography. The pharmacokinetic parameters were analyzed by DAS software and the relative bioavailability was calculated according to the formula F=AUC(t)/AUC(r)x100%.


RESULTS
For the test and reference preparation, the pharmacokinetics parameter C(max) was 170.7-/+71.3 and 174.4-/+81.6 ng/ml, t(max) 3.73-/+1.87 and 3.69-/+1.84 h, t((1/2)) 5.57-/+1.62 and 5.61-/+1.73 h, AUC(0-t) 1273-/+252.3 and 1296-/+266.9 ng.h.ml(-1), and AUC(0-infinity)1396-/+276.9 and 1407-/+281.5 ng.h.ml(-1), respectively, with the relative bioavailability of (98.3-/+12.6)%. No significant differences were found in the main parameters of the test and reference preparations as analyzed by ANOVA and two- and one-side t-test.


CONCLUSIONS
The test and reference preparation of ziprasidone are bioequivalent.
Wang
Guang-fa
GF
School of Pharmaceutical Sciences, Southern Medical University, Guangzhou 510515, China.
Chen
Qing-xia
QX
Huang
Wei-qiao
WQ
Liu
Wei-zhong
WZ
Zhang
Jia-jie
JJ
D000284:Administration, Oral; D044466:Asian People; D001682:Biological Availability; D064420:Drug-Related Side Effects and Adverse Reactions; D006262:Health; D006801:Humans; D010879:Piperazines / Q000008:administration & dosage / Q000009:adverse effects / Q000493:pharmacokinetics*; D013607:Tablets; D013810:Therapeutic Equivalency; D013844:Thiazoles / Q000008:administration & dosage / Q000009:adverse effects / Q000493:pharmacokinetics*; D013997:Time Factors; D055815:Young Adult
D010879:Piperazines; D013607:Tablets; D013844:Thiazoles; C092292:ziprasidone