Antal E J, Gillespie W R, Albert K S
Int J Clin Pharmacol Ther Toxicol. 1983 May;21(5):257-9.
The relative bioavailability of an orally administered aqueous suspension of medroxyprogesterone acetate (MPA) intended for intramuscular injection (Depo-Provera) was determined in relation to orally administered tablets. Serum levels of MPA were determined by radioimmunoassay following the administration of 400-mg doses to 19 adult male volunteers in a crossover design after an overnight fast. The two treatments were judged bioequivalent based upon a comparison of the resultant MPA serum levels and the derived bioavailability parameters. Hence, the intramuscular suspension administered orally offers an alternative means of achieving optimal serum levels of MPA in patients requiring high dose therapy.
测定了用于肌内注射(Depo-Provera)的醋酸甲羟孕酮(MPA)口服水混悬液相对于口服片剂的相对生物利用度。在19名成年男性志愿者禁食过夜后,采用交叉设计给予400毫克剂量,然后通过放射免疫测定法测定MPA的血清水平。根据所得MPA血清水平和推导的生物利用度参数进行比较,判断这两种治疗方法具有生物等效性。因此,对于需要高剂量治疗的患者,口服肌内混悬液提供了一种达到最佳MPA血清水平的替代方法。