Degen J, Maier-Lenz H
Arzneimittelforschung. 1984;34(8):900-2.
After a single dose administration of either 4 suppositories Dolarist -250 (a total of 1000 mg paracetamol, N-acetyl-p-aminophenol) or 4 suppositories of a reference drug registered according to AMG 1976 (a total of 800 mg paracetamol) in 6 healthy subjects, the serum concentrations of paracetamol were determined until 24 h post application. The main pharmacokinetic parameters and the relative bioavailability were calculated. The maximum concentrations of both drugs were similar, however, with Dolarist-250 the serum levels observed after 3, 4, 6 and 8 h were significantly higher. The invasion and elimination rate as well as the relative bioavailability showed no relevant differences.
在6名健康受试者中,单次给予4枚多乐士 -250栓剂(对乙酰氨基酚总量为1000 mg,N-乙酰对氨基酚)或4枚根据1976年药品法注册的参比药物栓剂(对乙酰氨基酚总量为800 mg)后,测定应用后24小时内的对乙酰氨基酚血清浓度。计算主要药代动力学参数和相对生物利用度。两种药物的最大浓度相似,然而,使用多乐士 -250时,3、4、6和8小时后观察到的血清水平显著更高。吸收和消除速率以及相对生物利用度无显著差异。