卡马西平市售制剂与卡马西平渗透泵控释片在成人及儿童癫痫患者中的生物利用度比较及稳态波动情况

Comparative bioavailability and steady state fluctuations of Tegretol commercial and carbamazepine OROS tablets in adult and pediatric epileptic patients.

作者信息

Thakker K M, Mangat S, Garnett W R, Levy R H, Kochak G M

机构信息

Clinical Pharmacokinetics and Disposition, Drug Development Department, CIBA-GEIGY Corporation, Ardsley, New York 10502.

出版信息

Biopharm Drug Dispos. 1992 Nov;13(8):559-69. doi: 10.1002/bdd.2510130802.

DOI:10.1002/bdd.2510130802

PMID:1421050

Abstract

The comparative bioavailability and steady state fluctuations resulting from the administration of Tegretol 200 mg commercial tablets and carbamazepine OROS controlled delivery tablets were investigated in 22 adult and 12 pediatric epileptic patients. Tegretol commercial tablets were dosed according to previously established clinical regimens of 400 to 2000 mg daily doses divided into four equal or unequal intervals. Carbamazepine OROS was dosed every 12 h at the same corresponding daily dose. Comparisons of the pharmacokinetic parameters AUC, Cmax, Cmin, and tmax at steady state for the two dosage forms demonstrated definitively the bioequivalence of carbamazepine OROS with Tegretol commercial tablet over a 24-h treatment interval.

摘要

在22名成年和12名儿童癫痫患者中，对服用200mg卡马西平普通片和卡马西平渗透泵控释片后的相对生物利用度和稳态波动情况进行了研究。卡马西平普通片根据先前确定的临床方案给药，每日剂量为400至2000mg，分为四个相等或不相等的间隔。卡马西平渗透泵控释片每12小时以相同的相应日剂量给药。两种剂型在稳态时的药代动力学参数AUC、Cmax、Cmin和tmax的比较明确表明，在24小时治疗间隔内，卡马西平渗透泵控释片与卡马西平普通片具有生物等效性。