Clinical pharmacology of XXXX by radioimmunoassay.

@entity1 @entity8034 @entity137 @entity390 @entity5 @entity409 @entity391 @entity71239 @entity551
During the phase I clinical trial of a new antitumor agent, @entity71239 , the pharmacology was studied in 18 @entity5 @entity1 . The drug was infused intravenously (IV) for 3 h at doses ranging from 1 to 3.6 mg/m2 per day for 5 days. The plasma drug disappearance curves were biphasic, with a fast initial half-life of less than 15 min. The second half-life ( @entity8034 ) varied from 0.7 to 38 h among different @entity1 and was not dose-related. The difference between the @entity8034 on day 1 and that on day 5 was not significant. In @entity1 with normal liver function, the mean plasma concentration at the end of infusion was 22 ng/ml, and the value of the area under the concentration X time curve (AUC) was 111 (ng/ml)h. In contrast, in @entity1 with @entity409 the corresponding values were 115 ng/ml and 830 (ng/ml)h, respectively. In addition, these @entity1 had a slower elimination half-life of 10.9 h and a decreased total clearance of 157 ml/min/m2, as compared with 2.6 h and 671 ml/min/m2, respectively, for the normal group. All these differences were statistically significant. @entity1 with @entity409 developed more severe @entity137 , including fever, severe @entity390 , @entity391 , and @entity551 . Two @entity1 with severe @entity409 received a reduced dose and developed no @entity137 . These results demonstrated the importance of the effects of @entity409 on drug disposition and showed that the dosage should be reduced in @entity1 with @entity409 .
