Klein G, Barkworth M F, Birkenfeld A, Dyde C J, Rehm K D, Töberich H, Cierpka H
Arzneimittelforschung. 1986 Mar;36(3):496-9.
Eight healthy male volunteers took part in this study to determine the relative bioavailability of Treuphadol oblong tablets (500 mg paracetamol), Treuphadol Plus oblong tablets (500 mg paracetamol, 30 mg codeine phosphate) and Treuphadol suppositories (750 mg paracetamol) against commercial tablets (500 mg paracetamol). Plasma levels of paracetamol and codeine, plus saliva levels of paracetamol for the two paracetamol only formulations, were determined by HPLC and the pharmacokinetic parameters established. The AUC data for paracetamol showed that all four preparations were bioequivalent. The saliva levels of paracetamol demonstrated a good correlation to the corresponding plasma levels. The pharmacokinetic data of codeine from the Treuphadol Plus tablet were compared with corresponding data from the literature. The bioequivalence of codeine when based on this comparison can also be assured.
八名健康男性志愿者参与了本研究，以确定曲马多普通片（对乙酰氨基酚500毫克）、曲马多加强型普通片（对乙酰氨基酚500毫克、磷酸可待因30毫克）和曲马多栓剂（对乙酰氨基酚750毫克）相对于市售片（对乙酰氨基酚500毫克）的相对生物利用度。通过高效液相色谱法测定了对乙酰氨基酚和可待因的血浆水平，以及仅含对乙酰氨基酚的两种制剂的对乙酰氨基酚唾液水平，并确定了药代动力学参数。对乙酰氨基酚的AUC数据表明，所有四种制剂具有生物等效性。对乙酰氨基酚的唾液水平与相应的血浆水平显示出良好的相关性。将曲马多加强型片中可待因的药代动力学数据与文献中的相应数据进行了比较。基于此比较，也可确保可待因的生物等效性。
