Shinohara Y, Baba S, Kasuya Y, Knapp G, Pelsor F R, Shah V P, Honigberg I L
J Pharm Sci. 1986 Feb;75(2):161-4. doi: 10.1002/jps.2600750212.
The application of a stable-isotope coadministration technique for estimating the relative bioavailability of 17 alpha-methyltestosterone is described. Eight healthy male subjects were administered orally a single 10-mg 17 alpha-methyltestosterone tablet together with a 10-mg 17 alpha-methyltestosterone-d3 solution. The serum concentrations of 17 alpha-methyltestosterone and 17 alpha-methyltestosterone-d3 were determined by gas chromatography-mass spectrometry with selected ion monitoring using 17 alpha-methyltestosterone-d6 as an internal standard. The extent of absorption from the tablet formulation was comparable to that from the oral solution. The stable-isotope methodology was compared with the conventional cross-over method for evaluating the bioavailability of 17 alpha-methyltestosterone.
描述了一种用于估计17α-甲基睾酮相对生物利用度的稳定同位素共同给药技术的应用。八名健康男性受试者口服一片10毫克的17α-甲基睾酮片剂，并同时服用10毫克的17α-甲基睾酮-d3溶液。以17α-甲基睾酮-d6作为内标，通过气相色谱-质谱联用仪的选择离子监测法测定血清中17α-甲基睾酮和17α-甲基睾酮-d3的浓度。片剂制剂的吸收程度与口服溶液相当。将稳定同位素方法与评估17α-甲基睾酮生物利用度的传统交叉方法进行了比较。
