Abstract
The main purpose of this study was to evaluate the pharmacokinetics of levosulpiride in humans after single and multiple intramuscular injections. Six males and six females received single dose of either 25mg or 50mg levosulpiride, or multiple doses of 25mg every 12h for 5 consecutive days. In the single 25mg study, the mean peak plasma concentration (Cmax) was 441ng/mL, the mean area under the concentration–time curve from 0 to 36h (AUC0–36) was 1724ngh/mL, and the mean elimination half-life (t1/2) was 7.0h. In the single 50mg study, the mean Cmax was 823ng/mL, the mean AUC0–36 was 3748ng·h/mL, and the mean t1/2 was 6.8h. After multiple doses of 25mg levosulpiride, the average plasma concentration (Cav) was 136ng/mL, the fluctuation index (DF) was 3.60, and the accumulation ratio (R) was 1.2. Levosulpiride injections appeared to be well tolerated by the subjects, and can be used for successive administration.
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