Jonkman J H, Freie H M, van der Boon W J, Grasmeijer G
Arzneimittelforschung. 1986 Jul;36(7):1133-5.
In a single dose cross-over experiment in twelve healthy adults a comparison of the absorption profiles and the relative bioavailability was made between a new salbutamol containing tablet (preparation A = Salbutax) and a commercially available and accepted formulation as reference (preparation B), both containing 4 mg salbutamol. Salbutamol plasma concentrations were measured frequently during a period of 16 h post dosing. Maximum salbutamol plasma concentrations after intake of product A and product B on an empty stomach were reached after 2.3 +/- 0.9 (= mean +/- S.D.) and 2.4 +/- 1.1 h, respectively, and accounted for 14.3 +/- 2.5 and 12.8 +/- 2.6 micrograms X l-1, respectively. The differences were not found to be significant (p greater than 0.05). The areas under the plasma concentration-time curves (AUC0----16), as obtained after administration of tablet A and tablet B, accounted for 73.5 +/- 14.0 and 65.0 +/- 11.8 micrograms X l-1 X h, respectively, the difference being marginally significant (p = 0.05). This results in a relative bioavailability of 114.3 +/- 15.7% for the product A 4-mg tablets. It is concluded that both products can be considered as having comparable bioavailability.
在一项针对12名健康成年人的单剂量交叉实验中,对一种新的含沙丁胺醇片剂(制剂A = Salbutax)和一种市售且被认可的作为参比制剂(制剂B)进行了吸收曲线和相对生物利用度的比较,两种制剂均含4毫克沙丁胺醇。在给药后16小时内频繁测定沙丁胺醇血浆浓度。空腹服用产品A和产品B后,分别在2.3±0.9(=平均值±标准差)和2.4±1.1小时达到最大沙丁胺醇血浆浓度,分别为14.3±2.5和12.8±2.6微克/升。差异无统计学意义(p>0.05)。服用片剂A和片剂B后得到的血浆浓度-时间曲线下面积(AUC0-16)分别为73.5±14.0和65.0±11.8微克/升·小时,差异有边缘统计学意义(p = 0.05)。这使得产品A的4毫克片剂的相对生物利用度为114.3±15.7%。结论是两种产品的生物利用度可认为具有可比性。