Keller A, Schulz H U
Oranienburger Pharmawerk GmbH.
Arzneimittelforschung. 1994 Nov;44(11):1233-6.
In an open, randomized change-over study the steady state profile of two theophylline (CAS 58-55-9) sustained-release preparations (Theophyllard resp. reference preparation) in 24 healthy volunteers was evaluated with respect to AUC, Cmax, Cmin, and tmax. Cmax of the test preparation is higher than that of the reference. During the daytime the adjusted Cmax-values are about 25% higher than the Cmax-values of the reference, during the night they are 10% higher. Tmax of the test preparation is 6 h; tmax of the reference is 5 h.
在一项开放性、随机交叉研究中，对24名健康志愿者体内两种茶碱（化学物质登记号58-55-9）缓释制剂（Theophyllard及参比制剂）的稳态特征进行了评估，测定参数包括曲线下面积（AUC）、血药浓度峰值（Cmax）、血药浓度谷值（Cmin）和达峰时间（tmax）。受试制剂的Cmax高于参比制剂。白天时，受试制剂经校正后的Cmax值比参比制剂的Cmax值高约25%，夜间则高10%。受试制剂的tmax为6小时，参比制剂的tmax为5小时。
