Pharmacokinetics and relative bioavailability of ziprasidone tablets in Chinese healthy volunteers.
- Author:
Guang-fa WANG
1
;
Qing-xia CHEN
;
Wei-qiao HUANG
;
Wei-zhong LIU
;
Jia-jie ZHANG
Author Information
- Publication Type:Journal Article
- MeSH: Administration, Oral; Asian Continental Ancestry Group; Biological Availability; Drug-Related Side Effects and Adverse Reactions; Health; Humans; Piperazines; administration & dosage; adverse effects; pharmacokinetics; Tablets; Therapeutic Equivalency; Thiazoles; administration & dosage; adverse effects; pharmacokinetics; Time Factors; Young Adult
- From: Journal of Southern Medical University 2009;29(8):1561-1564
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVETo investigate the pharmacokinetics and bioavailability of ziprasidone tablets in Chinese healthy volunteers.
METHODSA 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%.
RESULTSFor 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.
CONCLUSIONThe test and reference preparation of ziprasidone are bioequivalent.
