兩種Sulpiride 錠劑在體內動態學上之比較

Comparative Pharmacokinetics of Two Sulpiride Formulations in Healthy Volunteers

陳英俊(Ing-Jun Chen) ； 楊竹茂(Jwu-Maw Yang) ； 丁乃淳(Nai-Chwen Ding) ； 張慧柔(Huoy-Rou Jang) ； 蔡玉雪(Yuh-Sheue Tsay)

《The Kaohsiung Journal of Medical Sciences》 5卷4期 (1989/04) Pp. 222-230

https://doi.org/10.6452/KJMS.198904.0222

摘要

Six healthy male volunteers(age:27.6±4.7;weight:74.6±7.7)participated in a “repeated measure”design for comparing the bioavaiability and pharmacokinetic be haviours 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 wash-out period, the same dose of a generic preparation was then administered. Blood samples were obtained at 0,0.5,1,1.5,2,4,6,12and 24hours 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 ultilizes 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±0.63and 1.25±0.61hours, the half life (T1/2)was 8.369±1.953 and 8.013±2.602 hours, the area under curve (from 0 to 24 hours)(AUC0-24hr)was11.03,6.78and 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±4.61mcghr/ml, respectively. Based on the data, there was no signigicant difference found between the two groups after statistical analysis with paired t-test (p＞0.05). Therefore, the similarity of these two formulations is then suggested by the authors.
Because a higher single dose of 400mg of sulpiride was administered in the study, which was close to achieving the clinical state, therefore, the results may be useful in encouraging the administration of sulpiride to patients with schizophrenic disorders.

並列摘要

Six healthy male volunteers(age:27.6±4.7;weight:74.6±7.7)participated in a “repeated measure”design for comparing the bioavaiability and pharmacokinetic be haviours 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 wash-out period, the same dose of a generic preparation was then administered. Blood samples were obtained at 0,0.5,1,1.5,2,4,6,12and 24hours 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 ultilizes 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±0.63and 1.25±0.61hours, the half life (T1/2)was 8.369±1.953 and 8.013±2.602 hours, the area under curve (from 0 to 24 hours)(AUC0-24hr)was11.03,6.78and 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±4.61mcghr/ml, respectively. Based on the data, there was no signigicant difference found between the two groups after statistical analysis with paired t-test (p＞0.05). Therefore, the similarity of these two formulations is then suggested by the authors.
Because a higher single dose of 400mg of sulpiride was administered in the study, which was close to achieving the clinical state, therefore, the results may be useful in encouraging the administration of sulpiride to patients with schizophrenic disorders.

並列關鍵字

sulpiride ； pharmacokinetics